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Author: ArcheMedX Team

Atul Mahableshwarkar

Pandemic Impact on Clinical Trial Recruitment with Atul Mahableshwarkar, M.D., DFAPA

Atul Mahableshwarkar, M.D., DFAPA, joins Kelly Ritch, EVP of Product and Clinical Research Solutions at ArcheMedX, to discuss clinical trial methodology. A self-described “trial nerd,” Atul illuminates the make-or-break role methodology plays in a trial’s success and shares his advice and best practices for making positive outcomes possible.

Enjoy this interview by video below, or by subscribing to our podcast on Simplecast, Spotify, or iTunes.

Atul Mahableshwarkar

Dr. Atul Mahableshwarkar is the Senior Vice President of Drug Development at Emalex Biosciences. He is a trained psychiatrist who began his career in clinical practice and academia. Since joining the pharmaceutical industry, he has had the opportunity to learn from both successes and failures in his clinical trial work at companies of all sizes.

Atul shares that early in his career, he was more interested in research than methodology. He credits his colleagues at the time with opening his eyes to the fact that incorrect operations can sink an otherwise viable product. The interest in methodology that that understanding sparked has shaped his career over the last 15-20 years.

Episode Highlights

  • The pivotal role of strong methodology in allowing good products to succeed
  • Atul’s advice for others beginning to design clinical trials
  • What he sees as the greatest challenges clinical trials have in common
  • How teams can help motivate clinical trial participation
  • Where standard concepts of patient-centricity may be lacking
  • How collaboration can help minimize mistakes
  • The Orphan Drug and Fast Track designations Emalex has earned from the FDA, and how other organizations can pursue Orphan Drug status
  • How the pandemic nearly tripled Emalex’s enrollment
  • The importance of supporting sites that may feel threatened by decentralized clinical trials
  • The pandemic-enforced recruitment practices he plans to continue
  • Key considerations in choosing a preferred ratings scale, and what his is
  • Rater training as a misnomer that needs revising
  • How to assess and manage raters appropriately
  • The value of monitoring data and communicating insights to stakeholders in real time

Resources:

Emalex Biosciences
Atul Mahableshwarkar on LinkedIn
https://isctm.org
https://cnssummit.org
Conversations in Clinical Trial Readiness Interview Series

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ArcheMedX Releases New Findings at CNS Summit Revealing Clinician Readiness

The area of clinical research known as CNS (central nervous system conditions) is commonly cited for its complexity and the subjective nature of many assessment tools. CNS clinicians therefore must commit to tackling unique challenges affecting their patients and the research they conduct.

It should be no surprise that the life sciences companies that develop therapies for these conditions prioritize standardization and consistency with their prescribing clinicians.

However, it may surprise you to discover how underprepared many healthcare professionals are to effectively screen, assess, diagnose, and treat CNS patients without the ongoing intervention and educational support provided by these life science companies.

Many of the leading biopharmaceutical companies that develop therapies for CNS, like autism, ADHD, multiple sclerosis, Parkinson’s disease, Alzheimer’s disease, schizophrenia, and depression rely on Ready by ArcheMedX to help them better equip, train, and assess the clinicians responsible for the research – and delivery – of these novel treatments.

And as the annual CNS Summit approaches, the ArcheMedX team has released highly anticipated new findings about how important effective training is for medical professionals in these therapeutic areas. 

Biopharma companies have used the Ready platform to assess and train over 12,000 clinicians at various stages in the CNS therapy life cycle, including clinical trial start up, market development, and clinical practice.

And across these 12,000+ clinicians, ArcheMedX analyzed their readiness against key learning objectives, as well as their improvement after completing training activities using the Ready platform.

The platform identified that 91% did not demonstrate sufficient proficiency to conduct subjective assessments prior to completing training

91% of CNS clinicians need more tailored training on therapies

These data revealed a surprising number of clinicians were not adequately prepared to conduct subjective assessments in clinical trials, or in practice across CNS therapies.

By assessing more than 12,000 clinicians treating CNS conditions as they engaged in on-demand activities powered by Ready, the platform identified that 91% did not demonstrate sufficient proficiency to conduct subjective assessments prior to completing training.

This risk can be reduced by delivering more tailored and impactful education that improves readiness across key learning objectives. Fortunately, these clinicians demonstrated a significant increase in their knowledge and confidence after participating in personalized and highly engaging online training Activities powered by Ready with content provided by trial sponsors and accredited medical educators.

With Ready by ArcheMedX, clinicians increased their mastery of key learning objectives by more than 10x.  In one example, they reduced their misunderstanding about screening and diagnosing CNS treatments by 88%.

Using Ready to deliver CNS content improves clinician capabilities measurably

After completing these CNS specific education and training activities with Ready by ArcheMedX, clinicians increased their mastery of key learning objectives by more than 10x.  In one example, they reduced their misunderstanding about screening and diagnosing CNS treatments by 88%.

Ready achieves this impact by:

  • Transforming your content (i.e., protocols, study documents, or training materials) into an interactive and tailored learning experience.
  • Analyzing clinician engagement and behavior as they learn.
  • Measuring changes in learner behavior, knowledge, and confidence.
  • Delivering targeted remediation to clinicians on-demand.
  • Assessing clinician readiness – to help you identify who is prepared to apply knowledge in the field.

More details are available for download now

Additional details about our findings are available now, or you can request a one-on-one discussion to review these findings in more detail and explore Ready’s capabilities.

Meet the ArcheMedX team at the CNS Summit

Those attending the CNS Summit in Boston, November 7th-9th, can schedule an in-person meeting with the ArcheMedX team. Click here to confirm a time.

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Jennifer Brandl Virtual SIVs

Are Virtual SIVs the Future?: Interview with Jennifer Brandl

Jennifer Brandl joins Kelly Ritch, EVP of Product and Clinical Research Solutions at ArcheMedX, to discuss the feasibility and pros and cons of virtual site initiation visits. A clinical operations expert with a passion for data science, Jennifer shares her experience transitioning from pre-clinical to clinical research and her confidence that data can change the world.

Enjoy this interview by video below, or by subscribing to our podcast on Simplecast, Spotify, or iTunes.

Jennifer Brandl

Jennifer Brandl is the Associate Director of Clinical Operations at Kezar Life Sciences. She has 15 years of experience as a researcher and clinical operations specialist, and she is currently pursuing a Master’s degree in Data Science from the University of Wisconsin.

Jennifer credits her prior experience at a smaller biotech company with giving her a critical foundation in clinical conduct and study execution. At Kezar, she leverages this expertise and her passion for research to support the company’s development of pioneering therapies and to change the lives of patients.

Episode Highlights

  • The elements of Jennifer’s expertise that have especially helped her drive success in the trials she manages
  • The benefits of functional service provider outsourcing models
  • How Kezar’s patient-centric nature had the company well prepared to navigate the COVID-19 pandemic
  • The greatest challenges Jennifer and Kezar experienced due to the pandemic, and some positive outcomes
  • Important considerations for organizations exploring home health options
  • How communication and relationship-building form the foundation of clinical trial work
  • The challenges and benefits she’s experienced conducting site initiation visits virtually
  • How best to prepare before updating or transforming site initiation processes
  • What she believes is next for decentralized clinical trials
  • How automation and tech adoption can help extract more insight from data

Resources:

Kezar Life Sciences
Jennifer Brandl on LinkedIn
Conversations in Clinical Trial Readiness Interview Series

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trial site burden

Webinar: Transforming Study Start Up to Reduce Clinical Trial Site Burden

Watch on Demand Now!

Clinical trials are more complex than ever.
And 85% of them are delayed.

More screening criteria, more procedures, new vendor systems and tools, and more data. So who bears the burden of all this progress? Sites.

Increased site burden means degraded performance, more delays, and more problems for you. But it doesn’t have to be that way.

When a clinical trial is approaching, you have timelines to meet.

You probably have a CRO to onboard.

You have multiple vendor systems to launch, IP to deliver, and sites to activate.

But as hard as you may work, it’s your sites that are under the most pressure.

**They are under increasing financial and resource constraints.
**Devoting enough time to your virtual and onsite visits is incredibly burdensome.
**Onsite work remains challenging with fears of the next COVID variant’s impact.

And most of all, clinical trials are more complex than ever – increasing the clinical and operational burden on site staff.

Since clinical trial sites are not created equal – how can you identify those most capable of accelerating enrollment and conducting the study while you remediate and upskill those more likely to struggle and encounter delays?

Fortunately, there is a critical change you can make during study startup to accelerate time to first patient enrolled while reducing the burden placed on your sites and trial team.

ArcheMedX is pleased to lead a webinar that discusses real clinical trial examples from emerging biotechs that will give you techniques to:

  • Simplify your approach to getting sites trained on your protocol and critical study objectives – earlier and with better results
  • Identify which sites are best prepared to screen and enroll and which sites require additional support and monitoring
  • Tailor your SIVs and remediation so every site you activate is ready to enroll – fast – and with less time and effort
  • Reduce the amount of time your team and sites spend during study startup – by 50%

Register for the On-Demand Webinar here.

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virtual clinical trial software tools

12 Clinical Trial Software Tools You Need to Run a Virtual Trial

It’s impossible to read an industry publication without hearing about virtual clinical trials, decentralized clinical trials, or hybrid trials. Industry leaders and technology companies are touting the advantages and the opportunities to anyone who will listen. You may understand the model, and you may recognize the effort to shift. But do you really know what clinical trial software you need to make these clinical trial designs work? What does it really take?

In this article, we’ll explore the 12 different clinical trial solutions you’ll need, and why you need them.

The clinical trial software you need for virtual, decentralized, and hybrid trials

There are 12 – yes, 12 – solutions you need to conduct the clinical trial itself. This doesn’t include protocol development, the lab equipment, or basic infrastructure. For technology-enabled clinical trials, you will need a solution for:

  • Clinical Trial Training Platform (eLearning)
  • Electronic Data Capture (EDC)
  • Interactive Response Technology (IRT)
  • Clinical Trial Management System (CTMS)
  • Electronic Trial Master File (eTMF) 
  • eConsent
  • Electronic Clinical Outcome Assessment (eCOA and ePRO)
  • Supply Management
  • Electronic Health Record Mining
  • Televisit Platform
  • Patient Engagement
  • Virtual Site Monitoring 

Wow – that is a long list! So let’s dig in.

Clinical trial software for performing your study

Clinical Trial Training Platform

In a virtual clinical trial, even if only hybrid, you lose the ability to manage onsite training. But that means it’s an opportunity to embrace the flexibility of on-demand learning with a clinical trial training platform.

Decentralized teams may span geographies and time zones. Your stakeholders are no longer a captive audience all located centrally. Now that the team delivering a trial is dispersed, you could easily spend days or weeks trying to deliver various sessions to accommodate all. Instead, choose technology that lets you deploy once, update centrally, and allows staff and team members to participate on-demand.

You have to train your clinical trial team, your investigators, caregivers, and other stakeholders. If you get this wrong, you risk releasing under-prepared trial staff into the field. You also must consider how you can scale your efforts across various groups without adding additional staff.

Fortunately, on-demand clinical trial software enables you to both scale training and reduce risk. Ready is an ideal tool as you work to adopt one of the emerging virtual clinical trial design. 

Reframing the PI Meeting

One giant expense and stress point you can cross off your list with a virtual clinical trial is the traditional primary investigator meeting (PI meeting). Especially with dispersed project team members, the expensive, in-person, full-day meeting of the past is even less economical. 

However, you can still equip your PIs – and more efficiently, effectively, and conveniently. Make sure you choose a solution that helps you:

  • Train directly on your existing clinical trial protocol.
  • Augment your content with images, audio recordings, video files and supporting resources and study tools.
  • Emphasize the most critical learning objectives, drive attendees to engage at the right moments and around the most relevant content and resources.
  • Understand attendees’ engagement and focus – and not just whether they attended.
  • Analyze attendees’ knowledge and confidence with the protocol and content you provided.
  • Automate follow up on key learning objectives.

Running a virtual site initiation visit (SIV)

Another headache that virtual and decentralized clinical trials eliminate? The site initiation visit (SIV). With the potential for no sites at all, the last thing you want to do is visit with every PI or caregiver individually.

Instead, with the virtual study startup tools available today, you can move this to the fully virtualized list. When you plan how to deliver the activities that make up the historical SIV, make sure you choose a solution that includes:

  • On-demand content delivery 
  • Site and individual progress through your study content 
  • Data, not a pre-set checklist of tasks, inform and determine how you speed up a PI or staff member, or slow them down.
  • Automate follow ups to keep clinicians and staff engaged

Keeping distributed teams engaged

After the study kicks off, your need to equip your caregivers doesn’t end. Nor does the work involved. But you can greatly reduce the effort – and greatly increase the performance – if you select a clinical trial training solution that offers the features we’ve noted above. You can continue to use the same content (or new information like best practices) to keep improving how sites or caregivers perform.

You may need more ideas in making this shift, so check out what clinical trial readiness really means. Learn more in the Definitive Guide to Clinical Trial Readiness.

Electronic Data Capture (EDC)

The next clinical software solution on the list is electronic data capture (EDC). This tool is a critical piece of the clinical trial because it stores the patient data you collect. Traditionally, patient data is first recorded on paper, and later entered into an electronic case report form (eCRF). 

However, the more decentralized clinical trials become, the greater the need for centralized collection. Just today, I watched my aging parent’s home health nurse arrive, care for him, then take notes in a well-worn notebook that was small enough to easily misplace. 

Home health visits will eventually become a scalable part of technology-enabled clinical trials. Thus, it will be more effective, sustainable, and secure for data to be recorded once. Whether you adopt an off-the-shelf EDC with direct entry or esource capabilities or develop your own process in-house, your EDC platform will provide you features like:

  • Designing eCRFs
  • Real time validation checks to improve direct data entry 
  • Interation capabilities
  • Exporting and reporting data

Clinical Trial Management System (CTMS) 

Some clinical trial sponsors and CROs need a more comprehensive solution for managing clinical trials. Those companies choose to use a Clinical Trial Management System (CTMS), which they may sync with the EDC. 

A CTMS is essentially a project management tool, tailored to the needs of clinical operations teams. Traditionally, many clinical trial teams felt that CTMS tools were too complex for their needs. But virtual and decentralized clinical trials have unique circumstances that make data centralization more important.

Make sure you know what problems you’re hoping to solve with a CTMS, so that you select wisely since these systems can be expensive and complex. Some of the feature areas you will see are:

  • Contact management – sites & teams
  • Document management & eTMF
  • Calendar & monitoring
  • Clinical trial site activities, contracts, and payments
  • Issue management
  • Project plan and timeline tracking 
  • Milestones & tasks
  • Workflows
  • Visit report authoring & letter generation
  • Reporting & analytics

Interactive Response Technology (IRT)

In clinical trials, it’s already common to use a web-based or phone-based tool to allow clinical research sites to interact with your clinical systems. Phone-based versions of IRT have been around at least since the 90s, and in a virtual clinical trial, you’ll definitely need to provide this remote capability. 

IRT systems are valuable for site users like PIs and study coordinator, for CRO project team members, sponsor teams, and CRAs, among others. 

Look for a tool that can allow these stakeholders to do things like:

  • Add and randomize study patients
  • Record IP and kit assignments
  • Record screen failures and other activities
  • Acknowledge receipt of supplies or shipments
  • Track shipments and IP availability

You’ll also need the ability for your own project team to access the data inputs and requests, review progress, manage users, and configure details about the study. Your team may include Clinical Project Managers, Clinical Research Associates (Site Monitors), Clinical Trial Assistants, Medical Monitors, Data Managers, Biostatisticians, and others as needed.

Electronic Trial Master File (eTMF)

Like a few of the other clinical trial software in this list, the eTMF (electronic trial master file) has become standard in clinical research. In addition to housing all of the important documentation about your clinical trial, it also serves to provide a clear regulatory overview for agencies.

Therefore, you must make sure your eTMF software includes:

  • eTMF process management, workflows, and configuration
  • Powerful search, using metadata
  • Uploading, indexing, and managing documents
  • A full audit trail and access controls
  • Electronic signature
  • Strong notification functionality

eConsent

As clinical trials become more and more complex, it becomes harder for patients to understand their responsibility. Making informed consent forms more comprehensive doesn’t help, especially if we’re reducing the face-to-face interactions where patients ask questions.

That’s why a digital approach to informed consent is critical. And the features you need should be fairly obvious, since they should make the traditional process more portable:

  • A simple electronic signature process, that is fully compliant with US 21 CFR Part 11 
  • Support for diagrams, images, videos, and screen readers to enable patient comprehension
  • Online, on-demand access to the supporting documents for patients post-consent
  • An ability for patients to ask questions – and receive answers

However, is this enough to truly inform research subjects? It may not be. 

Are your study documents extremely complex? Are you engaging with research-naive sites or patient populations? If so, you should consider adopting a more supportive approach to informing your participant. Add to the above list the need for:

  • A way to provide an assessment of understanding during the consent process.
  • Support for ongoing engagement with research subjects, to improve the likelihood that they will remain in the study.

Electronic Clinical Outcome Assessment (eCOA)

One of the most critical parts of the actual clinical research process is the intake of patient data. And for any decentralized clinical trial, whether fully virtual or hybrid, you need to find digital methods to collect this data. 

Electronic clinical outcome assessment (eCOA) is an emerging set of technologies that enable clinicians, patients, and site staff to enter outcomes directly in a digital format.

Do you have an eCOA solution among your clinical trial software? If not, make sure you look for one that offers:

  • Data entry by both web and mobile applications
  • Configurable questionnaires
  • Encrypted security
  • Automated notifications
  • Full compliance with regulatory requirements

The last feature on the list may be the most important. If you ensure regulatory compliance, you’ll be safe to use it for any FDA approval research you’re doing without adding burden to your patients.

Many clinical operations leaders find themselves confused when they’re investigating eCOA because of another technology, ePRO. 

What is the difference between eCOA and ePRO?

Electronic Patient-Reported Outcomes (ePro) is one type of eCOA. Where an eCOA solution provides outcomes entry data for multiple stakeholders (including patients, clinicians, caregivers, and others), ePRO is specific to patients.

Do we need a separate ePRO solution?

Any eCOA solution you choose should include ePRO capabilities if you will collect patient reported data. As long as it does, you won’t need a separate ePRO solution.

You should only be investigating separate ePRO software if:

  • Your eCOA tool is not comprehensive enough to include mobile access
  • You won’t use a full eCOA, and will only be accepting patient recorded data digitally.

Combine with eCOA: patient wearable tech

For the collection of biomarker data, you can’t beat wearables like smart watches and wristbands. For one, there’s a low barrier to adoption for patients. Plus, wearable devices optimize data collection with their sensitivity and widely-tested calibration. 

Even though wearables are a fairly mature market, they haven’t been broadly adopted in clinical research. Also, in some research-naive patient populations, you may have to introduce the technology and provide it to the patients.

But combining these hardware devices with clinical trial software that can accept their inputs like an eCOA could be a huge boost to your clinical trial. They offer a simple, real-time way to collect data remotely like walking speed, seizure detection, or perspiration, as examples. 

Enabling diagnostic and biomarker data collection is a critical step in supporting a virtual clinical trial. 

Supply Management

One great need that you must address to accommodate a trial without centralized sites is that of a trackable and traceable supply chain. How do you coordinate the delivery of clinical trial investigational product without a central site? How will you collect specimens from patients?

Even if you’re running a hybrid clinical trial, with some activities at a site and other virtual, you must consider an approach to managing the movement of these items. 

You will need a platform or partner that can help you with not only the movement, but the tracking and monitoring of materials. Since you need to know when to replenish supplies, you’ll need help with reordering, maintaining inventory, and related data management. These could include:

  • Procuring lab kits
  • Delivering and administering IP
  • Biological samples
  • Home health nurse supplies
  • Unused or expired trial materials

Since you will be moving materials across many more locations than a site-based study, consider also that you’ll need support for GPS, real-time tracking, and monitoring on temperature, status, viability, and other factors of care that are specific to biological samples.

Clinical trial software for managing patients virtually

Electronic Health Record Mining or Digital Patient Recruitment 

I’d be remiss if I failed to address one of the top concerns for clinical operations leaders today: patient recruitment. Using electronic health records (EHRs) is on the upswing as a method for creating a large enough sample for a clinical trial.

Also available are sources of real world data and patient communities. With a reduced reliance on a set of centralized sites with their own patient populations, you must shift how you attract patients. While this may seem limiting, it actually broadens your ability to tap into under-represented areas and populations. For rare disease research, in particular, having digital recruitment or EHR mining options can be critical.

Televisit Platform

A televisit or telemedicine platform is probably the most important clinical trial software on this list for the patients. Having access to your investigators, and to clinicians, is what enables you to offer a decentralized clinical trial, or possibly a siteless one.

Instead of visiting a hospital or care center, patients can interact with clinicians via videoconference using these tools. Besides enabling a virtual clinical trial, offering consults this way opens up your access to previously under-represented communities of patients.

Many investigators may already provide such a service to their patients. But, if you need to provide infrastructure to some new areas, make sure you fully investigate televisit software that is purpose built for clinical trials.

You can’t get away with just using meeting software, for example. You need to make sure that the telemedicine appointment you recommend or provide is private, secure, and HIPAA-compliant. If you must offer the platform to your investigators, look for a televisit software with features like:

  • A simple-to-use experience for patients and clinicians
  • Robust scheduling and coordination
  • Advanced video communication technology and screen sharing
  • Secure and private connectivity
  • Communication options for before-and-after care consultations

Patient Engagement

In a decentralized or virtual clinical trial, patients can feel more disconnected from their caregivers. That’s why you must have an approach for patient engagement. 

There are emerging solutions for patient engagement across the healthcare industry, but most of them are not specifically tailored for engaging patients in a clinical trial. So what should you do?

You do need an approach, but you may have a clinical trial software already in your toolkit that can help. Look for something that can help you to:

  • Simplify distribution of updates and information
  • Assess whether patients understand what you and trial staff have shared with them
  • Automate reinforcement of critical details 

Virtual Site Monitoring

Clinical trial teams cling to the on-site monitoring visit. However, if you’re running a decentralized clinical trial, or a siteless trial, your approach to monitoring clinicians and caregivers will have to change.

Traditional on-site monitoring visits aim to ensure sites are following processes, accurately reporting data, and applying the trial protocol correctly. A move towards virtual clinical trials should actually reduce the effort you must expend to do site monitoring. This is for two reasons:

  • Many of the checks that monitors traditionally perform are available in real-time through one of the other clinical trial software solutions on this list 
  • You will have fewer or perhaps no actual sites to visit and monitor in a virtual or decentralized clinical trial

That said, you still must meet the requirements that the traditional onsite monitoring visit addresses. So what is the path forward?

First, you need to ensure that you successfully implement and actively use some of the clinical trial software already on this list, including:

  • eTMF – to assess the consistency of investigative site file documents with the eTMF.
  • CTMS – to check for any deviations or adverse events and necessary reporting status.
  • eConsent – to ensure each subject has been informed, and given consent.
  • Supply management – to ensure drug accountability and storage.

Second, you need to adopt solutions for the remaining objectives of site monitoring. These include:

  • Source document verification – to compare source documents with eCRF data.
  • Assessing compliance with study product 
  • Ensuring processes are followed
  • Supporting patient engagement and oversight 

Clinical trial software needs to support the people and the research 

The clinical trial is a complex mix of people, process, and technology. The most flexible of these is the technology, so make sure you choose clinical trial software that can meet the ever-changing needs you have in your research.

There are still a lot of challenges to address as we shift to decentralized, hybrid, or fully virtual clinical trials. Technology has become the cornerstone for most of our research today, and the use of these clinical trial software solutions makes it easier.

If you’re looking for the first clinical trial software tool on the list, a clinical trial training platform, be sure to register for a complimentary demo of Ready by ArcheMedX.

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Clinical Operations Events 2020

Clinical Operations Conferences Roundup: 34 Events that Are Happening in 2022 [UPDATED]

Updated 16 November 2021.

The clinical operations conference landscape was nothing if not fluid in 2021, so you may be wondering what events focused on clinical research will remain on the calendar. Though many conferences and meetings have gone virtual, many are emerging as in-person or hybrid this year.

To help you keep track of all the changes, the ArcheMedX team put together this handy roundup of the top events we have on our annual calendar, along with some specific details to help you find that perfect clinical operations meeting for the upcoming year.

January Events

Event: Fierce JPM Week

Dates: Jan. 11 (San Francisco, CA) and Jan. 18-22 (Virtual)

Location: Hybrid – San Francisco, CA + Virtual

Cost: $499 through 17 Dec., $599 after. Virtual event only – FREE – but limited tickets.

Relevant topics: J.P. Morgan Healthcare topics, leadership

Every January, the J.P. Morgan Healthcare Conference sets the tone for the year to come. This year, the meeting’s hybrid, so Fierce Life Sciences is bringing you both an in person, and a virtual free event. They advertise a program that goes beyond the panel discussions they’re known for. Using CEO interviews, daily news recaps, and virtual roundtables, they will cover topics from diversity to virtual care.

February Events

Event: SCOPE Summit

Dates: Feb. 7-10

Location: Hybrid: Virtual + Orlando, FL

Cost: Choose virtual OR in-person: $1449 until Nov. 19, $1899 after that date
Access to both virtual and in-person: $2099 until Nov. 19, $2449 after that date

Relevant topics: Protocol development, Feasibility and site selection, Study start-up, Clinical data innovation, Digital endpoints, Real world data, Patient engagement, Enrollment modeling, Enrollment and retention

Cambridge Healthtech, the producer of this event, is a major thought leader in our industry and produces some of the best-attended events in life science. Back after mostly virtual events in 2021, the 2022 event is nearly sold out for sponsors so attendance will likely be at a similar high. Expect to join clinical operations leaders & clinical research innovators from pharma, biotech and academia focusing on why trials succeed and why they fail, as well as budgeting, measurement, and outsourcing.

Event: Outsourcing in Clinical Trials (West Coast)

Dates: Feb. 15-16

Location: Burlingame, CA

Cost: Free for pharma, biotech, and medical device attendees

Relevant topics: Clinical supplies, patient centricity, operational challenges

Part of a regional series of outsourcing in clinical trials events, the west coast edition will enable clinical operations professionals to share knowledge and brainstorm solutions to issues regarding clinical trial outsourcing. Throughout the two days, attendees will enjoy a program of case-study presentations, interactive panel discussions, prize draws and networking opportunities which will enable the audience to discover practical takeaways.

March Events

Event: Decentralized Clinical Trials

Dates: March 7-10

Location: Hybrid – Virtual + Miami, FL

Cost: In-person – $1799, Virtual only – $1199

Relevant topics: Decentralized clinical trials, diversity in clinical trials

This is a new event appearing on our calendars, and it’s coming in with some big promises – particularly that speakers will be delivering actual case studies on decentralized and hybrid clinical trials they’ve run. You’ll also see some focus on diversity and other current topics, but hearing from the clinical operations leaders who are walking the walk in DCTs will be the main draw.

Event: Outsourcing in Clinical Trials (Southeast)

Dates: March 29-30

Location: Raleigh, NC

Cost: Free for pharma, biotech, and medical device attendees

Relevant topics: Clinical supplies, patient centricity, operational challenges

Part of a regional series of outsourcing in clinical trials events, the southeast edition will enable clinical operations professionals to share knowledge and brainstorm solutions to issues regarding clinical trial outsourcing. Throughout the two days, attendees will enjoy a program of case-study presentations, interactive panel discussions, prize draws and networking opportunities which will enable the audience to discover practical takeaways. 

Event: DIA Europe

Dates: March 29-31

Location: Hybrid: Brussels, Belgium + Virtual

Cost: For the in-person event: Members – €1785 until Nov. 17; €2258 after. Non-members – 1964 until Nov. 17; €2483 after. For virtual access only: €2235.

Relevant topics: Real-World Evidence & Data Standards, Pharmacovigilance and Safety, Clinical Development & Operations

Traditionally billed as the intersection of science, healthcare, and regulation, DIA Europe is a strong opportunity alongside the later DIA events. Rebounding from a year of virtual events, this hallmark of the pharmaceutical industry calendar is back in person for 2022. 

Event: FDA Clinical Trial Requirements, Regulations, Compliance, and GCP Conference

Dates: Mar. 30-31

Location: Newport Beach, CA

Cost: Members – $575, Non-members – $650

Relevant topics: FDA Clinical research requirements, Enhancing success through communication and financial incentives, and Assuring confidence in clinical research.

Want real face-to-face time with contacts from the FDA? Do it here. This two-day conference is intended to share information among FDA representatives and the regulated community. Expect a focus on helping you to understand regulations, guidelines and practices, as well as methods and opportunities to enhance your product development experience. The FDA has proven an  ability to adjust for the benefit of the industry during COVID-19. Will that continue?  

 

April Events

Event: ACRP 2022

Dates: Apr. 22-25

Location: Orlando, FL

Cost: Members – starts at $499. Non-members – starts at $699.

Relevant topics: Study Management & Conduct, Regulatory Trends & Compliance, Leadership & Career Growth, Workforce Development, Technology & Future Trends

ACRP made a big change for their 2021 event and made it an all-access pass for year round learning. However, they’ve pulled back on that approach and are back for a one big annual event in Orlando. With a major focus on best practices and advancing your clinical research career, this event is probably best for those in execution and collaboration roles.

Event: SCOPE Europe

Dates: Apr. 20-21

Location: Barcelona, Spain

Cost: €1399 until Dec. 17, €1499 until Jan. 21, €1599 until Mar. 4, €1749 after

Relevant topics: Protocol development, Feasibility and site selection, Study start-up, Clinical data innovation, Digital endpoints, Real world data, Patient engagement, Enrollment modeling, Enrollment and retention

SCOPE Europe is a smaller, newer version of the well-known and well-attended SCOPE Summit, usually held in Orlando. Expect to join clinical operations leaders & clinical research innovators from pharma, biotech and academia focusing on why trials succeed and why they fail, as well as budgeting, measurement, and outsourcing. Plus, any clinical operations conference in beautiful Barcelona is one to check out!

Event: Global Clinical Trials Connect 2022

Dates: Apr. 27-28

Location: London, UK

Cost: £530 plus £106 VAT 

Relevant topics: Bioethics, regulations, patient recruitment, site selection, real-world data, data integration & Strategy, outsourcing, vendor management, quality (QbD) in Trial Conduct, risk-based monitoring

A month later than it was in 2021, Clinical Trials Connect intends to focus on the global health and clinical trials around the world. Focused heavily on innovations across the clinical trial lifecycle, expect to gain better knowledge of the implications of clinical trials in prevention, diagnosis, clinical trial-related ethics and disease treatments.

May Events

Event: MAGI’s Clinical Research vConference East

Dates: May 1-4

Location: Virtual

Cost: TBD, but past prices started as low as $295

Relevant topics: clinical operations, quality & risk management; site management; contracts; budgets & billing; regulatory compliance; management & professional skills

A favorite in the industry, MAGI puts together a multi-day agenda, intended for attendee flexibility. About half of MAGI attendees have leadership roles like CEO, vice president, or director. About three-quarters have eight or more years of clinical research experience. With over 50 sessions, and a thorough online catalog, you will likely find some great content opportunities.

Event: Pharma Clinical 2022

Dates: May 9 

Location: Virtual

Cost: TBD

Relevant topics: Patient-centric clinical trials, digital transformation, decentralized clinical trials

Not much is available about this event yet, but the 2021 conference was a three-day virtual meeting that covered topics highly skewed to decentralizing clinical research. 2022 appears to continue this trend, but also teases some more unique fare, like agile clinical trial design, digital patient recruitment and support, and novel endpoints.

Event: Society for Clinical Trials Annual Meeting

Dates: May 15-18

Location: San Diego, CA

Cost: TBD

Relevant topics: Clinical trial design, Recruitment, Outcomes, Trial management, Trials in crisis

Bringing together a broad swath of the community, this event aims to attract professionals from academia, the pharmaceutical and device industries, government agencies, medical groups and centers, and clinical research entities. Back from being virtual in 2021, this conference features a theme focused on informing public health policy with compelling evidence.

Event: Outsourcing in Clinical Trials (East coast)

Dates: May 24-25

Location: King of Prussia, PA

Cost: Free for pharma, biotech, and medical device attendees

Relevant topics: Clinical supplies, patient centricity, operational challenges

Part of a regional series of outsourcing in clinical trials events, the east coast edition will enable clinical operations professionals to share knowledge and brainstorm solutions to issues regarding clinical trial outsourcing. Throughout the two days, attendees will enjoy a program of case-study presentations, interactive panel discussions, prize draws and networking opportunities which will enable the audience to discover practical takeaways.

June Events

Event: DIA Global Annual Meeting

Dates: June 19-23

Location: Hybrid: Virtual + Chicago, IL

Cost: Early bird rates start at $1399 for members, and $1819 for non-members

Relevant topics: Clinical safety, Early phase clinical research, Patient engagement

Traditionally billed as the intersection of science, healthcare, and regulation, DIA Global usually hosts everything from patients to regulators – attendees from across the spectrum of the product life cycle. This hallmark of the pharmaceutical industry calendar is hybrid this year. 

 

September Events

Event: Clinical Trials in Rare Diseases

Dates: Sept. 13

Location: Virtual

Cost: Free!

Relevant topics: Rare disease research and clinical trials

As the title suggests, this is not a general clinical operations conference. A lot of the usual topics are covered, from decentralized clinical trials to patient recruitment to COVID-19, but every session is specific to rare disease. There will be a heavy session load from sponsors, though, with nearly every other session time taken up by sponsor sessions.

Event: DPharm: Disruptive Innovations to Advance Clinical Trials

Dates: Sept. 13-14

Location: Boston, MA

Cost: TBD, but in 2021 early bird rates started at $600 (virtual) and $1795 (in-person)

Relevant topics: Real world data, Clinical trial readiness, Patient data access and ownership, Digital biomarkers, Modernizing clinical endpoints, Protocol simulation, Big data & AI, Patient-centered trials

Pfizer and Janssen started DPHARM, and are still part of the steering committee. It’s no wonder then that the past speaker list features some of the industry’s heavy hitters; J&J, BMS, Merck, and many others have made an appearance in the past. We expect reasonable attendance from mid-to-large pharma, biotech (all sizes), CROs and sites.

Event: SOCRA Annual Conference

Dates: Sept. 16-18

Location: Orlando, FL

Cost: $750 for non-members includes an annual SOCRA membership

Relevant topics: Site efficiency and effectiveness, Centralized monitoring, Remote monitoring, Regulatory and quality parameters of electronic data records, e-consent, IRB approval

Touting over 1,000+ attendees, SOCRA annual draws investigators, research coordinators, research associates, project managers, consultants, educators, and administrators from across the life sciences industry. There are some great, specific tracks servicing topics like pediatrics, oncology, and behavioral health, as well as broad topics like Site Management and Training. Plus, there are a number of pre-conference workshops available to extend your learning. 

Event: Biotech Week Boston

Dates: TBD

Location: TBD – but 2021 was a hybrid event: Virtual + Boston, MA, USA

Cost: TBD

Relevant topics: Drug development, Manufacturing strategy & bioprocessing, Biopharma alliance trends, Biopharma M&A trends, AI’s potential role in the revolution of drug discovery, Machine learning

With Boston the epicenter of the life sciences industry, this event’s location is likely borne out of convenience rather than a focus on the local community’s interests. Though we’ve yet to see what 2022 will be, the 2021 Biotech Week Boston was a hybrid event, hosted over 10 days in both the city and online. This event tends to be comprehensive, bringing thought leaders, experts, and startups from discovery, financing, event planning, manufacturing, and clinical trials. 

Event: SCDM (Society for Clinical Data Management) Conference

Dates: TBD

Location: TBD

Cost: TBD, but 2021 was $695 for members, $795 for non-members, and group rates available

Relevant topics: AI and machine learning, Data management, Clinical site immersion, Risk based quality monitoring, Patient safety

The Society for Clinical Data Management (SCDM) makes it clear that this is a very focused event, designed to educate and advocate for the data scientists and data managers of our industry. Since it’s virtual, and with a (relatively) low cost to attend, this could be a great upskilling opportunity for anyone interested in becoming more knowledgeable about data management, the future of AI in clinical research, or emerging data management trends.

October Events

Event: Global Site Solutions Summit

Dates: Oct. 7-9

Location: Hollywood, FL, USA

Cost: Early bird rates start as low a s$998

Relevant topics: Site to industry productivity, Process and communication, Business development, Patient recruitment, Social media, Contracts & budgets and Clinical technology

Produced by SCRS (Society for Clinical Research Sites), past attendees to the Global Site Solutions Summit give this event rave reviews. Heavily skewed to the sites, this is a great event for sponsors or CROs that need to network or engage more directly with site leaders. With a mix of debates, sessions, workshops, and focus groups, you will have a diverse set of opportunities to engage with site personnel and leadership.

Event: Outsourcing in Clinical Trials (New England)

Dates: Oct. 12-13

Location: Boston, MA, USA

Cost: Free for pharma, biotech, and medical device attendees

Relevant topics: Clinical supplies, patient centricity, operational challenges

OCT returns to Boston for another one of its regional clinical trials conferences. They tout the aim of promoting successful collaboration among the clinical trials community. The agenda is forthcoming, and so are registration details.

Event: Outsourcing in Clinical Trials (Pacific Northwest)

Dates: Oct. 21-22

Location: Seattle, WA

Cost: Free for pharma, biotech, and medical device attendees

Relevant topics: Clinical supplies, patient centricity, operational challenges

Part of a regional series of outsourcing in clinical trials events, the Pacific Northwest edition will be a face to face event, unlike many of the others – and enable clinical operations professionals to share knowledge and brainstorm solutions to issues regarding clinical trial outsourcing. Throughout the two days, attendees will enjoy a program of case-study presentations, interactive panel discussions, prize draws and networking opportunities which will enable the audience to discover practical takeaways.

Event: Outsourcing in Clinical Trials (Nordics)

Dates: TBD

Location: Copenhagen, Denmark

Cost: Free for pharma, biotech, and medical device attendees

Relevant topics: Clinical supplies, patient centricity, operational challenges

Part of a regional series of outsourcing in clinical trials events, the Nordics edition will be a face to face event, unlike many of the others – and enable clinical operations professionals to share knowledge and brainstorm solutions to issues regarding clinical trial outsourcing. Throughout the two days, attendees will enjoy a program of case-study presentations, interactive panel discussions, prize draws and networking opportunities which will enable the audience to discover practical takeaways.

November Events

Event: Clinical Trials Europe

Dates: Nov. 7-9

Location: Amsterdam, Netherlands

Cost: TBD, but 2021 was free for sponsors, £1799 for CROs

Relevant topics: Partnerships and outsourcing, operations, clinical trials technology, innovation

Clinical Trials Europe brings together clinical industry stakeholders to share experiences, benchmark strategies and discover new ideas. Last year this event was virtual, and focused heavily on COVID’s impact to clinical development.

Event: Collaborating for Novel Solutions (CNS) Summit 2020

Dates: Nov. 7-10

Location: Boston, MA, USA

Cost: Starting at $2195

Relevant topics: Clinical development, Digital Biomarkers, Artificial intelligence, Digital therapeutics, Real world evidence, Decentralized clinical trials, Ecosystem Financial Viability, Neuroscience, Regulatory Issues, AR/VR/XR, Voice as an Endpoint

One of the few clinical operations conferences offering year round events as part of your registration, CNS Summit is a well-known and well-attended event for those in the central nervous system therapeutic area. CNS usually brings 750+ clinical development leaders from small, mid-size, and big pharma, CRO’s and service companies, technology companies, and research sites. But some things have changed – the event has moved this year to Boston, instead of Boca Raton. They also now require you to “Apply” to attend in order to balance attendance. 

Event: Clinical Trials Summit

Dates: TBD

Location: TBD, but 2021 was virtual

Cost: TBD

Relevant topics: Trial management, including Patient recruitment and retention, Patient engagement, Site selection, Study start-up, Data Analytics, Integrating Data and Tech into Clinical Trials, Risk-Based Monitoring

Advertised as hosting only around 80 attendees, and with a focus on senior leadership, this event requires some vetting to allow you in. The summit places a heavy emphasis on networking and collaboration, highlighting more than 12 networking hours and an executive lunch (when in person).

Event: Pharmaceutical Research & Innovations in Pharma Industry

Dates: TBD

Location: Vancouver, BC, Canada

Cost: TBD, but 2021 started at €454 Early bird pricing

Relevant topics: Clinical study designs, clinical trials, CRO/sponsor clinical trials, outsourcing, clinical and medical case reports

This may be the broadest-reaching conference on this list that includes clinical operations topics. There are 22 different tracks, with one dedicated to clinical trials. If you’re looking for a clinical operations conference that has it all – or if you wear hats across the entire drug development lifecycle, this event could be a good fit. If not, it may be too broad to offer strong clinical content.

Event: Outsourcing in Clinical Trials (DACH)

Dates: TBD

Location: TBD

Cost: Free for pharma, biotech, and medical device attendees

Relevant topics: Clinical supplies, patient centricity, operational challenges

Part of a regional series of outsourcing in clinical trials events, the DACH edition will be a face to face event, and enable clinical operations professionals to share knowledge and brainstorm solutions to issues regarding clinical trial outsourcing. Throughout the two days, attendees will enjoy a program of case-study presentations, interactive panel discussions, prize draws and networking opportunities which will enable the audience to discover practical takeaways.

Event: Outsourcing in Clinical Trials (East Asia)

Dates: TBD

Location: TBD

Cost: Free for pharma, biotech, and medical device attendees

Relevant topics: Clinical supplies, patient centricity, operational challenges

OCT Southeast Asia is a clinical trials conference that will be in-person this year. Co-located with Clinical Trial Supply East Asia, the event aims to enable clinical operations professionals to share knowledge and brainstorm solutions to issues regarding clinical trial outsourcing. Throughout the three days, attendees will enjoy a program of case-study presentations, interactive panel discussions, prize draws and networking opportunities which will enable the audience to discover practical takeaways.

Event: SOCRA FDA Clinical Trial Requirements, Regulations, Compliance and GCP Conference

Dates: TBD

Location: Virtual

Cost: TBD, but in 2021 costs were Members – $100, Non-members – $175.

Relevant topics: FDA Clinical research requirements, confidence in clinical research, relationships between FDA and clinical trial staff

Designed to facilitate information-sharing among FDA representatives and the regulated community, this event is virtual and scheduled for three days. Expect to focus on the understanding of regulations, guidelines and practices, and to learn suggested methods to enhance your product development experience. 

December Events

Event: Outsourcing in Clinical Trials (Southern California)

Dates: TBD

Location: San Diego, CA

Cost: Free for pharma, biotech, and medical device attendees

Relevant topics: Clinical supplies, patient centricity, operational challenges

Part of a regional series of outsourcing in clinical trials events, the southern California edition will be a face to face event, unlike the others – and enable clinical operations professionals to share knowledge and brainstorm solutions to issues regarding clinical trial outsourcing. Throughout the two days, attendees will enjoy a program of case-study presentations, interactive panel discussions, prize draws and networking opportunities which will enable the audience to discover practical takeaways.

Event: Outsourcing in Clinical Trials (UK & Ireland)

Dates: TBD

Location: London, UK

Cost: Free for pharma, biotech, and medical device attendees

Relevant topics: Clinical supplies, patient centricity, operational challenges

Yet another of OCT’s regional series of outsourcing in clinical trials events, this time in the UK. Big name attendees include GSK, Biogen and MHRA, and they’ve taken a slant towards sponsor-CRO relationships in this agenda. 

Event: 5th Virtual Clinical Trials

Dates: TBD

Location: Virtual

Cost: TBD

Relevant topics: Virtual clinical trials

There is little information about the agenda online, but the few speakers noted come from either industry vendors that are focused on virtual clinical trials, or big pharma. Emphasizing that attendees need to reimagine their entire clinical approach to accommodate clinical trials, you should expect specific sessions all about digital trials, or at least the idea of doing them. 

Didn’t find the perfect clinical operations conference for you?

We’ve probably missed a few, and the list of available webinars and resources is growing daily. If you’re especially missing the individual insights that meetings provide, check out our interview series, “Conversations in Clinical Trial Readiness” to get that personal touch. 

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Peju Oshisanya

Increasing Access to People of African Descent in Pharma: Interview with Peju Oshisanya

Peju Oshisanya joins Kelly Ritch, EVP of Product and Clinical Research Solutions at ArcheMedX, to discuss diversity and inclusion in clinical trials. An experienced clinical operations specialist and a strong advocate for data diversity, Peju shares her insight into the health sciences industry, evaluates opportunities for improvement, and illuminates the path forward.

Enjoy this interview by video below, or by subscribing to our podcast on Simplecast, Spotify, or iTunes.

Peju Oshisanya

Peju Oshisanya is a Director and Clinical Program Leader at BenevolentAI. With more than 20 years in the drug research industry, Peju is an expert in pharmaceutical organization. Her career has run the gamut from early roles as a clinical trial associate to extensive experience running a wide range of global clinical research programs. In her role at BenevolentAI, she pairs her biomedical science background with further perspective from the tech side.

Peju is a passionate proponent of diversity in data and inclusion in clinical trial research. She believes that problems of diversity and inclusion are fixable, and she has determined to become a champion of that change, working to raise awareness and dedicating her own career to upend the status quo.

Episode Highlights

  • Peju’s “aha” moment that drove home the magnitude of inequity in biopharma, health, and clinical trials
  • Why it’s crucial to really understand the communities that we want to include in research
  • How decision-makers’ personal perspectives influence which diseases are prioritized and which treatments are funded
  • Why representation needs to extend to the experts rather than stopping with the patient population
  • Why it’s misleading and counter-productive to frame populations using the term “minority”
  • How helping patients understand the importance of research in informing treatments can help motivate participation
  • The huge potential opportunity Africa represents for clinical trials
  • The problem of perception when it comes to African institutions’ preparedness
  • How mining past data can create a self-perpetuating cycle that prevents capable sites from becoming experienced sites
  • What we can do to help ameliorate diverse patient populations’ trust in the healthcare industry
  • How anyone, regardless of their role within a company, can take steps to influence diversity in research
  • How the pandemic has signaled hope for diversity and inclusion going forward

Resources:


Peju Oshisanya on LinkedIn
BenevolentAI
Conversations in Clinical Trial Readiness Interview Series

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managing clinical trials despite complexity

Successful Clinical Trial Management Now Means Accepting Complexity. Here’s How to Deal with It.

If it shocks you to hear that clinical trials are getting more complex, you haven’t been paying attention. Specifically, we’re collecting more endpoints. We’re performing more procedures. We’re increasing nearly every executional variable, like the number of countries, the number of sites, the number of visits per patient, and the volume of data.

In fact, during our recent interview with Ken Getz of Tufts Center for the Study of Drug Development, he pointed out that over the past 20 years, they’ve seen this become a consistent trend. 

But is the industry’s approach to clinical trial management making appropriate shifts? Making it through a clinical trial takes a lot of effort under normal circumstances. But today, with more data, sites, processes, and systems – it’s even more difficult. 

Complexity in clinical trials isn’t bad

There are so many factors that contribute to the growing complexity of clinical trials. For example, we’ve seen a greater focus on rare disease therapies and more companion diagnostics. More precision medicine emerges each year, especially in oncology, which requires greater trial preparation as we outlined recently in our interview with Krystyna Kowalczyk of Oncobay. These kinds of treatments require researchers to collect more biomarker and genetic information at every step, even as early as screening. 

Further, decentralized clinical trials and hybrid clinical trial protocol designs add complexities in execution as the industry adopts them at a more rapid pace.

And these complexities bring some great advantages. Some of the additional data leads to insights into new disease targets, or new applications for existing treatments. The adoption of more complex trial designs will bring clinical research to patients and communities previously inaccessible. 

So, though more complex, these shifts mean progress, and hope for patients. Is complexity inevitable? Likely, yes – and so succeeding with clinical trial management in the future will require clinical operations leaders to accept that.

But trial protocol complexity degrades performance

Despite the benefits that this progress brings, Tufts research has found some drawbacks. In fact, clinical trial protocol complexity is inversely correlated with performance across all measures. Whether duration of the trial, from start-up to first patient in, and even closeout, performance decreases as complexity increases.

The more complex the protocol, the longer that cycle times are. More complex protocols also have far worse failure rates and dropout rates. Complex designs see much higher numbers of protocol deviations. They also experience a much higher relative number of protocol amendments.

The complexity will continue, so clinical operations leaders must find ways to adapt. More effective understanding of sites’ clinical trial readiness is a critical need in order to achieve a fast and smooth clinical trial start up. And better preparation leads to faster start up and is the best way to counteract the well-documented growth of clinical trial delays. 

Effective clinical trial management in the future will require you to prioritize readiness of sites, teams, and caregivers

There was a time that leaders emphasized simplification of the clinical trial design. However, Getz acknowledged in our conversation with him that this was not the right goal. Reducing the number of procedures, or visits, or data endpoints is not realistic today.

Instead, he recommended a mitigation mindset. We have to find models of clinical trial management that promote success despite the growing complexities. This is especially true as we move into hybrid clinical trial models, where some patients will choose to participate remotely, and others in-person.

This is why we have to emphasize preparing and equipping people in a better way. Training the way we’ve always done it doesn’t fit a more complex future.

Data will be collected from new and complicated tools. It will come from various sources that have to be learned, installed, and integrated. Processes will involve patients that may be from remote regions, or caregivers that are in disparate timezones. 

We must do better for our sites, caregivers, and patients. We can do that by adopting better training methods, and by better analyzing their real understanding of the content to identify where they need more support. 

Clinical trial readiness as a benchmark

Using clinical trial readiness as the primary benchmark for selection of trial sites and team members also reduces delays, costs, and risks. An estimated 85% of clinical trials will experience delays, and site and staff readiness are major factors in delays. Clinical trial readiness is an overlooked, yet critical, way to increase the likelihood of a successful enrollment and ongoing study today.

Teams and sites that are better prepared are more likely to successfully recruit patients, provide better patient experiences, avoid protocol deviations, and meet deadlines. 

From the sponsor’s perspective, clinical trial readiness mitigates risk in the face of complexity. Assessing and striving for clinical trial readiness enables project team leaders to better anticipate how their teams will perform.

Clinical operations leaders want to improve readiness

Before COVID-19 impacts hit, most life sciences organizations felt that they were effective in identifying site readiness and addressing issues. In fact, 76% said they were effective in identifying which sites were ready to start recruiting. 

But the pause we took in 2020 likely put things into a new perspective. In our COVID-19 report, we discovered that 78% said they need to improve how they identify sites that are ready to perform. 

Want to improve clinical trial site readiness graph

 

A concept like clinical trial readiness, specifically trial site readiness, has been a disregarded but problematic reality for too long.

But understanding readiness will allow us to more efficiently spend time better preparing individuals to take part in complex clinical trials. 

What clinical trial readiness means in practice

What is clinical trial readiness? We write about this topic in great detail, but in summary: readiness is a measure of how prepared an individual, team, or site is to perform during a trial. 

Readiness can be measured in a number of ways, like:

  • Level of comfort with key study outcomes.
  • Ability to make good decisions in patient eligibility.
  • Confidence with SOPs and systems.

As the protocol, and the processes, become more complex and nuanced, those performing a clinical trial need more and better support. We must find ways to prepare them for the challenges ahead, especially new ones.

For more details, you can grab our comprehensive guide to clinical trial readiness.

Here is a very real example. In our podcast, Getz shared that Tufts has been doing more research into patient dose non-adherence. The group estimates that about half of all patients will intentionally not take at least one dose. 

How are you preparing your sites or caregivers to deal with this? You can – and should – address it directly.

  • Train site staff and caregivers on patient non-adherence.
  • Assess their ability to work with patients to prevent non-adherence, and proper intervention and follow-up.
  • Analyze who needs more support, and who is best equipped to address the issue.
  • Gather feedback and insights around how to better help sites, caregivers, and even the patients themselves to adhere to the dosage.
  • Distribute best practices from the site staff and caregivers who have proven to be ready.

Clinical trial management solutions can help you now

The clinical trial is a complex set of processes, with many steps and people involved. The more complex the protocol, as well – the more risk there is to the timeline. 

And if you don’t meet study timelines in the trial start-up, it greatly impacts the likelihood of missing other study milestones in the future. This is why it’s so important to prioritize the success of our sites and participants. Knowing who needs help – and in what area – will move everyone ahead faster.

Don’t look at growing complexity as a problem, but instead as an opportunity to drive overdue improvements. It is a reason to establish new and better processes to pave a path for running better trials. An opportunity to better support the site staff who will be caring for patients as they test your therapy. A step towards reducing your risk and error. And for embracing a future where you may run a truly decentralized clinical trial, or even a fully virtual trial. 

Technology will make this shift much easier, and it can also deliver benefits to the rest of your team if you recognize these three challenges, and plan for them. Ready by ArcheMedX can help you improve your clinical trial start up, while you improve your site and team performance (and ease their workload, too).

Successful clinical trial management as complexity grows is going to require a focus on better preparing everyone in your trial. The first thing you need is an approach, and clinical trial readiness is an ideal one. Learn more in the Definitive Guide to Clinical Trial Readiness.

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cost of clinical trials climbs

As the Cost of Clinical Trials Climbs, Here Are 3 Ways to Save

By all accounts, the cost of clinical trials continues to rise. We hear reasons that include increasing protocol complexity, patient recruitment struggles, or regulatory challenges. And we shrug our shoulders. Most of us accept these rising costs and obstacles as a given.

But – why?

If you could predict the future problems and risk areas for your upcoming clinical trial, you’d make changes, wouldn’t you? 

Over the past year, we’ve been researching how much of the cost of a clinical trial is wasted. That is – money spent on unnecessary activities, or spent while waiting to get through preventable delays. Unsurprisingly for most clinical operations leaders, the largest part of wasted budget comes from those delays.

By analyzing and applying decades of clinical trial data, we produced a benchmark data powered clinical trial calculator. And we’ve been using it to model upcoming clinical trials to reveal where these budget line items could be reduced. So now, in this article, we’re going to share some of the biggest takeaways from where clinical trials are throwing money away.

The math behind the calculations around the cost of clinical trials

Before we get to the biggest cost drivers in clinical trials, let’s explore how many of these calculations are derived.

First, there are a number of widely cited and accepted industry standards. For example, our colleagues at ACRP tell us that CRA turnover at CROs is a whopping 30%! 

Similarly, we know that a typical turnover for clinical support staff is around 16%, from MGMA. 

These two data points alone reveal the great burden that sponsors (and CROs, and sites) have to shoulder. These are risks that are accepted, but not addressed – at least not proactively.

In addition to including data standards around turnover, we incorporated well-documented cost averages for specific activities during site startup, such as traditional PI meetings and SIV visits. We also cross-referenced multiple resources like Kunal Sampat’s ultimate guide to the cost of clinical trials. 

We also validated our models utilizing resources like Clinical SCORE and Science Direct to reveal standards around the average delays in clinical trials and site performance. Based on our intensive industry research and real world evidence (validated through scorecard exercises run on currently active clinical trials), we confirmed that the greatest unnecessary cost in clinical trials is the result of preventable delays.

By preventing delays, you’ll see a major clinical trial cost reduction

After analyzing mountains of clinical trial data with our scorecard, delays were a major contributor to budget waste. If we could prevent just a measly 20% of the delays, we’d see a huge reduction in the cost of clinical trials.

Complexity was a primary red flag for expanding the cost of clinical trials.

Complexity is not easy to define, because it’s a combination of so many pieces. As we discussed in our recent podcast episode with Ken Getz of Tufts CSDD, one factor is the growing amount of data collected. Other factors include the number of sites, therapy area, intensity of patient care, and lab environments. 

The more complex a trial is, the more likely the occurrence of delays. Those delays can be because:

  • Sites are slow to enroll because they’re not ready.
  • Trial sites that fail to enroll patients altogether.
  • Sites enroll ineligible subjects.
  • Data has to be tossed out because of deviations.

Case study: a fully outsourced Phase II biopharma clinical trial

We ran a scorecard for a biopharma who is fully outsourced to CROs on their Phase II study. It comprised 12 months with just 6 sites. 

After we ran their scores, we found a high risk of delays due to complexity. Some of their specific factors were:

  • Therapy area – some areas, like oncology and cell/gene therapy – are more complex by nature.
  • Protocol design – more complex, as self-selected by the biopharma.
  • Being fully outsourced to CROs.

This translated to wasting over 10% of their budget.

The total waste was $1.2 M. Most of that waste came from preventable delays from our scorecard exercise. With a trial this small, that was an eye-opening amount that could be saved. Unsurprising, the larger the trial, the more potential for delays – and the greater the savings we can find with the scorecard.

This clinical trial pre-startup scorecard finds ways to slash the cost of clinical trials. Want to try it out?

Cut the unnecessary work that fuels the growing cost of clinical trials

There is so much work that needs to be done to begin a clinical trial. Just starting up is a herculean task.

And contract research organizations know this. So while you will see huge proposals from many CROs, what you won’t see is a push to reduce the manual and mundane activities they’ve always done. 

But sponsors have control, and some CROs are pushing innovation as a value proposition. So where can you cut? 

Content creation

Months of time, and a myriad of people, go into the development of the clinical trial protocol. More still to create supporting materials, and the monitoring plan. The work has been done to perfect the content. 

So why spend more hours, and possibly weeks, to move those assets into a slide deck? 

It is – quite simply – redundant work. And even worse, this wasted effort leads to worse trial performance, not better. Why? Many times, trial teams don’t spend time to craft SIV decks well, leading to confusion around the protocol and key study documents.

There has to be a better way to initiative sites. Instead, digitize the protocol and deliver your study content directly to your sites. Tailor it to each individual’s role in the study and save all of that time generating bad slide decks. Tools like Ready make this simple for you – and engaging for them. Your clinical trial team and sites need a better way to consume and understand the protocol. Why add to their burden with more slide decks they either ignore or worse, confuse them?

The investigator meeting

Even one small in-person PI meeting can be extremely expensive. And not just in money – it’s a cause for stress on every site that has to attend. Hours away from their day-to-day role creates additional burden on them and their patients.

Plus, whether you’re planning an in-person meeting, or a virtual one, we’ll always have the possibility that some, or most, of your PIs will be unable to meet at a specific time. That likelihood grows the longer the meeting is. 

So why would you choose a live web meeting when you can make it available to attendees on-demand? 

Cut the giant budget line item, and deliver your streamlined content online, and on-demand. Save your sites and trial team the burden of attending, too. 

And more importantly, let the data that can be captured in an on-demand learning experience inform your understanding of which PIs and site personnel are actually ready to enroll patients.  Don’t waste more time by scheduling an SIV when the PI and coordinator have little to no understanding of your protocol.

The site initiation visit

Speaking of burden (especially when the site is unprepared for the visit), have you considered the impact to a site during a SIV? Is the visit a true value-add to your process, and to the site staff? Or is it just another hoop through which they must all jump?

With the virtual study startup tools available today, you should be taking a closer look at the possibility of re-imagining and overhauling this task. 

With a new mindset on how you can approach SIV, deliver content on-demand ahead of a planned live/virtual visit, you can monitor each site’s progress through your study content – and then tailor the live activities to their schedule – and their needs. Let the data, not a pre-set checklist of tasks, inform and determine how you speed up a site, or slow them down.

Tailor follow ups to just the topics they’re struggling with. Monitor individual site staff, and suggest they make changes based on people when necessary. 

Reducing the effort in all of these areas will also slash the number of unnecessary site visits and travel for your CRO’s team.

Bottom line: don’t sign a CRO proposal without getting your scorecard and finding how you can save on SIVs. There are many clinical trial costs you can quickly eliminate!

This clinical trial pre-startup scorecard can reveal major contributors to the cost of clinical trials. Want to try it out?

Don’t ignore site performance as a contributor to the cost of clinical trials 

One troubling benchmark we found revealed that as much as 86% of clinical trials do not meet recruitment targets on time. How many sites did you have to close down last trial?

Many clinical trial sponsors – and CROs – ignore site failure as “inevitable.” This is a mistake. 

Activating sites that aren’t ready or equipped to enroll will create huge amounts of wasted budget for your trial. You can – and should – take a more informed decision.

Using Ready, for example, to understand which sites are truly prepared to enroll fast and succeed in your trial, you will avoid these delays and the related budget.

Another performance risk is turnover: you can not prevent it. Site staff will transition and occasionally leave your study.

And that staff turnover means you incur the cost of training the replacements for your ongoing clinical trial. This typically occurs in person, and requires time from site staff. It also can demand hours of support and sometimes travel costs from the CRA. 

But you can plan for this, and reuse your virtual startup initiatives to prevent additional delays and costs due to that turnover. Using Ready, for example, also helps speed the onboarding process, which improves quality while efficiently generating the data necessary for proper oversight.

Case study: a fully outsourced phase III biotech clinical trial

We ran our scorecard against the Phase III clinical trial for a biotech that outsources fully to CROs. After running their scores, we could forecast that they would experience a 21% turnover in the study team during the trial. 

While this is based on typical turnover, it creates a greater risk for a biotech like this one, with a very high complexity in their protocol and therapy. That means that even average turnover creates a burden on both the trial team and the sites.

That turnover was a major contributing factor to the $2M of budget waste we found. By simply creating a plan for automating onboarding and training, they could eliminate about 10% of that waste immediately.

Doing so using a strategic approach to study startup with something like Ready for clinical trials would prevent the risks that would lead to the remaining 90% of the waste. 

Upfront planning can save you a lot of money – and accelerate your clinical trial

It’s easy to look the other way when it comes to cost savings. After all, you plan your budget expecting delays and risks.

But what if you prevented those. Where else could you spend that budget? 

More importantly, what if you could hit enrollment targets sooner, and complete your clinical trial earlier? Who would benefit? The patients who need that therapy.

Using a free calculator can compare your clinical trial details against four indicators of clinical trial performance. Try it for your next trial, so you can start up with confidence. And you’ll be well on your way to slashing the cost of clinical trials you have planned.

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decentralized clinical trials mean training at scale

A Decentralized Clinical Trial Requires Training at Scale. Here’s What That Means.

The decentralized clinical trial is one of the most talked-about emerging trends in the life sciences industry. These sorts of clinical trials present immense benefits, as we wrote about in a recent blog.

If executed well, the decentralized clinical trial design could both reduce resource consumption and accelerate treatments arrival to the patients that need them.

But to realize the benefits of a decentralized trial, it’s important to understand that decentralization means education at scale. It means training at scale. Because obstacles like patient treatment adherence, consistency of performance, and data collection loom large, it means you have to find a way to educate and train, assess, and then probably re-train in a way that doesn’t stretch your resources.

And it’s realistic today – if you can implement a few key changes. 

Decentralization means a focus on results, not just training.

In the traditional clinical trial design, you have the ability to look at very discrete activities that can be tracked and completed. Each investigator or site can become a milestone on the big-picture plan.

But in a decentralized clinical trial, you lose some of the core group dynamics that come from the reliance on centralized study locations. You could be working with people in faraway regions who are much less experienced than you in clinical research. Or you may encounter healthcare practitioners with only a single patient. Or – you may be engaging with mobile nursing or care teams.

Traditional clinical trial site training was created for a scenario where people are face to face with an instructor, and perhaps have one another to lean on afterwards.

As we decentralize clinical operations, we have to shift away from the idea of “completing the training task” and shift into the concept of “driving results.”

And in case “results” feels too obtuse, let’s get specific. Start thinking about how you equip your trial team to:

  • Meet your overall enrollment targets. Where a centralized clinical trial site may have had specific site targets, a decentralized trial design doesn’t mean that.
  • Avoid deviations. Decentralization opens the opportunity to participate in a clinical trial to many more patients (and their caregivers) who may not have a lot of exposure to the process.
  • Deliver the data and results effectively. There are going to be questions, and lots of retraining. If you accept that, and plan to make and maintain clinical trial readiness as a goal for your trial team members, you will reduce the effort on your part – and on caregivers’ parts.

 

A decentralized clinical trial demands quality control. Don’t make that more work – it should be less. 

Excited to spend days turning your protocol document into a 200 site initiation presentation? No?

Good, because that’s wasted time. When thinking about a decentralized clinical trial, you need to ensure quality and consistency. Your goal should be to see how much you can reuse to reduce your workload.

There is no good reason to convert everything to a slide deck, when learning platforms like Ready by ArcheMedX make more effective training directly on the protocol possible.

Focus on the content you’ve already gotten approved. Then spend a fraction of that time you were planning to invest in converting that slide deck into a far more useful exercise. Instead, use a platform like Ready to create learning moments and resources that focus each learner’s attention on the key points that need emphasis.

You’ve saved dozens of hours on slide creation, so use it to build content that emphasizes critical protocol points.

Protocols are rarely optimized for use by trial site staff, doctors, or personnel. This can become even more critical in a decentralized clinical trial. So think critically about where a set of new eyes might miss a point. 

Where could a caregiver need more detail or more scientific background? At what points could you add some additional materials to better support the protocol? Where are trial staff making notes, asking questions, or providing key pieces of implementation feedback?

Some things we’ve seen work well in other clinical trials:

Videos presented by research or development team.

Video is also extremely powerful for keeping someone engaged. Today, you can quickly produce a video using a variety of tools. For example,  your medical director could record a 90 second talk using their iPhone on the importance of the study. Or use a personal Zoom meeting to combine a site training powerpoint, with voiceover, or even music to break up the viewing experience. 

Infographics and visual ways to present past phase results.

Charts, graphs, flowcharts, and simple images are all effective to engage people visually with concepts you’ve included already in written copy, and they can all be created by anyone with a computer and the Internet. 

The great thing about engaging people is that they’re more likely to retain the information you’re putting in front of them. A video or well-designed image will engrain a point into the staff member’s memory. 

Embedded quizzes or prompts to nudge participants at key points in the protocol.

It’s a common best practice to use real world scenarios or vignettes to drive critical thinking during learning activities. This also helps break up the learning experience.

If you’ve delivered a case study in a large group at an investigator meeting, you can easily transition that to digital exercise. Virtually, individuals must complete the activity, rather than sit as you walk through the entire story with limited interaction. Completing the activity themselves helps to attach meaning to the content you’ve provided them. That meaning is what prompts the recall of the concept in the field.

Make your vignettes complex, and make them as realistic as possible. And make them take a decision while thinking critically. Remember that you are equipping people that will have to deal with real patients and real risks during a clinical trial, and they may be without experienced clinical staff that would exist in a larger study center.

Distributed clinical teams need ongoing training and support. Plan for that.

We’ve mentioned the Forgetting Curve in previous posts. It’s well-documented that humans will forget 70% of what they learned in 24 hours. We retain information better when it’s repeated.

So it’s important to build a cadence of communication to re-emphasize points that need to be retained or remembered. But a cadence like this can help you in other ways.

There’s a trend of CRAs or trial managers sending out “newsletters” hoping to deliver best practices or updates. These can quickly become noise – and worse, vary in quality and accuracy.

In a decentralized clinical trial, there are many more people to remind, engage, and update. Establish a schedule, and centralize the execution for your dispersed personnel.

Our clients tell us that they use Ready to develop regular, ongoing communication streams with our Boosts feature. During a trial, these clients use the automated Boosts to deliver best practices that they discover from caregivers, updates to processes, and even amendments to the protocol. 

Embrace technologies that support asynchronous delivery and decentralized teams.

In losing the centralized study training models, you also avoid the struggles of coordinating calendars and travel with very busy people. Embrace the flexibility of asynchronous learning, that is – delivering your clinical trial content on-demand.

Decentralized teams may span geographies and time zones, and you could easily spend days or weeks trying to deliver various sessions to accommodate all. Instead, choose technology that lets you deploy once, and update centrally.

Asynchronous learning isn’t the same as a recorded video, that can fail to engage or deliver any measurable results. In fact, the opposite can be true.

We blog frequently about clinical trial readiness, and a large part of readiness is the ability to measure. That is, understanding how capable and confident personnel are with applying your content.

As we described previously, metrics are both available and important for clinical trial readiness, especially in a remote clinical trial.

For example, imagine your entire clinical trial team completes an online presentation covering your upcoming trial protocol. Do you present them with a quiz to test their recall of critical information?

If you do, some of the team might answer correctly because they have gained the knowledge and are ready to apply what they have learned in your trial. Others, however, may get through the test by guessing. Perhaps they all pass. 

If they do, are they all equally prepared to conduct your study or are you releasing under-prepared staff, patients, and caregivers into the field alongside others who are ready to make good decisions. Without measuring readiness, which is what we drive towards with Ready, you won’t know how risky this is until you run into trial delays and deviations, or worse. 

Ready by ArcheMedX makes decentralized clinical trial training scalable. 

There are still a lot of challenges for life science companies that want to deliver a decentralized clinical trial. Fortunately, there are some strategies that will deliver benefits to any clinical trial – and developing a scalable approach to educating clinical trial teams is one major opportunity.

The first thing you need is an approach, and clinical trial readiness is an ideal one. Learn more in the Definitive Guide to Clinical Trial Readiness.

Second, you need an on-demand delivery platform for learning at scale, and Ready by ArcheMedX is the only learning and insights platform designed to better equip clinical trial teams. Ready is an ideal tool as you work to adopt the decentralized clinical trial design, and you can get a demo today.

 

 

 

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