Future Impact of FDA’s Multiregional Clinical Trials Guidance

In a recent video interview with Applied Clinical Trials, Mwango Kashoki, SVP, global head of regulatory strategy, Parexel, discussed the FDA's new guidance for multiregional oncology trials, emphasizing the need for diverse patient populations in clinical trials. The guidance requires companies to proactively plan trials to ensure data applicability to the US population, considering factors like patient characteristics and healthcare systems. The expected outcome is better-designed trials with broader access and representation.

A transcript of Kahsoki’s conversation with ACT can be found below.

ACT: Looking forward, what do you think the future impact of this guidance will be?

Kashoki: Well, ultimately, I'm hopeful. I'm always encouraged by new guidance. I think guidance represents the progressive thought, the advancement of new ideas, the solidification of advice and experience and embeds into practice the drug development that we all are engaged in. Ultimately, I think that the guidance is going to result in even better-designed oncology, multiregional trials. I think these will be conducted in a wide range of sites and locations, and yield information that is helpful across the globe. In the US specifically, I think the most visible, maybe even the more immediate impact will be where the trials are run. We'll begin to see, as I mentioned earlier, diversification of investigators, and we're going to see a diversification of study participants. People are going to have to talk even more with one another, so the community-based healthcare providers talking about their needs, their systems, how to integrate with maybe some of the complexities that may be required for clinical trials that will need to be adapted, perhaps. Overall, it opens the door wider, I think, to oncology patients to receive investigational oncology products as a therapeutic option. Hopefully it’s better for all.