The FDA’s draft guidance on broadening eligibility criteria and increasing diversity in clinical trials needs more definition and depth, according to drugmakers, clinical trial organizations and patients responding to the agency’s call for comments on the document.

A common theme in the 90 separate comments on the guidance was the lack of clarity on how to determine a representative participant sample. Several commenters asked the FDA to develop a statistical model or metric to help sponsors design trials and set eligibility criteria that result in an adequate patient sample.

Broadening eligibility could open trials to more medically complex patients, Roche/Genentech wrote, such as those with other conditions, unique racial characteristics and varying age and body profile.

In addition to sponsors, CROs and academic research centers, more than half of the comments were from individuals, many representing the EndBrainCancer Initiative, a patient advocacy organization. The draft guidance, Enhancing the Diversity of Clinical Trial Populations, was issued in June (CenterWatch, June 10, 2019).

The FDA needs to “more clearly elucidate the scientific reasons for its focus on diversity,” the Brigham and Women’s Hospital’s Multi-Regional Clinical Trials Center (MRCT) said.

Novartis’s comment sounded a similar note, saying that “enrolling these diverse subjects in clinical trials before much is known about the drug could jeopardize patient safety.”

Several commenters raised the issue of adding pediatric components to a trial. “Under what criteria would it be appropriate to include children in a confirmatory phase 3 trial?” MRCT asked. “Should children be analyzed as a separate subgroup or as part of the overall population?”

Clinical Research Pathways (CRP) lamented the fact that “there is no direct mention of race and ethnicity” in the draft guidance, leaving it to the industry to guess what the FDA means by underrepresented and minority groups. The guidance should provide direction specific to involving African Americans, Latinos and Asians, CRP said.

PhRMA joined MRCT in calling for the inclusion of real-world evidence (RWE) and real-world data (RWD) to better understand effects on diverse populations beyond study groups. “PhRMA believes that RWE/RWD could potentially complement and support the findings of a clinical trial in the broader patient population and enhance the diversity of patient population studies,” the group wrote.

MRCT also noted that the guidance mentions only drugs trials, pointing out that the topic of diversity applies to medical devices as well as other types of biological products.

Read the comments here: https://bit.ly/33DwIx1.

Read the draft guidance here: https://bit.ly/2Z0jr2n.