Clinical Researcher—June 2020 (Volume 34, Issue 6)
Paul Evans, PhD
I recently had the opportunity to appear on an episode of ACRPtv’s “Spotlight On…” series to discuss some of the challenges I see looming ahead of us as an industry as we move toward virtual or hybrid trials. I’m no Luddite, and I’m excited about many of the upsides well-designed virtual trials can bring us, beginning with the delivery of the benefits of clinical trials to wider swaths of the population.
It’s no secret that many minorities and people living in rural areas of the country are vastly underrepresented in clinical trials today. Virtual trials have the potential to change that. Obviously, we should all support anything that delivers the benefits of clinical trials and clinical research as a care option to more patients in a safe and effective manner.
However, I’m concerned we’re letting our enthusiasm get ahead of reality. Transforming an onsite trial into a virtual trial isn’t something that can be done by flipping a switch. Just ask teachers who’ve been told to make their in-class lessons virtual, as if the challenge could be solved with the creation of a few Excel forms and a Zoom meeting or two.
Before we get too far ahead of ourselves, we must address overly complex protocols. We’ve seen a classic case of “mission creep” over the past several years as trials have become more complex and the demands on clinical trial practitioners more stringent. We need to ask ourselves if we really need certain datapoints as we set up a trial, or are we asking a question merely for the sake of asking it?
I worry that, minus taking a close look at how we operate, we will revert to form in some ways as the COVID-19 crisis begins to recede from memory. Historically, our industry has not been quick to welcome new technologies and new ways of doing things. For example, the rollout of electronic data capture technology arguably took us the better part of two decades to truly adopt it and get to the point where it’s now routine.
The kinds of protocols we need to adopt this new modality simply aren’t there yet, and it’s going to take some time to reach the point where they are available. Frankly, it’s probably not this generation of protocols where we will meet the challenge. It’s what we do with the next generation of protocols where we can seize the opportunity to truly modernize clinical trials from a technology and best practices standpoint.
COVID-19 has been a frightening and sometimes horrific experience, especially for clinical trial workers on the front lines who have watched people suffer and die. However, it has also presented us with a chance to improve. Let’s work together to adapt the best of hybrid and virtual trials while holding onto the best of in-person monitoring.
We owe it to our industry, to our patients, and to ourselves to wrest anything positive we possibly can out of this experience.
Paul Evans, PhD, is President and CEO of Velocity Clinical Research, and Chair of the Association Board of Trustees for ACRP in 2020.