Author: Molly Bryant

Guessing could be adding 7 months of clinical trial delays. Here’s how to stop.

Getting new treatments approved has never been harder, but recent research reveals that the regulatory agency has also never been faster. So why is it getting more expensive and taking ever longer to bring a treatment to market? Three words: Clinical trial delays. 

It’s taking longer to bring a treatment to market, and clinical trial delays are partly to blame.

A recent study by Tufts Center for the Study of Drug Development revealed some shocking news: the clinical development of new drugs is lengthening, and not by days, but by months. This, despite regulatory approval time for new drugs in the United States shortening.

The actual numbers? 

Average clinical phase time increased by nearly seven months. Approval times dropped during the same time by nearly two months. In total, the time to conduct clinical studies and then complete the approval phase increased by 4.8 months.

This is a worrisome trend, worsened by our current environment fraught with delays due to COVID-19. So why is it happening?

Like any question in clinical research, the answer is complicated. However, we can point to a few truths:

  • Despite approval times reducing, regulatory agencies are keen for sponsors to include longer follow-up phases.
  • The treatments and associated trial designs continue to become more complex.
  • Delays continue to plague all phases of clinical trials.

Only the clinical trial delays are within your control as a sponsor or contract research organization (CRO). It’s well-documented that 85% of trials will experience a delay, so reducing delays is a worthy undertaking.

Let’s take a look at three places where you can – and should – stop guessing: investigator meetings, clinical trial site initiation, and clinical trial site problems.

1. Stop guessing about your investigator meetings.

When planning an investigator meeting agenda, many make assumptions about what the investigators know, and what they don’t know. We guess about what content they will find challenging and what they will find easy. And we guess about where they are going to need help. We guess…quite a bit.

Why? There are so many ways to surface what the attendees actually already understand today. We can use digital survey tools, through pre-assessments, or online knowledge analysis. 

There’s no reason to play this guessing game today and waste valuable time during the meeting. That wasted time could be spent emphasizing the critical topics that the investigators and study coordinators really need to know better. 

Better-prepared investigators and study coordinators will beget better-prepared clinical trial sites. Those sites will be better able to enroll and conduct your clinical trial, with fewer delays.

So how can we stop guessing? Some sponsors distribute a survey or ask for feedback after sharing a protocol synopsis. Others use a clinical trial solution like Ready to deliver a pre-meeting assessment or pre-meeting content. Doing so helps to understand attendees’ initial knowledge of and comfort with the planned study.

Investigator meeting content delivery will engage PIs and Study Coordinators around the content and critical questions ahead of time. This provides valuable insight to meeting planners and content developers. 

Want to go further? We recently covered how to deliver a fully virtual investigator meeting. A virtual investigator meeting will enable you to create a learning track that takes the same amount of time to develop, and much less cost to deliver. That’s because you can:

  • Prioritize content and topics based on pre-tests
  • Deliver the entire investigator meeting remotely and on-demand (reducing travel and meeting planning costs, and preventing delays at sites where the PI can not travel)
  • Prioritize follow-up content based on how the investigators and site staff perform in the training
  • Automatically send follow up content to re-emphasize critical points

Taking the guesswork out of creating your investigator meeting content, virtual or not, is a proactive step you can take to ensure that investigators and coordinators are prepared to operate at their highest level of performance. 

However, doing that alone is not going to eliminate clinical trial delays. Making your clinical trial site initiation process more accurate might.

2. Stop guessing in your clinical trial site initiation.

Many sponsors and CROs make decisions about which sites to initiate and when to initiate them using primary tools that are a bit outdated. Examples include: attendance records for investigators invited to the PI meeting, outdated historical site data, and site-provided data which could have dubious origins.

Sometimes, sites guess or inflate the number of patients that they believe they can enroll when completing the traditional site feasibility assessment. Sponsors and CROs anticipate this response and typically adjust the projections to fit their expectations for each site. 

So sites are guessing, and sponsors and CROs are responding to that with more guessing. And for an industry so focused on data endpoints and statistically relevant evidence, it’s shocking. This makes the frequency of delays in these clinical trials much more understandable. 

If you knew that removing the guesswork would reduce your clinical trial delays, wouldn’t you find a way to do so? 

More accuracy in clinical trial site initiation will reduce delays. And it is possible to achieve.

There is so much more accuracy available with digital clinical trial solutions today. As Kelly Ritch wrote previously: “We can leverage proven digital technologies and behavioral analysis to evaluate site feasibility in a more novel way that assesses the confidence, capability, and interest of site personnel.”

We can leverage proven digital technologies and behavioral analysis to evaluate site feasibility in a more novel way that assesses the confidence, capability, and interest of site personnel.

For example, combine your historical site data and performance with current, and specific, context to find the right-fit sites to initiate for any particular study. Measures can include the level of confidence and capability in this particular study’s area of focus for critical staff like the current study coordinator, the principal investigator and sub investigators. 

Or you could analyze these sites’ commitment to recruiting subjects for your study vs. their existing studies. 

You don’t have to restrict yourself to data that the site provides. Using a clinical trial solution like Ready, you could be delivering not only a remote investigator meeting, but a fully remote site analysis. Then you could determine which sites have both the historical performance and the current aptitude to succeed.

CROs and sponsors who do this deploy a remote interactive experience to prospective sites using the clinical trial protocol synopsis and key questions. As the site personnel engage with the content, the sponsors and CROs can measure their readiness and fit automatically. As a bonus, these sponsors and CROs are also gathering key inputs about the viability of the protocol first-hand.

The CROs and sponsors can quickly discover the site personnel strengths and weaknesses, their engagement levels, and how they rank vs. other potential sites.  This directly enables them to decide the order in which they should initiate sites to drive the best and highest quality enrollment.

Armed with this data, those trial teams know exactly which sites are most likely to succeed with the trial’s requirements. Even more exciting, they have new visibility into the risk areas for ill-prepared sites, and can stop guessing about site problems.

3. Stop guessing about the clinical trial site problems.

More than 1 in 3 clinical operations professionals struggle to know where and how best to help trial sites that aren’t ready to perform a trial. 

Most site problems fall into three categories:

  • Recruitment
  • Data and documentation
  • Protocol adherence

You probably have many SOPs and processes around addressing each of these. But why are you waiting to address them as they appear?

Some might suggest “additional clinical trial team training will reduce the downstream delays.” That may be true, but wouldn’t it be better, faster, and possibly cheaper to identify risk areas before you start with a clinical trial site? You may not have to push every site or staff member through additional training.

The best way to prevent clinical trial delays is to stop waiting, and be proactive. If you revert back to tip #2 – you reduce two different ways:

  • By starting your trial with sites that are less likely to experience problems
  • By identifying and remediating risk-prone sites before you start with them

Now, you can invest time and resources to upskill all or just some of those sites. Simultaneously, you can begin with limited delays from the best-equipped sites.

How does this work? 

As I described above, using a clinical trial solution like Ready, which is focused on not just training your clinical trial sites, but on predicting their performance, allows you to spot the high performing sites and those with gaps in knowledge or capability.

Better – you can uncover exactly what those gaps are. Then address them before a problem occurs.

Guess less, reduce clinical trial delays.

Sounds nice on paper, but shifting to a more data-centric approach to equipping your trial team requires thought and commitment.

We’ve created a thorough Definitive Guide to Clinical Trial Readiness, which can be a great next step for you as you focus on eliminating clinical trial delays.

Want more help? Take a demo of Ready, and see how you can be accelerating trial timelines with a comprehensive approach to clinical trial readiness.

ArcheMedX Promotes Kelly Ritch to Executive Vice President of Product and Clinical Research Solutions

Charlottesville, VA — July 14, 2020

ArcheMedX leadership is pleased to announce the promotion of Kelly Ritch to EVP of Product and Clinical Research Solutions. Ritch joined in 2019 to support the increasing demand for Ready, the company’s clinical trials platform, with sponsors and CROs. 

“Kelly has already made an indelible impact on our team in the time she’s been at ArcheMedX, and we are thrilled to elevate her into a senior leadership role. She continues to demonstrate the mindset and elite leadership skills that we require in order to scale,” said Joel Selzer, CEO and co-founder.

Ritch is known as a dynamic and innovative executive adept at driving high-performance and long-term value through the applied use of software, data, and technology driven solutions for clinical research. Her operational expertise and strategic mindset has already enabled ArcheMedX to scale the capabilities it provides to multiple clients in the clinical operations space.

“It’s been an incredible experience working closely with clinical operations leaders so far to harness the predictive power ArcheMedX provides,” said Ritch. “I’ve seen first-hand the impact that more informed decisions and improved performance can have on clinical trial efficiency and outcomes.” 

Nearly every clinical trial encounters operational challenges and according to industry reports an estimated 85% of all clinical trials will experience delays, with 94% being delayed by over a month. These delays can have significant financial costs for each day that a trial impedes a product’s development and launch. 

With her promotion, Ms. Ritch will expand her oversight across product strategy and clinical research market development, as well as contribute more to the company’s thought leadership.

Before joining the ArcheMedX team, Ms. Ritch led clinical data management, sales and marketing, clinical trial operations, and strategic partnerships for 20+ years with both sponsors and CROs.  While creating and leading high-performance teams across clinical research functions, Ritch has had the opportunity to evaluate, implement, and develop a number of key software platforms used to support and improve clinical trial performance. Ms. Ritch has earned degrees from University of Virginia, University of North Carolina Chapel Hill, and University of Virginia Darden School of Business.

 

About ArcheMedX

ArcheMedX helps companies across the life sciences and healthcare industries to better equip, evaluate, and predict team and clinician performance, in order to accelerate the development and adoption of new clinical treatments and best practices.

ArcheMedX’s flagship product, Ready, predicts and improves how teams and clinicians will apply knowledge and skills in real-world scenarios. Ready uses behavioral science to enhance how individuals learn and retain information, and delivers actionable insights enabling leaders to identify high performers, potential risks, and areas for improvement. 

To learn more about our readiness solutions across clinical operations, commercial, and medical education, visit www.archemedx.com or follow ArcheMedX on LinkedIn.

Continue Reading

5 Places in Clinical Trials Where You Should Be Digital Now

Until the recent changes forced upon our industry by COVID-19, clinical research has been anything but digital: instead, relying heavily on in-person interaction, monitoring, and data collection. 

Many trials have been forced to halt, or change standard operating procedures (SOPs) in order to restart. The adoption of digital solutions has accelerated. But will these changes remain? 

With any change brought about by external forces, there is a risk that some will revert to traditional practices out of familiarity or perceived cost. But there is a huge opportunity to begin down the path of true digital transformation for your clinical teams if you stay the course. 

Here we’ll take a look at:

  • The benefits of sustained digital transformation
  • Investigator meetings
  • Site selection and site initiation
  • Site training
  • Ongoing onboarding
  • Patient data collection

What benefits will sustained digital transformation bring to clinical research?

When talking about digital transformation, most executives frame it in one of two ways: as a corporate mandate, or as a vision. Either approach, without action, rings hollow.

In order to push any change in an organization, identifying the business case is truly the first step. So what business outcomes can you expect for more deeply integrating digital solutions within your clinical research programs?

Reduce your costs with digital solutions in clinical research.

The most critical measurement of any business initiative is monetary. It’s also the easiest to quantify. Depending on where you inject a digital solution, the calculation here is easy. The problem is – it is a calculation. This distinction is important, because without calculating the savings that a digital solution provides, all you will see is added cost from licensing and implementation. 

For example, if you implement a solution like Ready for an upcoming trial, you should compare that cost to the prior expense of the in-person activities the solution enables you to eliminate, like:

  • Location rental/contract fees for large meetings you’ve moved to digital (like investigator meetings)
  • Site fees attached to in-person meetings you will no longer pay
  • Travel costs related to being onsite for all activities you’re replacing
  • Time saved by avoiding travel for every employee/team member involved

Producing this simple, yet critical, component of your business case will make it easy for you to say yes to continuing with any newly adopted digital solution.

Increase patient enrollment with digital solutions in clinical research.

It’s well documented that many trials fail to meet recruitment targets. You’ve seen the stats: As much as 86% of clinical trials do not reach recruitment targets within their specified time periods.

But what if you remove many of the most common barriers to recruitment? Remove burdensome things like travel time, or exposure to external environments (like the pandemic right now). 

Or what if you’re able to cast a wider net beyond your site locations by using digital solutions? 

Removing the difficulties that patients face, expanding your geographical reach, and making patient education available in a more digital, on-demand format? You may have adopted digital solutions to get through the pandemic for recruitment, monitoring, or patient education – but these are real impacts you can realize by keeping them.

Support diversity in patient recruitment with digital solutions in clinical trials.

Beyond increasing patient enrollment, patient diversity is another powerful outcome you can manifest by continuing with digital processes. By relying on brick-and-mortar site centricity, you limit your enrollment to patient populations who have access, and often who have convenient transportation. 

If your organization is committed to diversifying patient populations, then you have to shift to a digital approach. Most effective?  Focus on digital recruitment to reach more patients and physicians directly through the many tools and strategies available for outreach. Also prioritize education, and make informed consent more accessible through a digital content tool like Ready.

So where else will you see the biggest impacts in clinical research with digital adoption post-pandemic? 

Area #1: Investigator meetings 

Investigator meetings (IMs) are prime for disruption. With the average IM series price tag for a global Phase III study approaching upwards of $1 million, there’s a huge amount of cost involved. Could it be realistic to move these meetings – even just some of them – to a digital experience instead?

We performed a survey in the life sciences industry around clinical trials before and after COVID-19 completely changed our world. In that survey so far, 68% of respondents said that their organization believed investigator meetings had to be in person before COVID-19 struck.

But now? Only a paltry 15% today believe investigator meetings need to be in person. Even more compelling, more than 74% of respondents feel that investigator training could be just as effective or more so as a virtual event. 

More than 74% of life science professionals feel that investigator training could be just as effective or more so as a virtual event. 

It’s clear that the industry already sees investigator meetings as an area where digital is here to stay, and it’s probably because of these reasons:

  • Delivering the training virtually saves a huge amount of money (see the above $1 million stat).
  • IM planners can measure and assess the actual consumption and mastery of the meeting content when using a digital solution like Ready. Compare this to most in person meetings, where there is no assessment beyond a “present” check mark.
  • Even with delays to trial startup, trial teams can continue to review and reinforce their understanding of the protocol when it’s digital, on-demand, and (ideally) able to automatically prompt the team to re-engage. 

Area #2: Trial Site Selection and Site Initiation Visits

Yes, these are two different areas. But the differing approaches to site selection, along with the myriad of solutions available for site use and site initiation reveals some overlap in opportunities.

The larger the number of sites you need to manage, the more benefit you will receive by moving anything you can to a digital experience. In fact, 77% of our survey respondents indicate that they’re increasing their use of digital tools with regards to site selection. Similar to investigator meetings, by using digital tools, you increase your ability to more accurately assess consumption and mastery of your trial protocol and processes. So a virtual site selection could be a more accurate, and less time-consuming process.

Even more telling, 84% are increasing their use of digital for site initiation visits. So much of these visits can be moved online, especially for sites that are clearly ready to start. Whether you’re using web meetings to initiate, conference calls, or a full, comprehensive virtual onboarding with Ready or something else, site startup activities are a perfect place to continue with digital solutions.

84% of life science organizations are increasing their use of digital for site initiation visits.

Area #3: Clinical Trial Site Training

Really, any clinical operations area that involves the communication of information like the protocol, amendments, SOPs, or other essential documents is something that you should be moving to digital during this pandemic. Learning does not have to stop!

One of the greatest risks to virtual training, however, is distraction. More so than an in person training, care must be taken to engage learners, focus their attention, and reduce the risk they speed through the content, sharing answers to assessment questions, and multi-tasking. Here are some of the most important things that clients of Ready do to ensure success with this:

Area #4: Ongoing Team Onboarding and Training

When you joined your current team, what was your onboarding experience like? Was it guided, paced, and targeted to the particulars of your new environment? Or was it like you’d been dropped into the wild west and needed to find your way out?

Particularly for long-term studies, there will always be change in personnel and team members. So plan for it. Make your onboarding documents and process as digital as possible, and organize and prioritize your clinical tools and assets to simplify site and team personnel changes. Your new team members and your sites will thank you.

Area #5: Patient Data Collection via Wearables in Clinical Trials

With the vast adoption of wearables like smart watches and wristbands, there’s a low barrier to adoption for patients. Plus, wearable devices optimize data collection with their sensitivity and widely-tested calibration. Wearables are a fairly mature market, and it’s something we need to adopt more broadly in clinical research, as Kemi Olugemo, M.D. pointed out in a recent conversation with us.

Despite their low adoption in clinical trials, the current time is a perfect way to collect data remotely like walking speed, seizure detection, or perspiration, as examples. Performing diagnostic and biomarker data collection without subjecting trial participants to a visit is vital now, but prudent for a future where we emerge from the pandemic. 

Even more promising is the possibility of more accurate and consistent data capture can increase the power of your study. Could that mean fewer participants and accelerating the conduct? Very possible.

Make Digital Solutions a Long Term Focus for Your Clinical Trials

It remains to be seen how much digital change will result in true transformation for our industry. But we know that the steps we take now can pave the way for trials that are less expensive, more accurate, more accessible, and more timely. 

Ready by ArcheMedX can help in many of the areas discussed in this blog. So the question is – will your trial team be part of the change now? If so, let us help.

Interview: Adopting Consumer Tech in Clinical Trials Will Pave the Way for Hybrid and Virtual Trials

Kemi Olugemo, M.D.

We recently spoke with Kemi Olugemo, M.D., Executive Medical Director, Neurology Clinical Development at Akcea Therapeutics. Akcea is a development and commercialization company focused on helping patients with serious diseases. The company is based in Boston, MA. Here are some of the most interesting excerpts from our discussion:

ArcheMedX:

You’re a neurologist by background, and spent a number of years in patient care. How did your journey bring you to research?

Olugemo:

During my neurology residency training, I developed a keen interest in Multiple Sclerosis (MS) and its treatment evolution. This led me to subspecialty training in neuroimmunology and MS.

I was lucky to have exposure to several clinical trials as an MS Fellow. At that time, MS therapies consisted of mostly injecticable options. These options at that time represented a significant improvement in quality of life for MS patients. Over the ensuing years, I could see that the treatment landscape was really evolving, and I found it incredibly exciting.

Although I spent the initial 4 years of my career focused in large part on clinical care, the opportunity arose to return to clinical research at an early phase unit, so I jumped at it! Since then, I’ve held roles in all phases of drug development and worn many hats.

Today, my interests lie in neurodegenerative, neuromuscular, and immune-mediated research, and particularly in rare diseases. On average, a patient with a rare disease visits about seven specialists before they get a correct diagnosis, and that can take up to 5-8 years. So you can imagine the impact on quality of life for a patient who has waited for years, to finally gain a diagnosis for their condition and then a treatment.

ArcheMedX:

You’ve been quite a proponent of technology adoption in clinical research and operations. Certainly COVID-19 has accelerated that adoption and the hope for virtual trials. What unique challenges do you see for technology in your particular field?

Olugemo:

COVID has unearthed that the clinical research field is woefully unprepared for virtual or even hybrid clinical trials. We now realize that this is a critical need. Sponsor companies have had to adapt to social distancing measures. We will have to become more efficient in clinical trials using the technologies we have. 

Rare disease populations have a very high unmet need. There are unique challenges for sponsors who begin trials in these populations, and it’s a perfect example of an area where technology adoption can have a major impact.

I’ve written before about the value of technologies that are pervasive today, such as wearable devices. Watches and wristbands have been used to a large extent as monitoring devices by consumers – but they also expand the options for measuring endpoints in trials studying a condition like Parkinson’s or MS. These and other types of wearable devices can be used in a diagnostic or biomarker capacity, including assessments of walking speed, seizure detection, or perspiration. 

The fact that the diseases are rare means the patient population is small, and you need to be able to find, recruit, and retain these patients – and know how to replicate those studies. Wearable devices with carefully validated endpoints can increase study power, ultimately requiring fewer participants and accelerating study conduct. 

ArcheMedX:

What technology have you been keeping up with?

Olugemo:

Outside of what COVID has accelerated, I’m also keeping an eye on technologies like nerve implants, and robotic exoskeletons to treat spinal cord injury. I truly think that the wave of the future will be marrying technology with biology and genetics, in addition to all the other intelligence and resources we have, in order to cure disease.

Precision medicine is a major emerging area. The study of genetic diseases has really been picking up steam. Previously, we couldn’t have targeted diseases like spinomuscular atrophy. Now we’re able to create therapies to target the genome or RNA with sustained delivery. That’s really been the biggest area of breakthrough that I’ve seen in my therapeutic area of research.

ArcheMedX:

So do you see the age of the virtual trial as attainable? 

Olugemo:

Absolutely. I see a future in which every single trial is hybrid, with the majority in a virtual capacity. The current model is not sustainable. As far as technologies, I’ve already mentioned wearables and sensors; I’m also particularly interested in digital therapeutics in CNS. 

ArcheMedX:

With any sort of change or innovation, there’s bound to be pushback or obstacles to adopting these sorts of technologies, regardless of their value or utility. What challenges do you see?

Olugemo:

People in general are resistant to change, and they look for the path of least resistance. Having a different mindset is critical. Perhaps one thing that COVID-19 will change within society is that mindset – and will force many in the life sciences to rethink their inertia. 

Specifically with sensors and wearables that collect data, there’s always a great risk with privacy. It’s becoming more of an issue, and we’ve seen a number of data breaches in the industry. That can’t continue. As we continue to increase the ability to amass data from sensors and wearable devices, like fingerprints, genetic profiles, photos – we must get a handle on data management and privacy controls.

ArcheMedX: 

With all of this change, it’s critical for the entire lifecycle of therapy development to become more efficient. So how can clinical development and clinical operations improve how they work together?

Olugemo:

There needs to be a lot more collaboration in all of the functional areas and stages in the product’s lifecycle from the beginning. We need to really have the goal of delivering a safe, valuable and effective treatment to patients at the beginning. 

Previously, we separated many clinical trial activities and worked in silos. In designing a clinical program and creating a target product profile, all considerations should be at the forefront – have we identified symptoms that are relevant to patients?, does the treatment improve on existing standard of care or address an unmet need? Is the study designed in an efficient way that fosters patient participation and retention? We have to move beyond the narrow-minded thinking that simply drives one to get a statistically significant result solely for regulatory approval. 

ArcheMedX:

So what other advice do you have for clinical operations professionals for the next 3-6 months as we either emerge from COVID or experience a second wave?

Olugemo:

Certainly, the unique circumstances brought on by COVID-19 should place a priority on clear and precise documentation. There could be very few site visits and there could be many patients who have experienced COVID-19 or will be impacted by it, so I’d expect many protocol deviations, especially if you don’t amend your protocol. Trial teams must make sure adverse events and protocol deviations related to COVID-19 are clearly documented, so that data is interpretable.

More than anything, though, I’d urge the industry to be ready and willing to accept the new normal. We have to adopt the technologies that we already have but are underusing if we want to succeed with virtual trials. E-consent, remote monitoring, telemedicine, wearables, all of these things are available now and will be key to ensure you can perform your trial outside of a traditional study site.  

ArcheMedX:

Kemi emphasizes the need for broader and more efficient technology adoption in clinical research. More widespread use of the technologies we already have available is critical if we hope to propel life sciences forward to be able to support hybrid or full virtual trials. Whether the technology is wearable devices, sensors, or digital content delivery like we provide with Ready, sponsors and CROs may well survive or succumb based on their appetite for technology use.