Diversity and Equity in Clinical Trials: Pharmacokinetic Variability, Metabolism, and Transport

Clinical trials should generate evidence that is applicable to the diverse populations who will ultimately receive new medicines. However, pharmacokinetic variability arising from intrinsic factors such as genetics, age, sex, body composition, organ function, and pregnancy, as well as extrinsic factors including diet, concomitant medications, and environmental influences, remains insufficiently characterized for many populations. Many clinical trials continue to underrepresent older adults, children, pregnant women, individuals with organ impairment, diverse ancestral backgrounds, and populations from low- and middle-income countries, limiting the generalizability of pharmacokinetic data and evidence-based dosing recommendations. Regulatory authorities increasingly emphasize the need for representative clinical trial populations and robust evaluation of factors influencing drug metabolism, transport, and exposure to support evidence-based dosing and improve benefit-risk assessments.This Research Topic aims to advance understanding of sex- and gender-related differences in drug development and clinical outcomes, with particular emphasis on evidence generated after regulatory approval. In line with the scope of this section, we particularly invite manuscripts addressing post-approval conditions, including post-marketing surveillance, real-world pharmacokinetic variability, and outcomes research conducted after regulatory approval. We welcome original research, systematic reviews, modelling approaches, pharmacogenomic studies, and regulatory perspectives that improve the characterization of intrinsic and extrinsic factors influencing drug exposure. By promoting inclusive study designs, innovative quantitative methodologies, and globally relevant evidence generation, this collection seeks to support precision dosing, strengthen regulatory decision-making, and contribute to more equitable access to safe and effective medicines for patients worldwide.This Research Topic welcomes the following types of contributions:- Original research, systematic reviews, mini-reviews, perspectives, and methods papers exploring pharmacokinetic variability and its implications for diversity, equity, and precision medicine in clinical drug development.- Contributions addressing intrinsic and extrinsic determinants of drug absorption, distribution, metabolism, transport, and elimination, including pharmacogenomics, transporter biology, drug–drug interactions, population pharmacokinetic and physiologically based pharmacokinetic (PBPK) modelling, and model-informed drug development.- Submissions focusing on underrepresented populations, including paediatric, geriatric, pregnant, and patients with renal or hepatic impairment, as well as ethnic and ancestral diversity, are particularly encouraged.- Manuscripts on innovative trial designs, regulatory science, diversity action plans, real-world evidence, and digital approaches that enhance equitable evidence generation and support globally applicable dosing strategies.- Interdisciplinary contributions spanning basic science, translational research, clinical pharmacology, and regulatory science are strongly encouraged.- Ethics, equity, and representativeness in clinical trials, including the inclusion and protection of vulnerable, Indigenous, and historically underrepresented populations.Topic Editor Dr. Ghazaleh Gouya Lechner is the owner of Gouya Insights GmbH & Co. KG and holds a 2.5% share in ProFem GmbH. Topic editors: Kotone Matsuyama, Ghazaleh Gouya-Lechner, Eric Klaver Source: https://www.frontiersin.org/research-topics/86541/diversity-and-equity-in-clinical-trials-pharmacokinetic-variability-metabolism-and-transport