Source: Bizjournals
By Lilly Skok Bunch – Executive Director of Greater Gift in Winston-Salem
Jul 7, 2022
The clinical research system’s mistakes stem from historical events that adversely impacted racial and ethnic minorities, such as the Tuskegee experiments.
Greater Gift is a nonprofit organization whose mission is to increase awareness of clinical research, especially among underrepresented communities.
The nonprofit has submitted a comment letter in support of U.S. Food and Drug Administration Guidance, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials Guidance for Industry.”
According to the FDA, the agency “is focusing this guidance on diversity plans to improve enrollment of participants from underrepresented racial and ethnic populations because the lack of representation of these populations in clinical research reflects, in part, a broader issue regarding differential access to health care, including access to centers that conduct clinical research programs for new therapies and awareness of clinical trials conducted there.”
Greater Gift is focused on two key barriers:
- The requirement of taxpayer identification number (SSN or ITIN) to participate in clinical research studies.
- All U.S. residents can obtain ITINs, but many are unwilling to do so since they are present in the country illegally. Also, many may be missing required documentation to obtain an ITIN such as a passport, which excludes potential participation in clinical research entirely.
The regulations that govern principal investigator (PI) in-person oversight greatly limits the locations where clinical trials can be conducted. In addition to the FDA’s draft guidance, Greater Gift is calling for specific actions:
FDA and (Independent Review Boards) IRBs should jointly pursue federal legislation that will allow reimbursement costs to clinical trial participants to be optional and non-taxable, therefore encouraging all US residents to participate without requiring SSN or ITIN.
A recent partnership with a major pharmaceutical company committed to minority representation in an RSV study resulted in 10 percent of volunteers’ screening failure due to a lack of acceptable Social Security documentation.
Federal legislation should be adopted that relaxes the requirements that limits mobile clinical trials traveling to the neighborhoods where minority communities have access to clinical trials.
Because clinical trial sites are often not located in close proximity to minority communities, it makes transportation to/from, a significant barrier to participation. Reimbursement for travel expenses is not enough when participants are asked to travel well beyond their community, without regard for language barriers.
The time has come for organizers of clinical trials to recognize that in order for medications and devices to be maximally effective for all populations, a diverse mix of clinical trial participants is critical. We’re grateful that the FDA is taking action.
“Minority populations were three times more likely to experience complications from Covid-19 but were not equitably represented in clinical trials for the vaccine,” says Greater Gift board member Harsha Rajasimha, CEO and founder of Jeeva Clinical Trials Inc.
“This challenge presents itself across varying disease states. We must build trust in minority communities to ensure that we are all equitably represented in research,” she adds.
