Bridging disciplinary siloes: a scoping review on the inclusion and exclusion of pregnant and lactating populations in clinical research.

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.