ArticleBMJ public health2026
Bridging disciplinary siloes: a scoping review on the inclusion and exclusion of pregnant and lactating populations in clinical research.
Article in BMJ public health, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Special Populations in Pivotal Clinical Trials: Eligibility and Supporting Evidence for Exclusion in EMA-Authorised Medicines.Clinical pharmacology and therapeutics · 2026Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Objectives: Despite calls for including pregnant and lactating people in clinical research, exclusionary practices persist. Current arguments for inclusion are fragmented and discipline-specific. This scoping review synthesised how inclusion and exclusion of pregnant and lactating populations in clinical research is framed across fields, and identified recommendations for responsible inclusion. Design: Scoping review. Data sources: We searched eight databases from inception to 14 February 2024: MEDLINE, CINAHL, Family & Society Studies Worldwide, SocINDEX, Scopus, Web of Science, Embase and Global Health. Eligibility criteria: Papers about conceptual or empirical issues related to inclusion or exclusion of pregnant and lactating populations in clinical research. Eligible publications included conceptual analyses, reflections on regulatory and ethical guidance, primary research, review articles, commentaries, viewpoints and editorials. Data extraction and synthesis: Two reviewers independently screened and extracted data, developed article summaries and iteratively synthesised findings into themes. Results: We included 188 papers across bioethics, law and regulation, epidemiology, pharmacology and market and product development. We developed 10 themes: (1) narratives of vulnerability, (2) the injustice of exclusion, (3) risk and overprotection, (4) the unique physiology of pregnancy and lactation, (5) business risks in drug development, (6) informed consent and its limitations, (7) evaluating risks and benefits in maternal-fetal therapies, (8) reliance on animal studies for safety data, (9) designing studies for optimal safety and efficacy and (10) the challenges of detecting adverse events. Recommendations highlight early initiation of preclinical studies, consensus on terminology like 'minimal risk', standardised trial endpoints, dedicated funding for research networks, incentives for pharmaceutical companies, capacity strengthening for research ethics committees and partnerships with community-based and patient advocacy organisations. Conclusion: Challenges to the responsible inclusion of pregnant and lactating populations arise across multiple stages of clinical research. Structural changes through coordinated interventions across the research pipeline are needed to change the status quo.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.