FDA Diversity Action Plan for Clinical Studies: Specific Aspects

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The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance document dedicated to Diversity Action Plans to improve the enrolment of participants from underrepresented populations in clinical studies. Once finalized, the document will provide information about the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by the parties responsible for clinical trials. 

At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legal framework and has been agreed with the authority in advance.

Timelines for Submitting Diversity Action Plans

Study sponsors are encouraged to discuss their Diversity Action Plans with the FDA as early as possible during medical product development. However, there are specific timelines for submitting these plans for certain clinical studies involving drugs and devices.

Sponsors must submit the required Diversity Action Plan to the relevant Investigational New Drug (IND) application as soon as practicable but no later than the date when the sponsor submits the protocol for the phase 3 study or another pivotal study to the FDA. The FDA recommends submitting the Diversity Action Plan during discussions about trial design and study population selection, typically at the End-of-Phase 2 meeting, for efficient review and feedback.

For device clinical studies that require an Investigational Device Exemption (IDE) application, the Diversity Action Plan must be included in the IDE application. For studies not requiring an IDE application, sponsors must develop a Diversity Action Plan to guide clinical study development and submit it as part of the device’s premarket notification (510(k)), Premarket Approval (PMA) application, or De Novo classification request.

The FDA also acknowledges that some device studies may not need a Diversity Action Plan, particularly those not designed to collect definitive evidence of safety and effectiveness. When specific guidance is needed before submitting a Diversity Action Plan in an IDE or marketing submission, sponsors should use the Q-submission process to request feedback or meetings with the FDA.

Procedures for Submitting the Diversity Action Plan and Receiving Feedback

According to the guidance, the submission process for drugs should be as follows:

• The Diversity Action Plan must be submitted to the IND under which the clinical study will be conducted.
• The title page should include administrative information such as the drug name, IND number, proposed indications, study identification information, and the version number and date of the Diversity Action Plan.
• The cover letter should alert the FDA that the submission includes a Diversity Action Plan, specifying if it is new or revised.
• Feedback from the FDA may be provided at their initiative or upon the sponsor’s request. Specific questions can be included in discussions during FDA meetings.
• Modifications to the Diversity Action Plan can be submitted based on FDA feedback or the sponsor’s initiative, including a tracked changes version and a clean version, along with a summary and justification of modifications.
• For INDs required in eCTD format, submissions must be in eCTD module 2.5.
• The status of the Diversity Action Plan and any discussions with the FDA should be included in regulatory histories for milestone meetings and marketing submissions.
• Annual reports must update the progress toward meeting Diversity Action Plan enrollment goals, including reasons for not meeting goals and plans to address these issues.
• Marketing application submissions should include an overview of the Diversity Action Plan, an assessment of whether enrollment goals were met, and any contributing measures. If a waiver has been granted, this should be indicated and cited.

The guidance also describes the relevant process for medical devices, which is slightly different:

• Sponsors may submit a pre-submission to request feedback or a meeting regarding the Diversity Action Plan.
• The Diversity Action Plan must be part of the IDE application for SR device studies.
• For device studies not requiring an IDE, the Diversity Action Plan must be included in the 510(k), PMA, or De Novo submission.
• The cover letter should clearly indicate if the Diversity Action Plan is new or revised.
• Relevant administrative information should be included on the title page.
• Modifications can be submitted based on FDA feedback or the sponsor’s initiative, including tracked changes and a clean version, with a summary and justification.
• For SR studies, modifications should follow the guidance for changes to approved IDEs.
• Marketing submissions should include a summary of discussions and correspondence with the FDA regarding the Diversity Action Plan.
• Periodic reports should update progress toward enrollment goals, reasons for not meeting goals, and mitigation plans.

Public Posting of Diversity Action Plans

In addition to the above, the FDA encourages sponsors to share their Diversity Action Plan strategies publicly. Key information such as enrollment goals disaggregated by race, ethnicity, sex, and age group, along with measures to achieve these goals, should be posted on the sponsor’s website. 

Links to recruitment websites or clinical trial repositories like ClinicalTrials.gov can enhance accessibility. Information should be presented in consumer-friendly language.

Conclusion

In summary, the present draft guidance developed by the FDA covers all the important aspects related to the development and implementation of Diversity Action Plans intended to ensure the scope of study participants enrolled properly represents all the relevant patient groups, ensuring the accuracy and reliability of the study results in general. 

Source

https://www.fda.gov/media/179593/download

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