Associate Director Janssen Research & Development, United States
Background: Due to the exclusion of pregnant and lactating persons from most clinical trials, there is an incomplete understanding of the risks and benefits of medication use in these populations and therapeutic decision-making is often conducted without adequate evidence. To change this paradigm and increase inclusion, an understanding of the perspectives of pregnant and lactating persons regarding participation in clinical trials is needed.
Objectives: To describe attitudes, perceptions, barriers, and preferences of pregnant and postpartum people in the United States (US) regarding participation in clinical trials and to identify factors influencing participation.
Methods: In November 2022, individuals self-identifying as pregnant or pregnant within the last 12 months who were 18 years or older and resided in the United States (US) were invited to complete an online survey about their perspectives regarding clinical trial participation. Survey questions included demographic characteristics, health history and behaviors, and opinions about willingness to participate in a clinical trial while pregnant and/or lactating. Multivariable logistic regression models were fit to identify predictors of clinical trial participation.
Results: Of the 654 respondents, 34.8% and 40.9% reported that they would be likely or extremely likely to participate in a clinical trial for a new medication while pregnant or lactating, respectively; and 24.5% and 41.7% for a new vaccine while pregnant or lactating, respectively. Greater educational attainment (≥Bachelor’s degree) was associated with a greater reported likelihood of clinical trial participation in pregnancy (odds ratio (OR)=1.36, 95% Confidence Interval (CI): 0.93, 2.01 for a medication and OR=2.06, 95% CI: 1.34, 3.18 for a vaccine). Chronic medical conditions were associated with a higher likelihood of participation in a clinical trial for a vaccine while lactating (OR=1.70 (95% CI: 1.15, 2.51). The most commonly cited motivator for participation in a clinical trial while pregnant or lactating was anticipated personal medical benefit (83.5% and 57.7%, respectively) and deterrent for participation was possible risk to the fetus or baby (97.9% and 74.9%, respectively).
Conclusions: Willingness of a US sample to participate in clinical trials while pregnant or lactating varied by demographics and health status, with safety to the fetus being a nearly ubiquitous concern. This information has important implications for inclusion efforts for pregnant and lactating people in clinical research and effective and equitable recruitment strategies.
