Maggie Little Discussed the Scientific and Ethical Considerations when Designing Clinical Trials that Enroll Pregnant People at the Duke University’s Center for Health Policy
Maggie Little was part of the panel discussion around the Scientific and Ethical Considerations when Designing Clinical Trials that Enroll Pregnant People, which took place on February 2, 2021, as part of the two-day public meeting on the Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials, organized by the Robert J. Margolis, MD, Center for Health Policy at Duke University, under a cooperative agreement with the U.S. Food and Drug Administration (FDA).
The discussion panel addressed the significant challenges that persist to conducting clinical trials in pregnant people, despite the ethical obligation and scientific considerations of conducting these trials. Ethical considerations center on the need to provide effective medical treatment to pregnant people, to protect the fetus while administering such treatments, to prevent harms due to physician reluctance to prescribe treatments because of a dearth of information about treatment safety and efficacy, and to address concerns about fair access to research. As for scientific considerations, the physiological changes throughout pregnancy can impact a drug’s pharmacokinetics resulting in clinically meaningful differences in treatment outcomes, highlighting the need for pharmacokinetic studies in pregnancy. Clinical researchers also need to consider that the potential for toxic fetal exposure to drugs can vary across the course of gestation. In the historical example of thalidomide, a dose that induced severe birth defects early in pregnancy had little to no effect on the fetus if administered later in pregnancy. Discussion in this session outlined factors that impact decisions to evaluate certain therapies during pregnancy, including ethical considerations, unmet need, and risk-benefit analyses. Additionally, the discussion covered dose-finding trial designs as well as the need for long-term safety follow-up studies in children.
Watch the recording: