With the DEPICT Act having been signed into U.S. law as part of the 2023 omnibus spending bill, clinical research under American jurisdiction must now comply with the FDA diversity plan to achieve racial and ethnic inclusiveness in trials.
Below, we will explore what aspects of clinical research are impacted by the law, what responsibilities researchers have regarding compliance, and what questions still remain.
When to Submit a Plan and What to Include
When the FDA issued its guidance in April 2022, its stated goal was to ensure that organizations sponsoring research of medical products or devices were enrolling a representative number of participants from historically underrepresented racial and ethnic populations in the United States. These include:
- Black or African American participants.
- Hispanic or Latinx participants.
- Indigenous and Native American participants.
- Asian participants.
- Native Hawaiian and other Pacific Islander participants.
- Any other persons of color.
The FDA’s guidance then recommended that sponsors submit a race and ethnicity diversity plan as a measure of accountability. Such a plan should be submitted under the following circumstances:
- When an Investigational New Drug (IND) or Investigational Device Exemption (IDE) submission is required.
- When clinical studies are intended to support a section 351(a) marketing submission for a Biologics License Application (BLA) or a section 505(b)(1) or (b)(2) application for an NDA.
- When clinical studies are intended to support a submission for a 510(k) premarket notification, a premarket approval (PMA) application, a De Novo classification request, or a humanitarian device exemption (HDE).
Section V of the FDA’s guidance outlines what should be included in a race and ethnicity diversity plan:
- An overview of the disease or condition, including representation of the disease/condition among underrepresented populations and evidence as to whether treatment varies across racial or ethnic divides.
- The scope of the medical product’s development program, the design of the trial, population and eligibility criteria, and how selection could impact participant diversity.
- Goals for enrolling participants from underrepresented racial and ethnic populations.
- The specific plan for enrolling those participants, including how community engagement will happen, what the researchers can do to reduce the burden of participation, and how diversity goals will get measured.
- A status update for how well sponsors are meeting their enrollment goals. Should the research team fail to achieve enrollment numbers, the plan should include a discussion on how they can collect post-marketing data.
The Grey Areas That Remain
Bloomberg Law medical research reporter Jeannie Baumann has done an excellent job of covering the legal developments of the FDA’s guidance.
In February, Baumann reported on the fact that the DEPICT Act makes no mention of institutional review boards (IRBs), which are the ethics panels that review any research on human subjects.
This means that, for now, it’s unclear what any IRB’s role will be in assessing a sponsor’s race and ethnicity diversity plan.
“The FDA said in a statement that it’s reviewing and evaluating how to implement the provisions of the new law while engaging with stakeholders on enrolling diverse clinical populations,” Baumann reported.
“Several research attorneys said they don’t expect IRBs to review and approve the diversity plans themselves. The law imposes new requirements for trial sponsors, whereas IRBs tend to work with documents submitted by investigators.”
Further, Bass, Berry & Sims PLC attorneys Clint D. Hermes, Angelique M. Salib, and Jacob B. Stansell note that other questions remain unanswered. Those include:
- Subsidies. Reimbursement and subsidies are useful in lessening the burden of trial participation, Hermes et al. write. However, the FDA’s guidance fails to describe whether subsidizing the costs of the medical interventions that are part of the study represent undue influence.
- Research initiated by investigators. The FDA’s framework assumes a plan will get submitted “after a sponsor seeks feedback on a pivotal trial” for drugs, Hermes et al. write. But when an investigator sponsors the research themselves, this step won’t happen. “Hence, it remains to be seen whether and when FDA will expect Diversity Plans to be prepared for such research,” they write.
- Data that originates outside of the U.S. “It is unclear whether or how the FDA will expect Diversity Plans to account for population or condition prevalence outside the U.S., particularly when most or all of the data supporting a marketing application derives from abroad,” the attorneys write.
The Path to Clinical Trial Equity
The bigger picture in the FDA’s guidance and in lawmakers’ intentions is to further the clinical research universe along the path toward equity in clinical trials.
More accurate patient representation in clinical research is an important step along that path. Other such steps, notes Xtelligent Media Assistant Editor Veronica Salib, include embracing decentralized clinical trials as a way to reduce participation burdens, identifying and rooting out “provider bias and mistrust,” and ensuring the research teams themselves represent the diversity of the populations they’re researching.
Lolita Castrique-Meier and Nikhil Bumb at FSG offer a few questions that are helpful in framing these big-picture goals:
- “How do we determine research priorities?”
- “How can medical affairs teams counter bias and improve clinical care quality for marginalized populations?”
- “Who is accessing our products?”
- “How is health equity incorporated into brand planning and commercialization strategies?”
- “How can partnerships with other stakeholders reduce barriers to care?”
These are some of the questions the FDA wants to help researchers answer, and they are questions that require ongoing collaboration between medical affairs teams and clinical research teams. The perspectives from both departments will help pharmaceutical companies and life sciences organizations see the bigger picture and identify ways to get closer to true equity in clinical trials.
These are precisely the types of questions Anju’s clinical intelligence solution, TA Scan, can help answer. TA Scan lets you visualize global ethnicity data, socio-economic data, and site / PI experience on a single map. You can also filter by age, gender, racial distribution, or average income.
To learn more about how TA Scan can help your research team comply with the FDA’s Race and Ethnicity Diversity Plan, request a demo today.
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