Have you heard about the FDA diversity plan? If working in the clinical trials arena, you SHOULD. Since I have been an early bird involved in diversity plan writing (starting end of 2022), here are some takeaways:
👩⚖️ Regulatory background:
The FDA draft guidance "Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials.” was released in April 2022 (link here).
The FDA wants to discuss the Sponsor's Race & Ethnicity Diversity plan no later than when the Sponsor seeks feedback on planned pivotal studies (usually EOP2 meeting).
🎯 Purpose:
The ultimate goal is clear: Efficacy and safety data should not focus on White patients but also be valid for patients of other ethnicities/races.
In other words: Data generated in the development program should reflect the racial & ethnic diversity of the intended population of use.
How could this be achieved? Avoiding underrepresentation of specific racial populations within the clinical trials.
📃 Key content - What should the diversity plan contain?
✅ The enrollment target per ethnicity/race (justified based on epidemiology data)
✅ Planned subgroup analyses
✅ The operational plan (how and when will you achieve this: up to Phase 3 or after marketing authorization?)
👩⚕️ Key functions to be involved:
Clinical - Regulatory Affairs - ClinOps - ClinPharm - Epidemiology - and your Medical Writer!
✒ Why are Medical Writers (MW) important for this deliverable?
💫 Too much is at stake! As for any regulatory deliverable, only provide high-quality documents to the FDA.
💫 The plan has major strategical implications (up and beyond a drug's marketing authorization): The function-overarching & analytical capacity of a MW might detect weaknesses and even have some strategical suggestions! Empower your MW to provide guidance and identify weaknesses in your plan.
💫 It's brand new! Many Sponsors still do not have a process in place on how to navigate the development of this doc. A MW can help you to brainstorm on a process and set it up!
💫 Content driver constellation is different from other regulatory docs: While the "usually suspects" (functions) are involved, ClinOps is a major content driver of the plan. The Project Management skill of a MW will lead the team to meet the expectations.
Please reach out if you need support with the FDA diversity plan!
Link to contact form or email me.