ArticleEthics & human research
Exclusion of Women from Phase I Trials: Perspectives from Investigators and Research Oversight Officials.
Article in Ethics & human research. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 3 of them syntheses that pooled it.
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
14 citing papers in PubMed, 3 syntheses or guidelines pooled it, 15 citations in OpenAlex.
- Effectiveness of Alcohol Use Disorder Pharmacotherapies by Sex: Systematic Review and Meta-Analysis.Drug and alcohol review · 2026Pooled it
- Female participation in randomized controlled trials of motor rehabilitation after spinal cord injury: a systematic review.Spinal cord · 2026Pooled it
- Lack of diversity in antifibrotic trials for pulmonary fibrosis: a systematic review.European respiratory review : an official journal of the European Respiratory Society · 2025Pooled it
- Equity and Respect in Maternal and Infant Healthcare-A Report From the 2025 Venice Forum.Acta paediatrica (Oslo, Norway : 1992) · 2026Review
- Queer Science and Scientists Are Shaping the Future of Immunology.European journal of immunology · 2026Article
- Vaginal microbiomes and their pertinent social context: a microbial ecological review proffering AMR-STI acquisition and emergence.Biology of sex differences · 2026Review
- Quantification of Age and Sex Ratio Differences between Trial and Target Population for New Drugs.Clinical pharmacology and therapeutics · 2026Article
- Early control or gradual relief? Gender-specific real-world insights into omalizumab response in chronic spontaneous urticaria patients.The World Allergy Organization journal · 2026Article
- Aging reveals divergent responses of AgRP/NPY neurons to diet in male and female mice.bioRxiv : the preprint server for biology · 2025Article
- Tracking a decade of phase I clinical trials in Italy: trends and insights from national and european registries amid regulatory change.Frontiers in pharmacology · 2025Article
- An international questionnaire highlights and supports the case for including girls in Creatine Transporter Deficiency research.Frontiers in neuroscience · 2025Article
- Enrollment of Females in Randomized Trials for Glucagon-Like Peptide 1 Receptor Agonists: A Systematic Review.JACC. Advances · 2024Article
- Key role of adsorption site abundance in the direct electrochemical co-detection of estradiol and dopamine.Discover nano · 2024Article
- Toward demographic robustness in digital patient twins: Addressing the gender data gap.Digital healthArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 1 institution in 1 country.
Funding
Abstract
Over the past 30 years, progress has been made in increasing women's representation in clinical research. However, women continue to be underrepresented in phase I clinical trials-those trials that test the safety and tolerability of investigational drugs, often on healthy individuals. As sex-based differences in adverse drug reactions are often linked to drug dose, pivotal safety information in phase I trials is often insufficiently-and inequitably-captured for females. Yet there has been little attention to how clinical investigators and those charged with overseeing the ethical conduct of these trials perceive the barriers to women's inclusion in phase I trials. To address this gap, we report on 22 interviews with U.S. phase I investigators and institutional review board (IRB) members. Our findings indicate that although these investigators and IRB members acknowledged the importance of including women in clinical trials, they justified women's exclusion from phase I trials by citing the need to manage their reproductive potential. In particular, we identified four key themes that informants used to warrant women's exclusion from phase I trials: the structure of the drug-development system itself, fears about risks to potential fetuses, distrust of women to prevent pregnancy, and concerns about risks and burdens to institutions from resulting pregnancies. We argue that these rationales reflect structural and cultural barriers to women's inclusion in clinical research that ultimately fail to respect female research participants as persons, highlighting the need for broad-based solutions.
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.