Sins of Omission: Model-Based Estimates of the Health Effects of Excluding Pregnant Participants From Randomized Controlled Trials | Annals of Internal Medicine
Background: More than 90 million women in the United States have given birth. Randomized controlled trials (RCTs) of medications almost always exclude pregnant participants. Objective: To quantify the health effects of excluding pregnant participants from RCTs. Design: Decision analytic framework applied to case studies of thalidomide, COVID-19 vaccines, and dolutegravir. Setting: Varied. Participants: Pregnant people and their children. Measurements: The authors modeled the ex post facto health effects of RCTs, comparing projected health effects of medication uptake had an RCT been conducted versus historically observed outcomes. They also modeled the a priori health effects that could have been anticipated in trial planning. They converted health effect estimates to monetary value using standard benchmarks. Results: Across case studies, health benefits from conducting RCTs during pregnancy were projected to far exceed expected adverse effects (AEs) from RCTs. For example, had thalido
