FDA Drafts Guidance on Diversity in Clinical Trials

## FDA's New Guidance Aims to Boost Diversity in Clinical Trials

In early 2024, the Clinical Trial Arena’s global Outsourcing in Clinical Trial (OCT) Conference series heavily focused on the need for increased diversity in clinical trials. The 11th Annual OCT UK & Ireland conference, held on June 11-12, 2024, extensively discussed transparency in clinical trials, particularly regarding diversity metrics.

Andrew Ustianowski, a representative from the National Institute for Health and Care Research, emphasized the inadequate access to crucial global data for those striving to improve diversity in trials, underscoring the necessity for mandatory disclosure in legislation. The consensus was that transparency on diversity and other trial metrics is vital for advancing the industry and ensuring accountability.

Shortly after, the FDA released its draft guidance on Diversity Action Plans, aimed at enhancing the enrollment of underrepresented populations in clinical trials. Sponsors are now required to provide detailed enrollment goals and strategies for diverse participants, categorized by age, sex, and race.

Surprisingly, GlobalData's statistics show that only approximately 8.6% of clinical trials disclose the race of participants, indicating minimal change over the years. The timely FDA guidance could significantly elevate the visibility and inclusion of diversity data in trials. This regulation is anticipated to stimulate a substantial shift towards more inclusive and transparent clinical research.

### Key Takeaways
- FDA issues guidance on clinical trial diversity plans.
- Sponsors must detail enrollment goals by age, sex, and race.
- Transparency on diversity metrics is crucial for industry accountability.
- Only 8.6% of trials currently disclose participant race data.
- FDA allows waivers for Diversity Action Plans under certain conditions.

### Analysis
The FDA's new guidance on clinical trial diversity plans, requiring sponsors to detail enrollment goals by age, sex, and race, aims to enhance transparency and accountability. This move could significantly impact pharmaceutical companies, mandating changes in recruitment strategies and data collection, potentially leading to more effective and safer treatments, and bolstering public trust in the industry.

### Did You Know?
- **Diversity Action Plans (DAPs)**:
  - **Explanation**: Mandated by the FDA for clinical trial sponsors to outline specific goals and strategies for enrolling a more diverse participant base in trials, segmented by age, sex, and race.
- **Outsourcing in Clinical Trial (OCT) Conference**:
  - **Explanation**: A global event focused on the latest trends and innovations in the clinical trial industry, bringing together professionals from various sectors to discuss and strategize on improving clinical trial processes.
- **Mandatory Disclosure in Legislation**:
  - **Explanation**: The requirement for clinical trial sponsors to publicly report specific data and metrics related to their trials, particularly diversity metrics, aimed at increasing transparency and accountability within the industry.