June 18, 2019
Authored and Edited by M. Andrew Holtman, Ph.D.; Shannon Patrick*
On June 7, 2019, FDA issued a draft guidance on “Enhancing the Diversity of Clinical Trial Populations - Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry.” The draft guidance recommends approaches that sponsors of clinical trials supporting drug applications can use to broaden eligibility criteria and increase enrollment of underrepresented (demographic and non-demographic) populations. The guidance applies to all types of drug products, such as biological drugs and even those directed to life-threatening conditions or diseases.
FDA issued the draft guidance to satisfy § 610(a)(3) of the FDA Reauthorization Act of 2017. The draft guidance recognizes that many participants are excluded for clinically justified reasons. Yet, some population groups are excluded with no justification at all. FDA worries that the failure to include these groups can hinder the clinical study by removing the accuracy for the group and decreasing the overall understanding of the drug.
FDA specifically recommends two approaches to increasing enrollment generally. First, it recommends Inclusive Trial Practices such as examining whether exclusion criteria are necessary to a study objective. Second, it suggests a variety of Trial Design and Methodological Approaches including considering adaptive clinical trials.
FDA also provides examples for the study design to “make trial participation less burdensome for participants,” “adopt enrollment retention practices that enhance inclusiveness,” and “expand access,” all of which may increase enrollment. Ultimately the draft guidance concludes with explanatory recommendations to guide clinical trials in broadening the eligibility criteria, thus improving enrollment, for trials focused on rare diseases. FDA suggests engaging with advocacy groups early in the process, re-enrolling eligible participants, and offering an open-label extension study “to encourage participation by ensuring that all study participants, including those who received the placebo, will ultimately have access to the investigational treatment.”
The draft guidance allows FDA to make suggestions in an effort to diversify clinical trials. FDA believes that a diverse population would more accurately reflect the ultimate group of patients who will use the drug and improve clinical trials. While FDA provides its recommendations, it also encourages others to develop approaches aimed at diversifying enrollment.
Readers are encouraged to read the draft guidance, also available on FDA’s website.
*Shannon Patrick is a Summer Associate at Finnegan
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