Lisa Henderson

Mary Costello, Head of Site and Investigator Network at Medable, and Pat Larrabee, CEO of Rochester Clinical Research, discuss their extensive careers in the clinical trials industry, as well as talk about their article in our October issue, “

Podcasts

Mary Costello, Head of Site and Investigator Network at Medable, and Pat Larrabee, CEO of Rochester Clinical Research, discuss their extensive careers in the clinical trials industry, as well as talk about their article in our October issue, “Why Siteless Trials Won’t Work.”

Keeping Sites at the Center of Clinical Research

This month’s phrase to watch: “warm and ready” or “ever-warm.” Clearly lacking in business-speak, I found this term repeated at least three times in the past week, so for me, that speaks to a trend. Two instances were in regard to clinical trials sites, and one in regard to vaccine and therapeutics
production capabilities.

Warm and ready is a comforting term. Of course, because its opposite is cold and unprepared, or frigid and inaccessible. In the world of clinical trials, it is coming to the fore in response to future pandemic readiness. That is, in order for sites to be able to pivot quickly to clinical trials in the face of a crisis, those sites would need to be up-to-speed with capabilities and scale. What one person described as a “ready-made pandemic clinical trial network.”

That description came during the Reagan Udall Foundation’s Public 

 titled COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics. There were three panels, all of them interrelated, however, the first recommendation from this panel was stated: Identify and leverage existing clinical trial network infrastructure (incl. NIH-funded networks, nonprofit & industry/CRO sites networks) and public-private partnerships (e.g., ACTIV) to maintain a ‘warm base’ for public health emergencies (PHEs) and that can be deployed against high priority unmet needs.” Out of this need to increase the number of sites, additional recommendations such as engaging more community-based institutions and networks, increasing diverse populations in clinical trials, and best practices for increasing participations from those communities.

These are not new ideas. Warm and ready sites, maybe, but embedding trials in the healthcare setting? Increasing diverse trial participation at the site level? No. The problem is how to keep sites monetized at a warm and ready level. The panel recommended a blend of industry and government monies, but that’s for another day. This day is to review our feature article on page 10 and discover that there are a number of new industry business models that are working to get more diverse populations, closer to the point of care into clinical trials.

 doesn’t use the term warm and ready, but it succinctly outlines what the Reagan Udall workshop brought to light: “the need to to support the development and long-term sustainability of an infrastructure that unites clinical research with clinical care.”

 is Editor-in-Chief of Applied Clinical Trials. She can be reached at 

Articles

Industry-wide unity paves path for preparedness.

“Warm and Ready” Clinical Trial Sites

Jaydev Thakkar, COO of Biofourmis, talks about decentralized trials, clinical research as a care option, digital therapeutics, and what Biofourmis is working on.

Digital Apps and Tech for Patient Engagement

Raj Indupuri, CEO of eClinical Solutions, talks about the build vs. buy pendulum faced by CROs, the pros and cons of each model, and more.  

Clinical Trials Solutions: Build vs Buy

 our contributor casually introduced this possibility. Could advances in technology across the clinical trials board correlate to a decreased use of CROs and a move to bring clinical trials operations back in-house to the sponsor?

Prior to the pandemic, I traveled to numerous conferences where sponsor speakers shared experiences of bringing their trials back in-house. Usually they were on a smaller scale–a pilot of sorts–but still interesting. In an interview for the main feature, Peter Benton, President and Co-CEO of Worldwide Clinical Trials, noted: “In some cases, larger sponsors are taking their CRO services in house, bringing on their own tech stack, labs, and employees. It will be interesting to see how this strategy will serve them over the long term.”

For as long as CROs have been around, technology has been a competitive differentiator. Consider Parexel’s early (2005) purchase of Perceptive Informatics. The CRO wanted to capitalize on the technology firm’s portfolio including cutting-edge clinical solutions at the time—web-based portal solutions, tracking tools, IVRS, CTMS, electronic diary and investigator database solutions, as well as medical diagnostics services.

three CROs discuss their use of Veeva Systems’

 solutions to increase their capabilities for agile study design and artificial intelligence to execute trials for their clients.

Similarly, Oracle reports in the main feature more CROs looking to the company to design agile systems to address their clients’ needs.

Sponsors, too, could take advantage of the plethora of agile solutions, but is that a reality? Benton believes that clinical trials are a quintessentially human endeavor, and technology a tool. “The human touch will always be needed in clinical trials, and CROs will still have an important role to play in providing strategic guidance, analysis, confirmation—all things that technology can support but cannot entirely replace. CROs that embrace the new technology and innovation will lead the industry rather than being left to fear the outcomes of change.”

With almost 80% of clinical trials in the hands of a CRO, it would be a revolution of sorts if all went back in-house. Benton points to the sponsors’ ultimate responsibility for regulatory risk of bringing new pharmaceutical offerings to market. “Bringing the CRO activities in-house, however, means that the organization isn’t just responsible for the regulatory outcomes, they would newly assume the operational risks as well.” A point well taken.

A move back to in-house management of clinops could be on the horizon for sponsors.

Could Technology Supplant CROs?

Scott Gray, founder and CEO Clincierge, discusses the biggest changes in trial operations, patient centricity, and shares a few stories about obstacles overcome during the coronavirus pandemic.  

A Touch of Hospitality for Clinical Trials

Brad Power, Founder of CancerHacker Lab, speaks about his innovative crowdsourcing approach to help cancer patients, his own battle with lymphoma, and the unique challenges brought to the table by clinical trials in oncology.  

CancerHacker Lab

 this issue is about the future challenges for clinical trials. The article focuses on adaptive trial design, trial designs using synthetic control arms, increased use of biomarkers, increased use of technologies and data sharing, and increased value creation in Phase I and Phase II. All of these will help future proof the industry.

And our contributor did highlight some of the barriers to these progressive goals, whereby risk aversion among sponsors, and education for the general public and healthcare practitioners about clinical trials, would go a long way.

But there is one aspect of not only clinical trials, but all of pharma, healthcare and every other industry, that is a consistent threat to the future. And that is cyberattacks. We edited out the cyberattack discussion in the originally submitted article because it’s such a larger discussion, we didn’t want to confine it to a mere mention for the future of the industry. However, we aren’t taking a deep dive on the topic until early next year, so this is just a toe dip.

, Deputy Director & Research Professor Tufts Center for the Study of Drug Development, and founder of CISCRP, noted that cyber piracy “is a huge concern, especially with how valuable data is. More and more steps will be taken to protect against cyberattacks.” Brigid Flanagan, founder of Oriel Research Services, Ltd., a clinical operations consultancy based in Ireland, noted a recent large breach in the Irish Health System two months ago. “Radiology was the worst hit. Physicians are manually writing down orders, and walking them to the lab, it’s been a nightmare.” And it all happened with one employee clicking on a bad link.

Flanagan suggests that sponsors validate the systems of those they are partnering with, and ensure the security of all cloud systems. As for wearables that collect personal information: “If patients are using their own phones, that can tell [the cyberattackers] where a person is located.” She advises her clients in the EU not to let participants use their own phone for this reason.

 from the Center for Strategic and International studies outlines significant cyberattacks in the past 15 years, mostly on a governmental level. However, clinical trials specifically, and healthcare in general, is not immune, as noted in this 

For most companies, balancing IT budgets to both advance digital transformation as well as cybersecurity protections can be difficult. For that reason, it’s been noted that IT security could be moved its own department.

One misclick by an employee can lead to a number of critical issues including clinical data breaches.

Cyberattacks: It’s Not “If,” But When

Dr. Hanne Bak, Senior Vice President of Preclinical Manufacturing and Process Development at Regeneron speaks about her role at the company as well as their work with monoclonal antibodies, the regulatory side of manufacturing, and more.

What Can ClinOps Learn from Pre-Clinical?

Mike Rea, CEO and Founder of IDEA Pharma, speaks about how his newly launched sister company—Protodigm—takes lessons learned from IDEA, combined with ideas borrowed from engineering and tech development, to form a new concept in pharma and biotech to innovate drug development with minimized risk and without bias.