Ensuring Greater Access and Diverse Patient Populations

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: How does the guidance address greater access to trials and more diverse patient populations?

Kashoki: I'll point out a couple of examples that stood out to me, but certainly from the very beginning, the guidance says, in order to ensure that you are developing a program that is going to be appropriately representative, you've got to look at the characteristics of the patients that you're targeting, so that includes the demographics of the populations and any unique physiologic characteristics of the target population, beyond race and ethnicity. The analysis of the target population, bakes in in the aspect of diversity of the trial populations.

A couple of things to expand on. The guidance also notes that the companies can enroll foreign participants into trials, so inclusion of sites in foreign countries where the participants would have features, characteristics that would be applicable to populations here, so if you had a site in Africa, there might be parallels that could be made to an African American population as an example, so when there is sound reason from a clinical, medical scientific perspective to make the correlations between a population that is in a foreign site versus a US site, then go ahead, include these foreign sites in your multiregional clinical trial. This expands the access of these investigational oncology products to patients beyond the traditional locations, we'll call it, and expands access to traditionally underrepresented populations.

Another important aspect that I noted in the guidance is the encouragement to diversify the clinical trial sites beyond our typical academic tertiary care center. There's mention of community-based sites, as an example. This is important because we know that that will permeate to the access of clinical trials, to a broader population who may have accessibility issues, who may want to stay with their provider, whether that's an individual person or location. It's also important because expansion to community sites expands the diversity of the investigators themselves, so now you have community-based physicians learning and employing clinical protocols into their daily clinical practice. There's a lot of data that exists already on the benefits of community-based clinical trials, I won't expand upon that there, but it's notable that the agency is saying, as well as in the oncology space, consider community-based trials.