How Clinical Pharmacology Can Support Clinical Trial Diversity and Inclusion.

Enrolling diverse populations during early clinical trial development and planning for diversity plans could be challenging. In 2024, the Diversity and Inclusion Clinical Pharmacology Leadership Group Working Group (D&I CPLG WG) from The International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) collaborated with the American Society for Clinical Pharmacology and Therapeutics (ASCPT) to develop a pre-conference session with speakers from industry, regulators, and IQ to utilize clinical pharmacology tools and implement the guidance on diversity plans toward improving the participation of under-represented populations in clinical trials. The pre-conference was well attended by industry, academia, as well as regulators and led to robust presentations and panel discussions through speaker sessions and case studies. The three state-of-the-art lectures and five case studies address key issues concerning the inclusion of underrepresented populations, as well as clinical pharmacology strategies to support the assessment of benefits and risks. The sessions offered insights into clinical pharmacology strategies for evaluating the effects of age, ethnic differences, organ impairment, drug metabolism, transporters, and translational pharmacogenetics approaches in clinical trials. They also highlighted the application of model-informed drug development (MIDD)-based extrapolation to bridge Phase III results to targeted subpopulations, thereby enhancing the efficiency of drug development. Additionally, the diverse formats of this pre-conference, including a hands-on workshop, breakout sessions, and panel discussions, provided an opportunity for the audience to discuss the practicalities of incorporating these principles in drug development settings. This conference reinforced that achieving diversity in clinical trials is a multifaceted challenge that requires sustained efforts across the clinical research ecosystem, guided by a commitment to equity and community engagement. As clinical pharmacologists, we are uniquely positioned to lead this transformation, ensuring future therapies are safe, effective, and equitable for all.