ArticleContemporary clinical trials2022
Clinical trials in pregnancy and the "shadows of thalidomide": Revisiting the legacy of Frances Kelsey.
Article in Contemporary clinical trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses that pooled it.
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Who cites it
19 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Synthesizing Cohort Study Results to Promote Knowledge Transfer of Safety Data Regarding Gestational Antidepressant Exposure and Offspring Congenital Anomalies: A Test of Concept.Birth defects research · 2025Pooled it
- A Systematic Patent Review (2008-2023) for Treatment in Pregnancy.Current medicinal chemistry · 2024Pooled it
- Obstetric Pharmacoethics: An ethical framework for obstetric pharmacology.European journal of obstetrics, gynecology, and reproductive biology · 2026Article
- Pharmaceutical policy and off-label prescribing in pregnancy: A population-based historical cohort study analyzing inequality in access to antiemetics within Australia's Pharmaceutical Benefits Scheme.Acta obstetricia et gynecologica Scandinavica · 2026Article
- Connections between science and care within public and global health research: the need for attention and action.Journal of global health · 2026Article
- Bridging disciplinary siloes: a scoping review on the inclusion and exclusion of pregnant and lactating populations in clinical research.BMJ public health · 2026Article
- Mapping the path to diversity in clinical trials: a qualitative study of community member and stakeholder perspectives.BMC public health · 2025Article
- Understudied Populations in Radiation Exposure Research: Needs, Challenges, and Mitigation Strategies.Radiation research · 2025Article
- Overheard at a conference: an in-class activity to foster classroom discussion on ethics and experimental systems in microbiology research.Journal of microbiology & biology education · 2025Article
- The power-and complexity-of policy to drive advances in women's health.Science advances · 2025Review
- Drug safety in pregnancy.Australian prescriber · 2025Review
- Eliminating gender bias in biomedical research requires fair inclusion of pregnant women and gender diverse people.Communications medicine · 2024Review
- Reproductive Intrusions: Evidence and Ethics.The American journal of bioethics : AJOB · 2024Article
- Teratology research in the shadow of the Dobbs decision.Birth defects research · 2023Article
- Raising concerns on questionable ethics approvals - a case study of 456 trials from the Institut Hospitalo-Universitaire Méditerranée Infection.Research integrity and peer review · 2023Article
- The urgent need for conducting clinical trials in pediatric nephrology globally.Pediatric nephrology (Berlin, Germany) · 2023Article
- Pharmacokinetic Research in Pregnancy: Ethical Low-Hanging Fruit?Journal of clinical pharmacology · 2023Article
- Organ Chips and Translational Research: Identifying and Examining New Ethical Issues.Ethics & human researchArticle
- Policies for the Inclusion of Pregnant Women in Research: Results from an International and a US Study.Ethics & human researchArticle
Corrections and comments
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Authors and funding
2 authors.
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Abstract
Despite great need for improved understanding of the use of drugs and biological products in pregnancy, clinical trials in pregnancy are rare, therapeutics in pregnancy are woefully understudied, and pregnant individuals are routinely excluded as trial participants. Recently, however, the U.S. Food and Drug Administration (FDA) has signaled strong support for advancing scientific research with pregnant populations, marking a significant shift from the past. Over the last sixty years, precaution and fear have largely characterized clinical research in pregnancy, deriving in large part from a protectionist ethic that materialized after the thalidomide drug disaster. FDA reviewer Frances Kelsey courageously prevented thalidomide from being marketed in the United States, and her work guided and solidified the FDA's image as protector of the general population from unsafe and ineffective drugs. Yet, when it comes to protection, pregnant persons have been left behind, and experts refer to the "shadows of thalidomide" that hamper clinical trials in pregnancy. Drawing on analysis of Frances Kelsey's archived papers in addition to focused media coverage of Kelsey and thalidomide, we discuss the durable cultural narrative surrounding Kelsey's important work. We argue that revisiting Kelsey's legacy with attention to themes that have characterized her achievement-staying vigilant, prioritizing safety, and mitigating pharmaceutical-based harm-in fact facilitates progress toward the ethical obligation to protect pregnant people through research, toward the generation of pregnancy-specific data for evidence-based care, and toward realizing Kelsey's legacy of safeguarding pregnant people and their offspring from the harms of untested drugs.
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