Research with Pregnant and Lactating Persons: Mitigating Risk and Liability – A Workshop
The Role of Risk Management & Trial Insurance
Approximately 4 million persons in the United States give birth annually. Over 60% of them are prescribed a medication during their pregnancy for either a chronic condition or one arising from the pregnancy itself. Yet, due to historical events, such as the widely publicized birth defects resulting from exposure to thalidomide during pregnancy, evaluating the safety and effectiveness of drugs in pregnant and lactating persons has been viewed as risky and has not been prioritized. As a result, pregnant and lactating persons are often taking drugs with limited data to inform safety, dosing, and efficacy. This population, as well as their fetuses and breast-feeding infants, is thus often subjected to treatments with uncharacterized risks and harms due to their exclusion from clinical trials. In response to a Congressional request, an ad hoc committee of the National Academies of Sciences, Engineering, and Medicine will conduct a study on the state of real and perceived liability around research conducted in pregnant and lactating persons, and develop a framework for addressing medicolegal and liability issues when planning or conducting research specific to pregnant and lactating persons.
- Sara Dyson, Vice President of Underwriting Operations & Risk Management, Medmarc
- Jamie Wilkins, Senior Director, Risk Management Center of Excellence, Pfizer
- Hillary Noll Kalay, Principal Counsel, University of California
- Elisa Hurley, Executive Director, Public Responsibility in Medicine and Research
SESSION OBJECTIVES AND POTENTIAL DISCUSSION QUESTIONS
- Understand what factors or considerations influence decisions to include or exclude pregnant and lactating populations from clinical research;
- Discuss how risk and benefit are assessed for populations that are being considered for inclusion in a clinical research study, as well as for the institutions conducting, funding, or insuring the study; and
- Examine opportunities to apply risk mitigation strategies to clinical research that includes pregnant and lactating populations.