{"title":"Contraception Requirements in Early Clinical Trials: Considerations Towards an Evidence-Based Approach.","authors":"Tatyana Dubich, Ad F Roffel","doi":"10.1007/s40290-025-00555-0","DOIUrl":null,"url":null,"abstract":"<p><p>Enrollment of women of childbearing potential in clinical trials from early stages of drug development allows the gathering of relevant safety and pharmacokinetics data in the representative disease population. However, risk mitigation strategies are needed to ensure the safety of the developing embryo in case of unintended pregnancy in female study participants or in female partners of male study participants. These risk mitigation strategies often include contraception requirements, however we observed that such requirements vary widely across sponsors and trials. Some sponsors and contract research organizations adhere to the strictest precautions by default, assuming a worst-case scenario for each new compound's risk assessment. In this review, we provide an overview of the risks addressed by and introduced by contraception requirements in clinical trials. We critically discuss the 'worst-case' approach, and we present a holistic, risk-based approach that takes into account all relevant data, the pros and cons of using hormonal contraceptives, and subject burden.</p>","PeriodicalId":19778,"journal":{"name":"Pharmaceutical Medicine","volume":" ","pages":"5-17"},"PeriodicalIF":3.1000,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pharmaceutical Medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1007/s40290-025-00555-0","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/2/22 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"PHARMACOLOGY & PHARMACY","Score":null,"Total":0}
引用次数: 0
Abstract
Enrollment of women of childbearing potential in clinical trials from early stages of drug development allows the gathering of relevant safety and pharmacokinetics data in the representative disease population. However, risk mitigation strategies are needed to ensure the safety of the developing embryo in case of unintended pregnancy in female study participants or in female partners of male study participants. These risk mitigation strategies often include contraception requirements, however we observed that such requirements vary widely across sponsors and trials. Some sponsors and contract research organizations adhere to the strictest precautions by default, assuming a worst-case scenario for each new compound's risk assessment. In this review, we provide an overview of the risks addressed by and introduced by contraception requirements in clinical trials. We critically discuss the 'worst-case' approach, and we present a holistic, risk-based approach that takes into account all relevant data, the pros and cons of using hormonal contraceptives, and subject burden.
期刊介绍：
Pharmaceutical Medicine is a specialist discipline concerned with medical aspects of the discovery, development, evaluation, registration, regulation, monitoring, marketing, distribution and pricing of medicines, drug-device and drug-diagnostic combinations. The Journal disseminates information to support the community of professionals working in these highly inter-related functions. Key areas include translational medicine, clinical trial design, pharmacovigilance, clinical toxicology, drug regulation, clinical pharmacology, biostatistics and pharmacoeconomics. The Journal includes:Overviews of contentious or emerging issues.Comprehensive narrative reviews that provide an authoritative source of information on topical issues.Systematic reviews that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by PRISMA statement.Original research articles reporting the results of well-designed studies with a strong link to wider areas of clinical research.Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Pharmaceutical Medicine may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.All manuscripts are subject to peer review by international experts. Letters to the Editor are welcomed and will be considered for publication.
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