FDA’s top regulator thinks present clinical research system is broken

Collaborative Clinical Trials.

Janet Woodcock, the director for the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA), does not mince words when it comes to how well clinical trials are working. Still, she is optimistic that the system is changing for the better. In saying that industry should adopt more collaborative studies, the FDA’s top drug regulator was highly critical of the current clinical trial regime. “I believe the clinical trial system is broken,” Woodcock said at an industry panel on November 14. “I do not believe it serves the interests of patients.”

Last year she argued for master protocols in a New England Journal of Medicinereview article. They would provide frameworks to evaluate multiple treatments and diseases in the same trial.

According to an article by Andrew Dunn in Biopharma Dive, Woodcock advocated for three main study types that use master protocols: basket, umbrella and platform trials. As Dunn explained, “Generally, a basket trial tests one therapy against many diseases while an umbrella trial evaluates many therapies on one disease. A platform study focuses multiple drugs on a single disease like an umbrella trial but uses a decision algorithm to let therapies enter and exit the platform. The algorithmic design has led to some skepticism and resistance…Such designs face a tough road to widespread adoption, especially due to market dynamics at play.”

According to Jim Reilly, a vice president at Veeva Systems, a life sciences technology company, industry needs to be persuaded to collaborate when its players have been historically competitive. Still, he has seen “a positive trend of sponsors being willing to work together, particularly in data transparency and standardization.”

Woodcock cited another critical challenge, the fact that platform trials are the most useful in highly competitive research areas, where comparative data and combination results are especially valuable. She added, “So those things have to be navigated, but I believe we’ll get over a tipping point. People will realize the strength of [these trials], then there will be opportunities to go into the community and enlist the community practitioners, which then will result in a tremendous increase in ability to enroll patients and answer more questions.”

Woodcock believes that platform trials with master protocols can more efficiently answer clinical questions. While this design makes competitors to work together, she has witnessed a “groundswell” of recent support. Woodcock thinks clinical trial research is already in the process of changing, because industry and advocacy voices have approached her in recent weeks about starting such studies.



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