Bringing Oncology Biosimilars to Patients - Episode 15

The FDA and Diversity in Clinical Trials

Amanda Forys, MSPH: Do you think the FDA has a position on this? [Should they be] putting more out there on exact guidance for clinical trials, or what they want to see in terms of a mix of patients?

Christy M. Gamble, JD, DrPH, MPH: You know, the FDA, they’ve put out a really standard statement on diversity in clinical trials, but they really haven’t taken a step forward to provide those incentives and to push for that diversity.

I know that groups like mine, we’ve written to the FDA, we’ve spoken to certain individuals at the FDA to say how important it is to really take the lead on this issue, as the FDA, because we’re seeing a lot of drugs and vaccines that are not working in our population. It’s not right and it’s not fair because everyone should be included in the healthcare system.

When you have a group that’s been left out of the healthcare system for centuries now, and they don’t have, currently, access to innovative therapies, it’s disturbing and it’s disheartening.

We really would like for the FDA to be a part of pushing us into this century, so-to-speak, or even this decade would be much better when it comes to access to innovative therapies for all patients.