Author: Molly Bryant

An Honest Look at How Demanding Oncology Trials Have Become: Interview with Rebecca Setta of Oncosec

Rebecca Setta joins Kelly Ritch, EVP of Product and Clinical Research Solutions at ArcheMedX, to discuss effective management of sites and teams through arduous clinical trials.

Rebecca shares how she’s kept her team motivated and productive in spite of the added burdens imposed by the pandemic, and why she’s excited about the future of the industry.

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

Rebecca Setta

Rebecca Setta is an Associate Director at OncoSec whose 13 years of experience in clinical trials have given her the benefit of several different perspectives. Rebecca began her career on the vendor side, and her continuous pursuit of development and higher-level understanding led her to transition to the CRO space in 2015. Her role at OncoSec represents the natural evolution of a career shaped around an inherent desire for growth through further immersion in clinical trials.

In Rebecca’s years of experience at the project level, she consistently found building effective teams to be among the most rewarding elements of her work. She now brings that expertise to bear at the department level, where she can act as a mentor, shaping a team to build on her knowledge and experience.

Episode Highlights

  • How Rebecca helps her team avoid burnout in a grueling field
  • The common characteristics she saw across the sites that adapted best at the start of the pandemic
  • A crucial change in mindset that she’s encouraged in her CRAs
  • The COVID-inflicted adaptations she expects to persist post-pandemic
  • Why it’s important to partner with sites
  • The unexpected upside to the pandemic adjustments her sites have made
  • What really impresses her about the industry
  • How remote work and limited face time can impact morale, and one way she compensates for that
  • How the weighty context of oncology research can also translate to motivation
  • Why she is so excited about the future of the industry

Resources:

Oncosec
Find Oncosec on LinkedIn
Find Oncosec on Twitter
Conversations in Clinical Trial Readiness Interview Series

Got a Clinical Trial Startup Post-COVID? Plan to Tackle 3 Big Challenges

There are still a lot of challenges facing pharmaceuticals, med tech, and biotech companies that seek to begin a clinical trial post-COVID. But the obstacles aren’t stopping them. At time of writing, over 500 companies have a Phase II or Phase III clinical trial startup planned in the next 12 months. Clinical research moves on, as it must.

If you’re planning a clinical trial, you already recognize some major differences from past studies. And the emergence of new trial designs like decentralized clinical trials and hybrid trials provide new opportunities – and obstacles of their own. 

However, regardless of your clinical trial design, there are three major differences every clinical operations leader needs to expect. Here’s a discussion of each one – along with some ideas of how to tackle them.

First, remember that it’s anything but “business as usual” for your clinical trial sites.

You feel the challenges of the ongoing pandemic, don’t you? Remember that many of the site staff are frontline healthcare workers. Their challenging day jobs are exacerbated by everything you’re feeling.

And you may worry about loading up already stretched site staff. There’s a lot they have to do before they even enroll the first patient: study startup training, initiation, and activation activities.

But with the availability of new digital and remote enabled tools, you can actually use the clinical trial startup to reduce site burden.

 

Reduce site burden by accommodating their busy schedules.

No, I don’t mean running web meetings every hour on the hour. Instead, think asynchronously. That is – make your protocol and clinical trial content available on-demand, instead of on your schedule.

On-demand start-up activities, such as site training, ease the load of the all-day meeting for site staff.  It also accelerates enrollment, because staff can begin preparing to screen patients as soon as your on-demand training is available. No more waiting for schedules to align for a group meeting or visit.

Using more advanced tools (like Ready) to deliver interactive training also enables you to collect valuable data immediately.  This data can then inform faster operational decisions (i.e., prioritizing site activation and monitoring coverage) based on real-time insights into site and staff readiness.  One of our largest clients, PRA Health Sciences values this quick access to data and actionable insights.

In fact, in equipping their own CRAs, PRA’s leadership uses Ready to deploy more interactive content globally. They can quickly determine which of their CRA team members are ready for a specific trial, and which ones need more preparation. This lets them intervene early to increase the capabilities of their teams where needed. You can do the same with site staff, or even your CRO’s team members.

Reduce site burden by consolidating their clinical study startup resources in a single hub, available anytime.

When you provide site training and activities in an on-demand environment, you get to avoid sending multiple files, portals, or emails stuffed with attachments. 

Centralize your study startup content into a single portal, or learning experience. And cut the extraneous noise of extra emails.

Tools like Ready make it so easy for you to build your site training around your existing protocol and essential study documents. Instead of wasting time converting each document into a slide deck, and then trying to deliver individual training sessions for each site, a far more useful exercise is to utilize a platform like Ready to turn that essential document into an on-demand and highly engaging learning experience.

Best of all you can do this in hours, not days and weeks. This saves valuable time (and possibly many hours of billable CRO time), and helps to drive consistency in your content. As we suggested in a recent article, you can re-invest some of the saved time by pulling together complementary resources, or improving your assessments.

And packaging all of your resources into a focused learning experience makes it easy for you to update, enhance, and deploy the same quality of learning to everyone even if they join a site part-way through a trial. Even better, it simplifies the lives of your site staff. It helps them to know where to go for everything related to your protocol, SOPs, and best practices.

Second, the reasons you had for using the same sites for every study startup are not as compelling now.

There’s really no good reason to only stick with “tried and true” sites post-pandemic. In a recent interview with Liz Beatty, the Chief Strategy Officer of Inato, she revealed that 70% of clinical trials are performed by the same 5% of trial sites.

And is there a great reason for that? Despite the belief that tried and true sites should be reliable to enroll and perform, there has been no marked improvement in the performance of clinical trial sites over recent history. In fact, Tufts reported that the clinical period has gotten longer.

It’s an ideal time to disrupt your model for activating sites for two major reasons.

Getting onsite is difficult today, so location isn’t as critical.

While it’s difficult to get onsite today, it is, and has always been, a burden to your sites when you’re there. In the push to reduce site burden, now is the time to reduce your reliance on in-person visits. Without that barrier, your site options expand greatly.

Is it now possible for you to consider sites that may be in regions that offer more diversity? Or perhaps areas with a less experienced but highly motivated investigator who has an available patient population…but hasn’t worked with you before?

The opportunity to expand to new sites and untapped patient populations has never been greater. Plus, over the past two years it has become evident that not only is diversity in your patient demographics needed, but it will be expected. Investors, partners, regulators, and the entire industry are expecting clinical trial leaders to learn and to change how they research treatments across ethnicities, cultures, lifestyles, and ages.

There are ways for you to objectively measure site readiness early in the clinical trial startup.

A site’s experience with you, your CRO, or any past clinical trial doesn’t tell the full story about its ability to perform in your upcoming trial. Site staff change, patient populations shift, sites may be enrolling competing studies. Solutions like Ready can reveal the critical insights you need to know about a site and its staff capabilities as they currently exist.

  • Want to see their confidence in enrolling the right patients quickly? Easily done.
  • Need to understand staff knowledge around handling and administering your investigational product? A snap.
  • Think it’s important to assess a site’s understanding of decision-making on exclusion criteria? Yep, that’s easy, too.

With objective and immediate readiness analysis available across all sites, both new and old, there is no need to guess about which sites can perform. You can have the same level of confidence whether you’ve worked with a site a dozen times, or never before. And – likely slash the risk of missing enrollment targets.

 

Third, the big in-person investigator meeting is not only off the table, it may be gone for good. 

OK, it’s probably not gone for every clinical trial for good. But depending on your specific objectives, you may not need it. And if that’s the case, you’ll greatly reduce your costs and workload. Plus, you’ll avoid the burden of scheduling a lot of very busy people away for hours or even days more than necessary.

One emerging biotech we work with has reimagined the PI meeting completely. This biotech instead chose to use Ready to deploy all of their PI meeting content completely online and completely on-demand. That means, similar to site training, investigators and study coordinators can begin consuming the protocol as soon as it’s deployed by the biotech. And that means the trial team can immediately discover insights about investigator readiness, too.

Just as you adjust your clinical trial startup, your trial team will adjust, too.

Fortunately, we humans are natural innovators, and natural adapters. You’ve already had to make major changes, and your sites, teams, and patients are making changes too, too. 

But when you’re not there in-person with your clinical trial resources, it’s easy to lose sight of the opportunities you have to help them adjust to your changes. 

Take the ongoing uncertainty in our environment as an opportunity to change. Don’t just do it for your next trial, but establish new and better processes to pave a path for running higher performing trials. For 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. 

New digital tools and predictive models will make this shift much easier, and can also deliver benefits to the rest of your team. But you must recognize these three challenges, and plan for them. Ready by ArcheMedX can help you improve your clinical trial startup, while you simultaneously improve your site and team performance (and ease their workload, too).

 

 

 

Decentralized, virtual, or hybrid clinical trial – what’s the difference?

Increased diversity. Faster enrollment. Reduction in costs. These are just a few of the myriad benefits of the virtual clinical trial touted by CROs and solution providers. But are you ready for a truly virtual clinical trial? If not, is a hybrid clinical trial realistic? And what is a decentralized clinical trial – how is it different? 

There’s no doubt that these and many other benefits are possible results, and even likely ones. If you’ve ever wondered how to even get started with one of these promising new trial designs, read on for our introductory primer. 

First, why are there so many new clinical trial designs?

It may feel confusing why the industry is using so many different terms to discuss what seems like one main idea: shifting many of the traditional in-person activities in a clinical trial to digital or virtual ones.

But two things are at play.

First, it’s not one main idea that’s up for discussion. The push towards virtual, hybrid, decentralized, and siteless clinical trials stems from a lot of challenges that plague clinical research:

  • Difficulty in reaching patient populations that don’t live close to existing study centers
  • Skyrocketing costs of clinical research (much of it in site costs)
  • Manual data collection despite availability of new technology
  • High early termination and/or discontinuation rates because of perceived burden

I could go on, as there are many more challenges. 

But the second factor is the obvious fact that COVID-19 all but halted most in-person activity in 2020. Thus, we pressed forward with innovations. Because the industry accelerated so quickly, we just haven’t had the time or maturity to settle on one concept.

What we’ll uncover in this post is that each of these terms actually are three discrete concepts. Though different, they each present a need for clinical operations leaders to find new ways to train caregivers and study participants in new ways and at scale – so that they will be ready to perform in their now virtual role.

So let’s dig into each of the predominant trial designs. And more importantly, see what they mean for you.

So, what is a Virtual Clinical Trial?

Let’s get this part out of the way: there is no “industry-accepted” definition of what a virtual clinical trial is. 

Very broadly, you see the term used to describe clinical trials that replace much – or all – of the in-person clinical trial activities with similar activities conducted through software tools, wearable technology, or some other digital means. 

The FDA hasn’t released a clear definition, either. But it was the FDA’s guidance at the beginning of the COVID-19 outbreak that really launched the topic to a trend.

Want to try the free learning activity that covers the FDA’s guidance? Click here.

But with limited clear direction, we now see confusion about the multiple terms used, and what they mean. 

How much technology must be used for a clinical trial to be considered a virtual clinical trial?

The most strict definition: A fully virtual clinical trial.

The strictest interpretation of the term is also the easiest to classify. A fully virtual clinical trial is one that is completely technology-based. That means there are no traditional sites, no physical locations used, and no face-to-face interactions. 

In short, everything is completely virtual:

  • Study start up – no face-to-face meetings, no site visits
  • Patient enrollment – completely digital
  • Patient treatment – no clinic visits, all done remotely
  • Data collection – fully automated via phones, apps, watches, and e-diaries
  • Testing, imaging, outcomes – are all digital touchpoints

All clinical trial activities are managed centrally. While interesting, this trial design poses some major challenges because of the availability of – or familiarity with – the necessary technologies. And availability of wearable tech, though on the rise, may be an accessibility concern for some populations.

And in this interpretation, there is no patient and caregiver interaction – only data movement. This creates an additional obstacle for the already difficult recruitment and enrollment process. The perceived benefit of additional, or more personal care drives some participants to join a study.

Further, some demographics could feel uncomfortable with the lack of caregiver contact. And we can’t discount the importance of the personal relationships that frontline caregivers provide to patients. Without them, retention could also decline. 

But as noted in a recent ClinicalLeader article, there’s some disagreement in the market about that point. Does a virtual trial mean that patients and caregivers can still interact, albeit virtually? Or does it preclude participant and caregiver interaction altogether?

The most realistic definition: Nearly all trials today are at least partly virtual clinical trials, because they are technology-enabled.

The broadest interpretation of the term virtual clinical trial, though not accepted, is what reflects reality today. Technology enables or assists most – if not all – clinical trials today. It often replaces what was once an interaction between a study participant and a caregiver.

And when someone talks about a virtual clinical trial,  it’s often the more realistic definition. While there are some who are pushing for the fully digital, no-interaction trial, most CROs use the term “virtual clinical trial” interchangeably with something else – the “decentralized clinical trial.”

So then what is a Decentralized Clinical Trial?

Helpfully, the FDA has given more guidance on the topic of the decentralized clinical trial.

By the FDA’s definition, it’s the operations of a clinical trial that are being decentralized, using technology to communicate with study participants and to collect data. 

While decentralized clinical trials are also virtual by necessity, the model centers on removing the burden of travel placed on patients.

Decentralized clinical trials shift the locus of the research.

It’s well-documented that most patients don’t live near a traditional research site. Decentralized clinical trials move the research out of the central study center and closer to those patients. That could be their homes, or their local community’s doctor’s office.

Though all the activities of a decentralized clinical trial are conducted remotely, and away from central study sites, they don’t have to be fully virtual.

In fact, by partnering with community doctors and even mobile health networks, caregivers are able to perform patient treatments in person. Doing so, however, still requires the support of virtual technologies, like:

  • Remote learning on the clinical trial protocol for practitioners and caregivers.
  • Digital transmission of data and collected outcomes.
  • Virtualization of patient enrollment and other processes.

The greatest benefit of decentralized clinical trials is reducing the burden of the patient. That opens up great opportunity for diversifying patient participant and caregiver populations across race, culture, language, and regional barriers that exist.

Decentralization introduces new obstacles.

But even with a highly-engaged patient population, and with the best virtual plan, some obstacles remain:

  • Decentralized clinical trials are not ideal for every clinical protocol, especially those that require specialized treatment or testing.
  • They also require education-at-scale for any caregiver or practitioner that will service patients during the trial. Without a plan for asynchronous learning and automated communications, this stretches resources.
  • Management of patients and investigational product has to be planned well to ensure adherence.
  • Data has to be collected in a way that is both reliable and scalable. Decentralization means that clinical operations must expand and simplify data collection to allow many more entry points, by more individuals – some of whom may lack experience, or be doing so for the first time.  

But now is a great time for trial sponsors to find solutions to these challenges. Telemedicine services, the acceptance of consumer-grade wearable sensors as reliable, new providers of mobile lab services and IP delivery, and on-demand learning tools like Ready for training-at-scale mean decentralization is more realistic than ever.

Get a demo of Ready, the only learning and analytics platform designed to improve performance and enable digital clinical trials.

With the right structure and a well-thought out plan, a decentralized clinical trial becomes very attractive. Today, CROs compete to build centers of excellence, even if they lack experience to support the demand.

But are they realistic for your trial – today? It’s unlikely, but that is why yet a third term has entered the nomenclature: the hybrid clinical trial.

What is a Hybrid Clinical Trial?

If your upcoming clinical trial is simple, and doesn’t require any face-to-face visits, a virtual design may be ideal for you.

If your trial demands diverse patient populations, and you’re well-equipped to educate individual care providers to deliver your investigational product, you might strongly consider a decentralized trial design.

But what if you see some opportunity for your trial, but still need some central sites? Or still require at least one in-clinic visit because of procedures or special tests?

This is the most common scenario for upcoming trials today, and it’s why I led with the idea that we should consider nearly all clinical trials “partly virtual.” In the strictest sense, though, they’re known as “hybrid clinical trials.” 

Today’s hybrid clinical trial designs are part of the catalyst for technology adoption. That is:

Even the FDA appears to be open to the opportunities of the hybrid trial design. The organization included the study design in its RWE framework as early as 2018. And after the COVID-19 outbreak reached the US, it issued new guidance establishing its openness to new technology adoption to keep clinical research going in an unprecedented time.

Virtual vs. decentralized vs. hybrid?

So, what term should we use? In short, all of them.

Each trial design offers specific benefits and challenges to upcoming clinical trials today.

Some areas of clinical research are not ready for remote monitoring and full decentralization. Many trials have some nuance that renders them too complex to remove human supervision from the protocol.

Telemedicine, while on the rise, doesn’t drive the same confidence as a face-to-face visit for some patients – at least not yet. And it’s not suitable for all trials, because of potential reactions, adverse events, or sophisticated equipment necessary for monitoring.

For most clinical trials beginning today, only the hybrid clinical trial model describes a suitably flexible scenario that accommodates any level of technology enablement. Most – if not all – clinical trials today qualify as hybrid trials.

Your study protocols today can mix and match centralized and decentralized tools and processes based on your specific study objectives. For example:

While you build your capabilities to embrace a virtual future, take advantage of the tools available today. Many, like those above, can deliver immediate value to you regardless of how virtual or decentralized your next hybrid clinical trial may be.

What Do You Do When You Don’t Have Enough Clinical Trial Locations: Interview with Krystyna Kowalczyk of Oncobay

Krystyna Kowalczyk joins Kelly Ritch, EVP of Product and Clinical Research Solutions at ArcheMedX, to discuss innovation and leadership in oncology clinical trials.

The founder and CEO of OncoBay Clinical, Krystyna shares her efforts to break the mold when it comes to cancer research, and explores OncoBay’s “just in time” enrollment model and why investing up-front in site preparedness is critical to impacting clinical research.

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

Krystyna Kowalczyk

Krystyna Kowalczyk is the CEO and President of OncoBay Clinical. The boutique CRO is not the first company she’s founded. She began her career in drug-device combination work but soon made the move to the CRO side, where she saw plenty of potential for making a significant impact in the research space.

It was Krystyna’s clear-eyed assessment of the industry that drove her to found OncoBay Clinical. Determined to build a fresh, modern CRO worthy of the ever-evolving oncology field, Krystyna and her team embraced an innovative approach to how digital tools and predictive analytics could change the research paradigm.

The willingness to constantly evaluate and adapt is fundamental to their work advancing immuno-oncology research.

Episode Highlights

  • The three tenets of OncoBay’s approach to cutting-edge cancer research
  • How to prepare staff for the complexities of a 21st-century oncology trial
  • Why we need to evolve from serial to real-time data assessment 
  • OncoBay’s “just-in-time” enrollment model (and a touching success story)
  • Why investing up-front in site preparedness is critical to maximizing impact in research
  • How the just-in-time model can help address diversity challenges in enrollment
  • Why new technologies and methodologies often create discomfort, and what leaders can do about it
  • How you can make 1 + 1 equal 3 when you combine tools effectively
  • Why putting together the right team is both more challenging and more critical than putting together the technology
  • What Krystyna looks for when assessing potential team members 
  • Why she’s excited for the next generation of industry employees

Resources:

Oncobay
Find Oncobay on LinkedIn
Conversations in Clinical Trial Readiness Interview Series

When Seeking Diversity during Site Selection, Look Beyond Historical Data to Discover Untapped Patient Populations

Interview with Liz Beatty about site selection and diversityWe recently spoke with Liz Beatty, Chief Strategy Officer at Inato about how the company is disrupting the industry’s approach to site selection. The company is headquartered in Paris, France, with US operations based in New York City, NY. Here are some of the most interesting excerpts from our discussion:

ArcheMedX:

You spent the bulk of your career at Bristol Myers Squibb, one of the biggest names in pharmaceuticals, but you’re now at Inato, which is a small-but-exciting place to be. How did you get here?

Beatty:

Yes, I was in clinical operations at BMS for several years, and went on to lead the digital clinical trials team during my last few years there. We were really focused on how technology could improve the way we run our clinical trials, and specifically, how we could better serve patients. I strongly believe we need to do more to ensure patients have access to clinical trials and then support them through the process. I felt that the right technology could help achieve this.

When I started with that group, I could see that there was some incredibly interesting tech out there, but most of it wasn’t ready for use in clinical trials. To help expedite the process, we had an innovation team serving as a corporate incubator that tested the technology. Once it was ready for use in clinical trials, we would bring it into trials through our team.

When BMS closed the CT office, I knew I wanted to venture out to the tech sector and use my experience to help a small company getting started in the space. Through that process, I met Inato. They’re a very innovative team asking: “How can we use technology to get medicines to patients faster?” 

This was so aligned to my passion, I knew I wanted to help bring their vision to life. I joined as their Chief Strategy Officer, helping with the strategic roadmap, shaping the marketplace model, and ensuring that we can deliver on value.

ArcheMedX:

Inato’s marketplace model is very unique. Can you tell us a bit about the history?

Beatty:

Inato actually started in feasibility. They had a platform that digitized data collection for global sponsors. When I started, they were supporting nearly 50 feasibility studies. This was at the same time that data-driven site selection was becoming a key part of sponsor strategy. 

Inato was at the center of digitizing data, using new sources to help with decision making and accelerate feasibility. Because we were the intermediary, we would often receive questions  from sites who weren’t selected and wanted guidance. We began to truly hear the voice of the site, as they said to us, ”I don’t understand. We have these patients. I know we could do this study. What could we do next time to be selected?” 

There was no feedback loop. Because sponsors were only using data to make their selections, some of these sites just didn’t have enough historic data to stand out or make the cut. 

ArcheMedX:

We hear so often that site selection is based on – best case – historic data of what a site has done in the past – and worst case – a total guess. Is that what you saw?

Beatty:

So much of site selection is simply history and relationships. So many sites that had all the makings of a successful trial site were passed over because sponsors would go with sites that they’d worked with before and believed could succeed. There were so many intangible factors that went into site selection that many sites couldn’t break through. We saw a major imbalance.

We did some analysis on data from clinical trials that successfully went through site selection to find what percent of sites actually got selected. Sponsors were telling us that they “needed to move faster, needed to do things differently,” but they always selected the same sites. We found that the top 5% of sites were running 70% of trials. Our data proved this to us.

The sponsors kept picking the same sites and then were wondering why patient numbers per site were decreasing and competition was rising. It became very clear to us that there are sites with motivated physicians who know how to do the research that can’t even get the opportunity to participate. We created the marketplace model to change this dynamic and allow more sites to raise their hands and prove that they are right for a trial. 

Sites that go through the marketplace don’t go through the traditional feasibility. We let them self-identify the clinical trials that best fit them and their patients. Once their application has been vetted and approved by our team, we highlight those sites and their strengths to the sponsors conducting the research so they have a greater chance of being selected.

ArcheMedX:

As you know, the ArcheMedX team is passionate about using data during site selection and study startup to prove which sites are ready to perform in a trial. So it’s exciting to hear about Inato’s data model. Can you explain more about the insights you’re producing for sponsors?

Beatty:

There’s an underlying trust problem between sponsors and sites that needs to be addressed. When sites fill out a questionnaire, they may put in the number of patients they think they can enroll – but the sponsors don’t trust it. They may discount the numbers by default.

What we’re doing is approaching the sites with a challenge: “This trial is important to you and you say you’re a fit – now prove it.”

Using any tools – their EMR, their database, anything available – we ask them to use data to show the sponsor why they’re a good fit for the study. With this approach, the sites can prove they have the right patients, staff, and ability to run the trial. 

The sites are very savvy and know their patient populations. Our marketplace helps them use data to show their unique capabilities, their ability to diversify the patient population, and ultimately helps to build trust with the sponsor.

Diversity and inclusion is a major part of our platform. Not only can sites say they do well with cultural diversity and education, they can actually prove that they have a diverse patient population and the right approach to support them through the trial process. Diversity can come in the form of ethnicity, age, gender – the sites have this data and giving them a way to highlight it builds that trust.

ArcheMedX:

Diversity is a critical topic in the industry right now. You’ve been vocal in the market about what we need to be doing, and why the time is now. What has been the general response from sponsors and sites? 

Beatty:

The industry knows it’s a problem, and I’m proud to say the industry is now ready to do something about it. I’ve seen feedback from the FDA stating that trials need to be diversified to ensure the clinical dataset is representative of the disease. In some cases, they’re even requiring companies to put warnings on products.

We’ve reached a point culturally where we must change. I am incredibly proud to be collaborating with other leaders on this because it’s going to take all of us coming together to change how we run our trials. We need to rely on the community-level perspective of sites to know if the area has the right populations and, more importantly, if the clinic has the resources and community outreach necessary to support those populations. Together, we can create a future where no one has to take a chance on a treatment because your background wasn’t well represented in the trial.

ArcheMedX:

This is a topic that our EVP, Kelly Ritch, is very passionate about: that for an industry so steeped in facts and accuracy, we rely so heavily on guessing in clinical trials

Beatty:

You’re right – unless a sponsor is getting the data from its site partners, they may not have the right information. Census data from where a site is located may say that a site has diverse populations, but it doesn’t reveal if the site actually sees those patients or is properly set up to support those patients. 

If the site doesn’t speak Spanish, for example, to effectively communicate and build that level of trust in the Latinx community, they’re not going to enroll this demographic into the trial. If the site doesn’t have the right staff diversity to support the community, if they’re not doing enough community outreach in an authentic way, they’re not going to enroll diverse populations. There are so many barriers. This is why sponsors need to connect directly with sites so they can see the full picture.

ArcheMedX:

This brings us back to the diversity badges you mentioned. Tell us more about the diversity initiatives and Inato’s badging process.

Beatty:

We went out broadly and spoke with industry leaders to ask about the key characteristics of a site that is successful with diversity in clinical trials. We then built our process based on the tenets that were well documented cross-industry. 

What we heard is that sites who do these initiatives well love to talk about it. They are extremely proud to share their data and approach. But we also heard concerns from sites that they didn’t want it viewed as a negative if they weren’t in a diverse area or didn’t have diverse patient populations in their community.

We introduced the badge model to make diversity a positive achievement, rather than a score. Sites can get a bronze, silver, or gold medal in diversity to highlight the work they’ve done and offer a path to improvement. Getting a medal is a positive thing, but not everyone gets one. The sites really helped us shape that.

We launched this diversity assessment in September of 2020, and nearly 100 sites have completed it. They’re incredibly proud, and because we listened to the sites, it’s been well received. From a data perspective, it’s site-reported, but we ask them to provide the proof. They have to pull from their database directly rather than rely on the census data. It’s site specific. The same goes for their staff – does it match the community they serve? Do they speak the necessary languages? Are they doing the right outreach? We ask them to prove it. 

We’ve made an effort to ensure we’re creating value for both sides of the marketplace. We spent a lot of time thinking about how we can improve things for the sites. Where can we remove burden from the site? How can we remove redundancies and make things easier for them? We want them to find the trials that are right for them, but it’s equally important to give them the support they need to be successful once they’re in the trial. 

ArcheMedX:

How do you think a focus on diversity affects other measures of site performance in a trial? 

Beatty:

This can be a really important differentiator for sites. For those who are good at diversity and inclusion in clinical trials, it should help them to stand out and be selected. 

Most of the sites that do well at this want our help changing how recruitment has been done in the past. Recruitment budgets by trial don’t work for diversity – community engagement isn’t study-specific. Sites need help with funding, budget, and staff for outreach. Can sponsors find new ways to partner with sites for this? We’re starting to get some really innovative thinking from sites who are good at diversity that should be explored. 

What we’ve seen from the sites who are active in their communities is that their patients stay in the trials. If the site has done a good job in supporting the community through its staff and speaking the community’s languages, their patients will stay in the trial. Those existing relationships help a lot with retention. By leveraging community sites more, people don’t have to travel far distances and meet with a doctor and staff they don’t know to participate in trials. Working with these community sites who have already established trust will allow sponsors to reach the patient populations they need to increase diversity in their trials.

ArcheMedX:

The next six months are a little hazy, but what can Sponsors do right now to improve on diversity in site selection?

Beatty:

I absolutely believe sponsors need to diversify their site supply. We have a problem with clinical trial competition. If we want to make an impact on the diversity of patients, we need to diversify our sites. Sponsors need to look beyond data sets and think broadly about who they need to include in their clinical trial programs.

Similarly, CROs need to be willing to work with new sites and their staff to deliver new medicines to patients faster. 

ArcheMedX:

Inato’s marketplace is truly an accelerator for clinical trial site selection, and is providing an unprecedented opportunity to sponsors to identify sites in untapped patient populations. The patient population insights provided by the Inato marketplace are an innovative measure that can change how clinical trials recruit. 

Sponsors and CROs who endeavor to forge new site relationships can do so with confidence by equipping all trial sites and their staff to succeed with Ready by ArcheMedX.

Attending Outsourcing in Clinical Trials West 2021? Join ArcheMedX There!

Along with most major clinical operations conferences, the Outsourcing in Clinical Trials event series is virtual in 2021.

The ArcheMedX team is excited to exhibit – as we join some of the foremost thought leaders at the leading clinical outsourcing and operations conference on the West Coast.

ArcheMedX team members will be available during the event, which takes place 24-25 February, to provide demos of our Ready product, the clinical trials learning platform designed to better equip Sponsors and CROs.

We will cover use cases that include:

You can join us at the event for an overview, or request a demo any time.

The 2021 Outsourcing in Clinical Trials West event has four focused tracks, covering Clinical Operations & Outsourcing, Medical Device Trials, Technology & Innovation, and Patient Engagement.

We also look forward to the scheduled panel discussions that will cover trends in patient engagement, the latest outsourcing strategies, and how to create a clinical trial landscape that makes technology and innovation more accessible to smaller companies.

COVID-19 has greatly impacted our world, and our industry in particular, and so the second day of the Outsourcing in Clinical Trials West conference is billed to address how to effectively run medical device trials at a local and global level in these unique circumstances.

Since many medical device companies are classed as small and mid-sized trial sponsors, this track will be especially valuable. The event has scheduled keynote addresses and sessions on relevant regulations, digital technology, innovation and COVID-19 responses for this day.

We’ll also be available within the conference site throughout the event for discussion on the latest trends in study startup, outsourcing in clinical trials, and other ways to improve performance and efficiency in clinical trials and clinical operations.

See you online!

Choosing a Solution to Train Clinical Trial Site Staff Virtually? Start With this Checklist.

Choosing the right way to train clinical trial staff is complex and exhausting under normal circumstances. Today’s immense pressure to accommodate new virtual working styles across investigator meetings, site selection, and site initiation visits magnifies those challenges. As we revealed in our recent report, clinical operations leaders are adopting virtual tools everywhere they can so they can more quickly restart clinical studies. And in our recent report, COVID-19’s Impact on Clinical Operations, we discovered that the industry has a few major focus points for study start-up:
  • To virtualize everything possible
  • To better understand clinical trial site readiness
  • To specifically transition site selection, investigator meetings, and site initiation visits to virtual models
With those changes in mind, you need to be thinking about how you will transition all the training initiatives that are part of study start-up from on-site to remote. You’ll likely need to invest in technology to do this, but any software project can be confusing and difficult.  To make it easier for you, we’ve put together a comprehensive checklist so you can choose the right platform for your studies. Download it here.
Want the checklist in printable form? Download it here.

Choosing a solution to equip and train clinical trial site staff? Here’s what you’ll find on this checklist.

But now you need the technology to do just that – so check out this detailed checklist to help ease your load in the selection process. What you’ll find in this article:

Why choosing the right solution matters for your clinical trials

Outlining the outcomes your clinical trial solution must deliver

Defining the learning objectives for your trial sites

Factors You Need to Consider in Choosing a Platform

Must Have Features for Clinical Trials

Understanding Pricing

Why choosing the right solution matters for your clinical trials

We know that the majority of the industry is planning to virtualize the clinical trial start-up stage. The reality is that trial start-up activities are primed for virtual delivery. Most of them will scale better, perform better, and deliver better actionable data for decision makers in a virtual model.  And if you virtualize these activities successfully, then you will be able to gain efficiencies, ensure continuity of messaging, and greatly reduce many of the start-up delays you commonly encounter. But when it comes to selecting a learning platform, you have to remember that it will impact these three things:
  • How quickly you can select the right trial sites.
  • How quickly you can verify they’re prepared to enroll subjects.
  • How quickly you can actually start enrolling patients.
Many eLearning solutions exist today, and most of them focus on just the surface-level actions that you need to perform, like uploading content and delivering it to viewers. But there’s much more at stake with your clinical trial.

1. Outline the Outcomes Your Clinical Trial Training Solution Must Deliver

The best solution for equipping your trial sites is the one that successfully delivers the outcomes and objectives that you need to make better decisions about site start-up. These outcomes must go far beyond being able to upload a protocol, add additional resources or files, and distribute the content quickly on-demand.  More importantly, think about the real business objectives you have for your trial staff and focus on the outcomes required to more effectively conduct the study. Some examples include:
  • Move beyond simply identifying who has completed your site training, and who has not. Insead, measure how well individuals and site teams demonstrated comprehension of the protocol and processes.
  • Evaluate individual confidence in making the right decisions.
  • Reveal the sites and teams that are best-equipped for starting your trial now.
  • Uncover sites and teams that may not be prepared – but could quickly become ready with additional support and remediation.
You can see that these objectives are much deeper than just training – they’re focused on achieving successful study start-up. Thinking about your needs in this way means you’re more likely to choose a training platform that will provide you with measurable results.

2. Define the Learning Objectives for Your Trial Sites

In addition to your desired outcomes, you need a clear list of which procedures your team and site staff should be capable of performing at the end of your training curriculum.  Your objective for your team may be to identify which sites are best prepared. Meanwhile, your objective for sites could be that they are prepared to succeed with the trial protocol. Some ideas on what to include in your learning objectives:
  • Site staff must demonstrate they fully understand the protocol and enrollment criteria.
  • Site staff need to demonstrate confidence in making decisions about patient eligibility.
  • Site staff need to prove that they can make the right decisions after the training.
Certainly you can add more, or be more specific. But make sure you establish these objectives because they will influence your feature needs. Need more information on planning the right objectives and content before you train your clinical trial site staff? Check out our blog 7 Tips to Transform Training Content for Use in Clinical Trials.

3. Factors You Need to Consider in Choosing a Platform to Train Clinical Trial Site Staff

Now that you’ve established your objectives, there are other factors that you need to consider — before you get to features and functionality.

Industry focus

Despite the fact that there are many tools available that can deliver content, they’re not all up for the challenge of serving a clinical trial team. There are many nuances that you need a partner to understand, including the global nature of sites, the complex nature of the content itself, and your specific business needs. Ideally, choose a tool from a company with deep experience in clinical operations that can provide use cases and references in your industry.

Delivery

Is the training platform an on-premise solution that you have to host somewhere, or a fully SaaS enabled model? Is it available on-demand for site staff at any time, or is it a live-only solution? Does it offer automated engagement tools to re-engage site staff over time?  Be sure you understand how both the learning platform and content are delivered to your learners so you don’t select a “live only” meeting tool when what you really needed was something that offered “on-demand” training for a global trial.

Support

When things go wrong, and something always does, be sure you understand the vendor’s support model. Be sure you know who to contact for what – and pay attention to how forthcoming the vendor is during the early stages of your relationship. Also, will you be responsible for updates and patches, or is the tool a true SaaS product that includes all technical support? Be sure you know what is your – vs. the vendor’s – responsibility.

Scalability

Many tools can provide training for a few hundred users in a single location, but you may need something more scalable. Make sure that you understand the ability for any training tool to cross borders, and support a global trial — if only for the future.

4. Must Have Features for Anything You Use to Train Clinical Trial Site Staff

Every learning platform has their own set of unique features and functions. But in order to successfully prepare your clinical trial site staff, you need to make sure the platform you select has these following features.

Flexible content support

Content is the foundation of your clinical trial team’s success, and thus of your training. Any other feature succeeds only if your content is consumed.  You need to be sure you understand that the platform will support everything that you need to guarantee a fully comprehensive site training! Make sure you ask these questions:
  • Can I upload my protocol directly, or do all trainings have to be delivered as video?
  • What content types are supported (like PDF, image files, audio files, etc.)?
  • Am I limited in the content size or number of files?
  • How easily can we add new content?
  • How easily can we update existing content?
  • Can I reuse content across trainings?
These are all important use cases for clinical trial site trainings – and you likely have others you’ll add for your specific trials.

Annotated learning

Besides the base content itself, you need to understand how you can enhance the site staff’s learning experience to point them to specific key objectives in the protocol. This ensures that new or unique requirements of the protocol or processes aren’t missed and that site staff focus on your key study objectives. Annotated learning is a critical part of training your sites well, so make sure you require this on your checklist, along with some clarifying questions like:
  • How easy is it to annotate a piece of content?
  • Can I link my annotations to specific study objectives? 
  • What types of annotations can I use (like including an additional resource, a quiz, or an immersive multimedia file)?
  • Can I control how the annotation is presented based on its relevance?
  • How do I measure and evaluate how a staff member interacts with the annotations?

User behavior tracking

When we start to consider the types of reporting you need for your objectives, it’s wise to start with the basics. User tracking data is great for monitoring as a clinical operations leader.  It lets you gauge the learning tendency of the site staff. It also helps you check the amount of time they spend on a particular lesson or the number of attempts made for passing any assessments.

Assessment 

You absolutely must ensure you will receive the right insights on the performance of the site staff from your tool. Many training platforms are designed for very general use – where completion is straightforward. Often, in these tools assessments are limited to multiple choice. But for the demands of a clinical operations team, you need more. Remember that your main objective is to train the site staff so you can select and initiate the most ready sites. So ensure that your training platform offers more than just a “quiz” to validate their readiness. Add these questions to your checklist:
  • What types of assessments can we use in gauging trial site staff knowledge?
  • Do you offer confidence based assessment as a standard feature?
  • How can we design and adapt assessments to meet different training objectives?
  • Can we allow team members to “test out” if they’ve previously proven their knowledge? 
  • If test out is allowed, how much control do you have in setting the right thresholds?
  • What metrics do you incorporate in assessing site staff, and can we configure some of them?
The assessment functionality is critical to you achieving the objectives that you set out at the beginning of the checklist. Make sure you get the full story.  Want some additional ideas on assessment and metrics for clinical site teams? Check out our recent blog on 3 Metrics You Need to Add to Your Clinical Trial Site Selection Checklist.

Readiness scoring

The training platform’s approach to enabling clinical trial site readiness comes last, but it’s the most important for your purposes.  Ensuring that individuals and sites are sufficiently prepared (i.e., ready) to conduct your clinical studies is an essential part of keeping the many people who participate in clinical trials safe while ensuring the trial runs smoothly, remains in compliance, and stays within budget. The key to improving trial outcomes is having training strategies in place to improve trial readiness by effectively assessing and rapidly identifying those individuals and sites that will be high performers and those that may require additional training and support. So, make sure that your training solution is equipped to help you employ this critical part of assessing trial sites and team members. Ask your vendors how you can uncover these details about sites:
  • Which sites are demonstrating readiness and likely to succeed
  • Which sites are most likely to struggle and why
  • Which individuals do not fully understand the study’s key objectives
  • Which study objectives and key subject areas are misunderstood
  • Which personnel are likely to perform well and against which objectives. Can these people be strategically placed to mitigate a point of risk, or to tend to a high-value item?

5. Understanding Pricing

Your budget is always a major consideration, and every software product out there seems to have a different pricing model. The pricing model for a training solution may vary from vendor to vendor. Make sure you understand the entire cost of the project, as well as when fees might come into play.   Because there are so many pricing models, it’s very difficult to compare vendors on price alone. So instead, make sure you ask these budget questions to get the full pricing picture:
  • How is the product licensed? Per user, per site, per learning activity, one-time cost?
  • Are there hosting/support costs in addition to the license?
  • Are there additional annual costs associated with the software?
  • Are there implementation costs, like installation or setup fees?
  • Are there additional costs to activate new sites or add new staff?
  • Is there a threshold on content or on the number of trainings?
  • Will we need to purchase additional hardware or software to make the training platform work?

Remember that the right clinical trials solution for you is the one that meets your objectives

The great thing about having a checklist is that you control what items must be checked off, and what items are simply window dressing. When you need to train clinical trial site staff, though, you have to remember your primary objective is getting the trial started with the best equipped group of sites. Not every learning tool is up for the challenge, or specialized enough to give you the right insight you need. Want to download a copy of this checklist for your own use in choosing a solution to train clinical trial site staff? Get the PDF copy here.

Helping Sites and Teams Make the Shift to Decentralized Trials: Interview with Paul Evans of Velocity Clinical Research

Paul Evans of Velocity Clinical Research talks with Kelly Ritch, EVP of Product and Clinical Research Solutions, to discuss best practices for sites making the shift toward decentralized trials.

Paul shares how his own organization was able to pivot so quickly when the pandemic hit, why it’s too early to make the call on whether virtual will be cost saving, and how he pictures the future of his 12 (and counting) sites.

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

Paul Evans

Paul Evans is the President and CEO of Velocity Clinical Research. In his nearly 30 years of industry experience, Paul has both run sites and managed them.

He’s worked for some of the world’s largest CROs, but he returned to the sites business because that’s where he believes there’s the most potential for positive impact on clinical research.

Paul’s primary aim at Velocity is to tackle the one clinical research problem that’s been a constant throughout his career: patient recruitment.

Episode Highlights

  • How Velocity adapted when the pandemic hit, and what they prioritized to act promptly and effectively.
  • Why brick-and-mortar and virtual constitute a continuum, not a dichotomy.
  • What teams need to do to be successful transitioning to virtual.
  • Why remote monitoring still poses a challenge.
  • Why tech isn’t always optimized for the site side.
  • How remote improves patient engagement and retention.
  • Why the clinical research coordinator role is changing, right down to the essential skillsets.
  • What we need to do to make sure site coordinators are comfortable enough to be effective with the tech they need to adopt.
  • Why we’re probably a long way from seeing virtual as a money-saver, and what will need to change to make it cost-effective.
  • How lessons learned in the late 90’s can be an instructive cautionary tale today.

Resources:

Velocity Clinical Research
Paul Evans on LinkedIn
Conversations in Clinical Trial Readiness Interview Series

The Evolving Role of Sites in Virtual & Decentralized Trials: Interview with Mary Costello of Medable

Mary Costello talks with Kelly Ritch, EVP of Product and Clinical Research Solutions, about how clinical research site management is changing – and marching towards sites being capable with decentralized clinical trials – in the face of the pandemic.

Mary’s more than 20 years of diverse experience in the industry position her well to provide insight from a variety of perspectives, including management, marketing, and the coordinator’s role.

She shares the new cornerstones of success that have emerged in the face of COVID, and illuminates ways we can all work together to help research sites deliver.

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

Mary Costello

Mary Costello is the Head of Site and Investigator Network at Medable. In her role she works to ensure that the site’s perspective helps to inform development.

Prior to joining Medable, Mary worked in software, clinical research, and marketing at diverse organizations, including Covance, Thermo Fisher Scientific, and eClinical Solutions.

She brings to the table a strong appreciation for the value of the stakeholders’ experience, and is pleased to be working with a female founder for the first time in her career.

Episode Highlights

  • How excellence in site management has changed since the pandemic.
  • Why the sites are still the lynchpin.
  • Why anxiety around decentralized clinical trials is misplaced.
  • How a marketing perspective can serve clinical operations and site management.
  • What sets sites apart that will succeed and sites that will struggle in this new landscape.
  • Why it’s important to assess a site’s tech-readiness and physical situation before handing down directions on how a study will be run.
  • Simply providing a site with technology isn’t enough, so what else needs to be done?
  • Why prevention and preparation beat correction and remediation.
  • How to maximize collected data through follow-up and implementation.

Resources:

Medable
Mary Costello on LinkedIn
Conversations in Clinical Trial Readiness Interview Series