Focus Area: Clinical Trials & Research

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Abstract:

There is widespread recognition, including among pregnant and lactating people, of the need for better evidence on which to base medical treatment decisions during pregnancy and the post-partum period. Despite this, pregnant and lactating people continue to be left out of clinical trials that test drugs, vaccines, devices, and other medical products for safety and efficacy. Study eligibility criteria routinely exclude both pregnant and lactating individuals, even though the biological bases for exclusion of the two populations differ; the effects of exposure of medicinal products to the fetus at the varying stages of development differ from the effects on the neonate or newborn of medicinal products possibly transferred through breast milk Eligibility often requires negative pregnancy tests prior to enrollment and effective methods of contraception for the duration of the study. Further, people who become pregnant while on an interventional trial protocol are typically withdrawn from further participation. Explanations for this are likely to involve perceived ethical, regulatory, and/or legal considerations, reflecting primarily a concern to avoid harming the developing fetus. In the United States, the regulatory framework requires special protections that must be met before pregnant people may participate in clinical research, including limits on the risks they may be asked to undertake. And there are no federal regulations on the exclusion of or additional safeguards for lactating people, despite their common exclusion. In addition, concerns about potential liability and negative public perception are likely to loom large for sponsors, funders, and investigators, motivating them toward the perceived safer strategy of excluding pregnant people from research in many situations.    

At the next Bioethics Collaborative, we will examine ethical issues that bear on determining the proper scope of efforts to further the inclusion of people who are pregnant or lactating in clinical research. Discussion will seek to build on prior workshops and recommendations asking such questions as: Is the current default of excluding pregnant and lactating people from interventional clinical trials justifiable? Do pregnant people have the right to autonomously choose what level of risk is acceptable for themselves and the fetus they carry? How do clinical research entities circumscribe a reasonable range of, and limits on, risk for pregnant people in research, and does this definition align with the views of pregnant and lactating people? Are there alternatives to including pregnant people in clinical trials that can yield the data needed to improve the care of pregnant and lactating people and avoid the well-known problems that arise with seeking to protect groups by excluding them? What are the justice-based implications of placing restrictions on pregnancy? Might requirements for effective contraception, for example, inadvertently function to discourage or even preclude participation from people who are unable to afford contraception? Could these requirements, which are likely to be perceived as burdensome by some, hinder the participation of people of childbearing potential generally and further exacerbate gender inequities in clinical research? We will seek to examine these questions and others on March 8. 

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Deliverables

Meeting Summary

Released on: March 8, 2024

Developed by: MRCT Center Bioethics Collaborative

Advancing Inclusion: Integrating Pregnant and Lactating People in Research – The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard