“Warm and Ready” Clinical Trial Sites

Applied Clinical Trials, Applied Clinical Trials-10-01-2021, Volume 30, Issue 10

Industry-wide unity paves path for preparedness.

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 Workshop 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.

This NEJM opinion piece 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.”

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials. She can be reached at lhenderson@mjhlifesciences.com.