Trial Diversity from a Disclosure Perspective

“Over the last couple of years, diversity has been such a hot topic,” says Fenwick Eckhardt, Senior Manager, Citeline Consulting and Analytics. And, with the Food and Drug Administration (FDA) diversity plan guidance, the industry focus on clinical trial diversity has intensified.

Eckhardt outlined five criteria that the FDA expects sponsors to report on, per the guidance:

1. Overview of the disease or condition in underrepresented groups
2. The scope of medical product development and plans on specifically addressing inclusion
3. Goals for enrollment of underrepresented racial and ethnic participants
4. Specific plan of action to enroll and retain diverse participants
5. The status of meeting enrollment goals

Looking at trial diversity from the perspective of clinical trial disclosure, Sylvia Baedorf Kassis, Program Director, Multi-Regional Clinical Trials Center (MRCT) of Brigham and Women's Hospital and Harvard, co-facilitated a session with Eckhardt at Citeline’s TrialScope EXTRA event. Eckhardt asked Kassis to share insights on the vagueness around this guidance and how the industry is reacting.

Kassis noted that the FDA criteria on race and ethnicity are not harmonized with those of the Office of Management and Budget. “Even though there’s this need to report on race and ethnicity,” she said, “it’s not actually reflecting what our government is asking us to have as categories. So that’s a challenge.” She said these criteria also do not necessarily reflect reporting requirements globally.

“Standardization is a huge issue,” Eckhardt said, acknowledging that there are so many more categories beyond race and ethnicity. She said the FDA guidance specifically points out lactation status and the LGBTQIA+ population. The guidance does mention disabilities, but Kassis said this is an area that requires additional focus.

“It’s multifaceted,” Eckhardt said. However, she said the guidance does not include rare diseases, leaving questions as to what is required in this area.

“Race and ethnicity is, to a great extent, a social construct,” Kassis said. “They are not necessarily biological constructs, not necessarily genetic constructs.” Kassis suggested pushing the envelope, that one’s ancestry, for instance, could provide more meaningful insights.

Kassis also brought up the challenge of age categories. If a sponsor is conducting an Alzheimer’s study and the standard age categories are 0–18, 18–64, and 65 and up, there is no nuance to the last category. “At the end of the day … that 65-plus is not going to be the most meaningful.”

Referring to an FDA public workshop, Eckhardt said one analysis revealed that although 87% of diversity plans submitted during the initial one-year period contained all five recommended components, only 6% of plans on which the agency provided feedback were deemed acceptable.

“I think, ultimately, FDA is only one piece of the puzzle,” Eckhard said. "It’s up to sponsors to set these precedents early on. We won’t get a mandate until 2025, so now is the time to start planning and start trialing different efforts to really be inclusive, to increase representation of underrepresented groups in clinical trials and to report that data.”

In the past, she said, the focus was on census and epidemiology data for collecting demographic information. With this new realm, Eckhardt said the focus is shifting toward real-world data (RWD) such as US medical claims and electronic health records (EHR). Enriching RWD with social determinants of health (SDoH) can help identify needs of underrepresented populations. Eckhardt listed access/transportation, education, income, and urbanicity as a few aspects that should be factored into the equation. Kassis added internet access to the list. The challenge, Eckhardt said, is to avoid the silos inherent with these disparate sources of data.

One way to overcome challenges in recruiting patients from underrepresented populations, Kassis said, is to communicate using plain language. This will go a long way to instill a sense of trust and trustworthiness, she said.

The MRCT Center has many resources available to help sponsors tackle clinical trial diversity. Kassis said the center’s glossary has been adopted as the standard by the Clinical Data Interchange Standards Consortium (CDISC).

Eckhardt (she/her) will be a panelist in a Citeline webinar July 10 held in conjunction with the Association of Clinical Research Professionals (ACRP). The member-exclusive webinar, Deepening Diversity: LGBTQIA+ Diversity in Clinical Trials, will also feature Garo Kiledjian (he/him), Founder & Chief Executive Officer of SGM Alliance; Shir Netanel (she/her), Associate Director of Patient Advocacy and Clinical Trial Advocacy, Global Medical Affairs Oncology, Johnson & Johnson and Liam Paschall (he/him), an advocate for the transgender community.