How Clinical Pharmacology Can Support Clinical Trial Diversity and Inclusion

Area of Science:

• Clinical Pharmacology
• Drug Development
• Health Equity

Background:

• Enrolling diverse populations in early clinical trials presents challenges.
• Developing diversity plans requires strategic implementation.
• The Diversity and Inclusion Clinical Pharmacology Leadership Group Working Group (D&I CPLG WG) and the American Society for Clinical Pharmacology and Therapeutics (ASCPT) addressed these issues.

Purpose of the Study:

• To develop strategies for improving the participation of under-represented populations in clinical trials.
• To utilize clinical pharmacology tools and guidance on diversity plans.
• To foster collaboration among industry, regulators, and academia.

Main Methods:

• A pre-conference session featuring industry, regulator, and IQ speakers.
• State-of-the-art lectures and case studies on diversity and inclusion in trials.
• Discussions on clinical pharmacology strategies, including model-informed drug development (MIDD) and translational pharmacogenetics.

Main Results:

• The pre-conference successfully engaged industry, academia, and regulators.
• Key issues concerning underrepresented populations and benefit-risk assessment were addressed.
• Insights were provided on evaluating demographic and biological factors (age, ethnicity, organ impairment, metabolism, transporters, pharmacogenetics) in clinical trials.

Conclusions:

• Achieving diversity in clinical trials is a complex challenge requiring sustained, ecosystem-wide efforts.
• Clinical pharmacologists are pivotal in leading the transformation towards equitable drug development.
• A commitment to equity and community engagement is essential for success.