Bass, Berry & Sims attorney Clint Hermes offered insight on what clinical researcher attorneys expect imminent draft guidance from the Food and Drug Administration (FDA) will say about diversifying clinical trial participation. As the reporter points out, “because the efficacy and safety of treatments can vary across patient groups, many drug industry leaders and regulators are eager to widen the net and include more historically underrepresented populations” in clinical trials.
One of the biggest questions the industry hopes will be answered centers around the ramifications when clinical trials don’t meet enrollment goals. Clint said he “would be curious to see if the FDA clarifies what, if anything, might happen in those circumstances, including what it could mean for FDA approval of a drug or device or if there are any implications in the post-marketing context.” Clint added, “they could specify that that would affect the FDA’s review of a marketing application.”
Another topic the industry is awaiting guidance about focuses on clinical trials conducted outside of the United States. Clint noted that “using data from people overseas can add another degree of complexity” to FDA-required diversity action plans, “depending on how generalizable that data is to U.S. populations.” Given how common it is for trials to be conducted overseas, Clint hopes this question will be addressed in the forthcoming FDA guidance.
The full article, “What Clinical Trial Attys Want from FDA Diversity Guidance,” was published by Law360 Healthcare Authority on June 4 and is available online (subscription required).