Keep Drug Companies Outside Clinical Trial Networks: Woodcock

FDA acting commissioner Janet Woodcock says she believes the nation’s clinical trial network might work best if drug companies remained more outside a revised network framework. In an interview printed online in Outsourcing Pharma, Woodcock says she has “always thought we should have independent people running the trial networks who are not associated with pharmaceutical. I feel like the drug companies should support the infrastructure development, but I don’t think they should run it.”

Woodcock also said she would like to see efforts made to change how patients enter and participate in clinical trials so they don’t lose their connection to their doctor who is treating them. “We need to change trials so we’re not taking the patients away from the doctor so that they can be cared for by their same doctor and in their same community, and so that enough support is offered,” she said. “Maybe there’s a PI (principal investigator) they have to go see once, but then their local doctor can handle most of the care. One of the barriers is that physicians don’t want to refer people to clinical trials, because then they might never see that patient again.”

She also discussed the need for efforts to diversify clinical trial participants. “There’s a collective agreement (among most U.S. agency representatives and leaders) that more needs to be done,” she said, “with a focus on health equity and diversity. You need to reach into these underserved areas and offer them opportunities to participate. If no ever mentioned to you that you could enroll in a clinical trial, that’s a big problem. So things have to change.”