Enhancing inclusivity in clinical trials: Model‐informed drug development for pregnant individuals in the era of personalized medicine.

The article discusses the underrepresentation of pregnant individuals in clinical trials and drug development programs, leading to a lack of safety and efficacy data for this population. It highlights the importance of model‐informed drug development (MIDD) tools and early engagement between pharmaceutical companies and regulatory agencies. The use of physiologically-based pharmacokinetic (PBPK) modeling, toxicology modeling, quantitative systems pharmacology, real-world data, and machine learning are proposed as methods to enhance drug development for pregnant individuals. Efforts to improve inclusivity in clinical trials for pregnant individuals are ongoing, with regulatory agencies emphasizing the need for postmarketing required (PMR) studies to gather essential information. [Extracted from the article]