By Luke Gelinas, PhD, IRB Chairperson
The immense negative health, social, and economic impact of COVID-19 demands a wide array of clinical trials evaluating diverse therapies for ameliorating and preventing the disease. To date, government and industry funders have been quick to respond. In a recent webinar, US Food and Drug Administration (FDA) representative Janet Woodcock estimated that the FDA has received over 950 inquiries or proposals for COVID-19 drugs, with 72 of those currently being evaluated and over 200 in the planning stages.
While these numbers are encouraging, Woodcock expressed concern about the ability of the research community to evaluate all of them. “Although we may not run out of patients, unfortunately,” she said, “we may run out of research personnel and time availability to do that in this way of having separate development programs.” Woodcock went on to extol the virtues of “adaptive” and “platform” trials as a way of eliminating less-promising investigational treatments quickly and speeding development of COVID-19 therapies, as exemplified in the current UK-based RECOVERY trial.
Such designs have gained favor recently with regulators and sponsors but remain under-utilized. Moreover, many IRBs may be unfamiliar with reviewing them. The current circumstances give us a chance to reflect on their features and benefits, challenges for IRB review, and strategies for facilitating adoption.