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 is your initial reaction to the FDA’s latest guidance on conducting multiregional clinical trials in oncology?
Kashoki: I thought that the guidance actually is quite timely, and it is reflective of adding to the ongoing conversation that the agency has been having about the need to ensure that the patients in clinical trials are indeed representative of the target patient populations. We know that in 2022 there was the passage of FDORA, the Food and Drug Omnibus Reform Act and that established the requirement that companies or drug developers actively plan for how they are going to increase enrollment of underrepresented populations in clinical trials, and of course, that’s for the purpose of ensuring that there’s ability to assess for generalizability of the results to the target US population. Now, what this new guidance on multiregional oncology trials does, it expands upon that principle, it’s basically saying that when a company has a global clinical development program, it’s got to make sure that it’s making plans actively to ensure that the data collected from these multiregional trials is indeed applicable to the US population. In other words, when you’re designing a multiregional clinical trial, you should, as a company, consider that there’s important differences in the US population, but to the patient characteristics, disease factors, our healthcare system characteristics, etc., and these have to be taken into account during the analysis of the results and therefore the interpretation of the results. The guidance is saying, proactively plan your studies, these multiregional trials, and making sure that you’re taking into full account all of the impact factors, so the timeliness of the guidance vis a vis the larger conversation that’s happening around ensuring diversity of clinical trial populations was notable to me.
I also thought that it was helpful in that it’s a guidance that consolidates the information that FDA has been giving to companies—more on an individual basis—in meetings to discuss the company-specific development program, their specific clinical development program, challenge, or opportunity and as the FDA has been gaining more and more experience with global trials, everyone’s looking at a global development program, it seems like the agency is now in a position to consolidate its learnings and the best practices for companies, particularly for oncology trials, because those can be very rapid. They can be based on a handful of trials of certain designs, so it’s important that the FDA put out this guidance in a consolidated manner to oncology drug developers so they can proactively plan, as I said earlier, and of course, to help the FDA in its regulatory decision making.