An Overview of Diversity Plan and How to Write Them: Guidance for Industry
Background and Purpose
The FDA recognizes the importance of enrolling participants from underrepresented populations in clinical trials to ensure the safety and effectiveness of medical products for all patients. However, there are persistent challenges and barriers to achieving adequate representation of these populations in clinical trials.
Therefore, the FDA has issued a guidance document to provide recommendations on how sponsors can develop and implement diversity plans to improve the enrolment and retention of participants from underrepresented populations in clinical trials.
A diversity plan is a comprehensive and proactive strategy to address the factors that may affect the enrolment and retention of participants from underrepresented populations in clinical trials. These were initially for racial and ethnic populations but now include other demographics such as sex, gender identity, age, socioeconomic status, disability, pregnancy status, lactation status, and co-morbidity groups.
When should you create a Diversity Plan?
A Diversity Plan is recommended for medical products for which an IND submission is required and/or for which clinical studies are intended to support a marketing submission such as BLA, NDA, IDE, PMA, and HDE.
Is there a Diversity Plan template?
There is no specific template for a Diversity Plan. However, the FDA guidance has a detailed outline of the recommended components.
What components should be included in a Diversity Plan?
Diversity Assessment
Identify target population, disease or condition, and racial and ethnic impact.
Analyse current and desired diversity in clinical trials.
Identify gaps and barriers to enrolment and retention of underrepresented populations.
Diversity Outreach and Recruitment
Describe methods and strategies to reach out to and recruit underrepresented populations.
Engage with community partners and use culturally and linguistically appropriate materials and messages.
Provide incentives and support for participation.
Diversity Monitoring and Evaluation
Outline metrics and methods to track and assess diversity plan progress and effectiveness.
Monitor enrolment and retention rates of underrepresented populations.
Ensure quality and completeness of data.
Collect and analyse feedback and satisfaction of participants and stakeholders.
What are the timelines and process for submitting a diversity plan?
The timelines and process for submitting a Diversity Plan are as follows:
Sponsors may discuss their strategy to enroll a diverse study population at any time throughout the medical product’s development.
For drugs, sponsors should submit the Diversity Plan to the relevant IND application as soon as possible during drug development. It is recommended to submit the plan before seeking feedback on the applicable pivotal trial(s), which is often done during the EOP2 meeting.
When submitting an IDE application for devices, sponsors should include their Diversity Plan as part of the investigational plan. For clinical studies not conducted under an IDE, sponsors should follow the Q-submission process to discuss the proposed enrolment strategy or request a meeting with the FDA.
To ensure the Diversity Plan is recognized, sponsors should mark their IND, IDE, or Q submissions with "RACE AND ETHNICITY DIVERSITY PLAN" in large, bolded type in the cover letter. This is important for effective communication with the FDA.
When preparing the marketing application for the medical product, sponsors should include the Diversity Plan. Additionally, it is beneficial to provide a description of both the successes and challenges experienced during the implementation of the plan. This information will help evaluate the effectiveness and impact of the Diversity Plan.
How Morula Health can help:
Morula Health is a medical writing partner that specializes in clinical trial documentation and regulatory submissions. Morula Health can support biotech, pharma, and device companies with developing and implementing diversity plans for their clinical trials by providing the following services:
Conducting diversity assessments based on the latest scientific and epidemiological data, as well as the FDA guidance and best practices.
Our experts create monitoring and evaluation plans, meeting FDA requirements and aligning with your study design and endpoints.
Morula Health can adapt and modify study protocols to ensure compliance with local regulations, cultures, and languages in the countries where your trial takes place.
Writing and editing diversity-related documents, such as informed consent forms, patient brochures, and recruitment materials that are clear, accurate, and compliant with the FDA standards and formats.
We facilitate communication and collaboration with biotech sponsors, FDA reviewers, and all essential stakeholders. Our goal is to ensure the smooth and successful implementation of your diversity plan.
Morula Health has a team of experienced and qualified medical writers who have extensive knowledge and expertise in writing up diversity plans. Morula Health can help biotech, pharma and device companies achieve their diversity goals and demonstrate the safety and effectiveness of their medical products for all patients.