This week, the FDA issued guidance to the pharmaceutical and medical device industries on how to develop a "Race and Ethnicity Diversity Plan" to ensure they are enrolling representative numbers of participants from underrepresented racial and ethnic populations in clinical trials. The guidance explains that "[a]dequate representation of these populations in clinical trials and studies supporting regulatory submissions helps ensure that the data generated in the development program reflect the racial and ethnic diversity of the population expected to use the medical product if approved, and may potentially identify effects on safety or efficacy outcomes that may be associated with, or occur more frequently within these populations."
In the guidance FDA recommends that a Plan be submitted as part of an investigational new drug (IND) application, for a drug, including biological products regulated as drugs, or with the investigational device exemption (IDE) application, for a device. The agency further recommends that the Plan be discussed with the FDA as soon as practicable during medical product development.
FDA expects these Plans to include "the operational measures that will be implemented to ensure diverse clinical trial participation." Examples of such measures include:
- offering financial reimbursement for expenses incurred by participation in a clinical trial or study (e.g., travel or lodging);
- providing language access to participants with limited English language proficiency; and
- partnering with community-based organizations to provide support to study or trial participants.
Although the submission of a Race and Ethnic Diversity Plan is just recommended, the guidance states that FDA "will evaluate the Race and Ethnicity Diversity Plan as an important part of the sponsor’s development program." In fact, the FDA states that this issue is of sufficient importance that "[i]n the event that recruitment goals are not met despite best efforts, sponsors should discuss with FDA a plan to collect this data in the post-marketing setting."
It remains to be seen how the FDA will review these Plans and measure their effectiveness in including more diverse participation in clinical research; however, the guidance bolsters the FDA's commitment to that goal.