While randomized trials (RCTs) are required for approval of new medications, these generally exclude pregnant participants. In a CHDS seminar, Alyssa Bilinski discussed a decision-analytic framework to estimate health impacts of avoiding RCTs during pregnancy, from both ex post and a priori perspectives.
Bilinski is the Peterson Family Assistant Professor of Health Policy at Brown University. She notes that over 90 million people in the US — 71% of women aged 18-85 — have given birth at least once. Yet she and her coauthors estimate that fewer than 1% of RCTs enrolled pregnant individuals. Excluding pregnant participants is intended to protect them and their fetuses from adverse effects of new medications. However, avoiding RCTs slows uptake as patients and providers are hesitant to adopt medications with limited evidence, which is detrimental when a medication is beneficial. Nevertheless, if a medication is harmful, more individuals experience adverse events prior to detection in observational studies than in RCTs.
Bilinski examines three salient cases, comparing hypothesized and true benefits and harms: thalidomide (believed helpful but truly harmful); COVID-19 vaccines (believed helpful and truly helpful), and the HIV medication dolutegravir (believed harmful but truly helpful). Her team’s results highlight that conducting well-powered RCTs during pregnancy would improve health outcomes compared to relying upon post-marketing data.
Learn more: Read the article, Fewer Than 1% of United States Clinical Drug Trials Enroll Pregnant Participants
Learn more: Read the article, Sins of Omission: Model-Based Estimates of the Health Effects of Excluding Pregnant Participants from Randomized Controlled Trials
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