Planning Ahead for 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: What does the guidance mean for sponsors and other stakeholders involved in trial design?

Kashoki: Staying on the theme of diversity and ensuring diversity, it means that companies must begin to plan their global oncology programs much earlier than they probably were thinking, probably as early as Phase I, definitely before Phase III. In the oncology space, we know that companies are often seeking accelerated approval, so they might be seeking approval on a limited number of trials or Phase II study results, so it's important that their study population, even up to the phase of Phase II is appropriately representative. They've also got to be thinking about ensuring diversity of their Phase III trial populations, because the Phase III trials which are confirmatory and completed post-approval in the accelerated approval circumstance, these Phase III trials must be underway at the time of the accelerated approval decision, so companies must be proactively planning very early. How do we enroll an appropriately representative population for the US right as soon as possible in our program, if we're planning a global program?

I mentioned that the FDA is encouraging expansion of the types of sites for multiregional clinical trials. This, in turn, means that companies must think how we actually run these trials in a community-based site, just to keep that as the example, how will we collect the data? Often, these are not sites that have incorporated clinical protocol, clinical trial protocols, into their practice, so there is some learning first, but there's also the matter of data capture and especially in the community setting, you want the protocol to be as streamlined and as least burdensome as possible to the investigators as well as the patients, so thinking about, how do you incorporate the data capture that's happening as a matter of clinical care into your clinical trial protocol becomes an important consideration. It was interesting to me that very shortly, either before or after the multiregional clinical trial guidance came out, the FDA also issued a guidance called integrating randomized control trials for drug and biological products into routine clinical practice, and that provides recommendations on how to best collect data in a clinical trial such that it is reflective of routine clinical practice. I'm sure there was a lot of internal conversation within the FDA about how to tie all of the recommendations together, but I think for companies, when they are planning their global trials, thinking about their sites, they now have to think even further. How are we going to design the study of data collection so that it's easy to do in those additional sites.