Liao Michael Z, Sawant Aarti, Corrigan Brian, Haertter Sebastian, Otsubo Yasuto, Younis Islam R, Kasichayanula Sreeneeranj, Mehta Rashmi
Genentech, Inc., South San Francisco, California, USA.
Clinical Pharmacology and Pharmacometrics, AstraZeneca, Waltham, Massachusetts, USA.
Clin Transl Sci. 2025 Sep;18(9):e70332. doi: 10.1111/cts.70332.
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.
在早期临床试验开发阶段纳入多样化人群并制定多样性计划可能具有挑战性。2024年，药物研发创新与质量国际联盟（IQ）的多样性与包容性临床药理学领导小组工作组（D&I CPLG WG）与美国临床药理学与治疗学学会（ASCPT）合作，举办了一场会前会议，邀请了来自行业、监管机构和IQ的演讲者，以利用临床药理学工具并实施多样性计划指南，从而提高代表性不足人群参与临床试验的比例。该会前会议受到了行业、学术界以及监管机构的广泛关注，并通过演讲环节和案例研究引发了精彩的演讲和小组讨论。三场前沿讲座和五个案例研究探讨了与纳入代表性不足人群相关的关键问题，以及支持效益和风险评估的临床药理学策略。这些会议深入探讨了在临床试验中评估年龄、种族差异、器官损害、药物代谢、转运体和转化药物基因组学方法影响的临床药理学策略。它们还强调了基于模型的药物开发（MIDD）外推法在将III期结果推广至目标亚群方面的应用，从而提高药物开发效率。此外，本次会前会议的多种形式，包括实践工作坊、分组讨论和小组讨论，为听众提供了一个讨论在药物开发环境中纳入这些原则的实际操作的机会。本次会议强调，在临床试验中实现多样性是一项多方面的挑战，需要临床研究生态系统各方持续努力，并以公平和社区参与为导向。作为临床药理学家，我们处于独特的地位来引领这一变革，确保未来的治疗方法对所有人都是安全、有效且公平的。
