Inclusion of Pregnant and Lactating Persons in Clinical Trials Proceedings of a Workshop (2023) / Chapter Skim
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1 Introduction
1 Introduction
Pages 1-8
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. To address the lack of safety and effectiveness information on medi cations used by pregnant and lactating persons, the 21st Century Cures Act established a Task Force on Research Specific to Pregnant Women and 1 This workshop was organized by an independent planning committee whose role was limited to identification of topics and speakers.
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convene a group of experts to "develop a framework for addressing liability issues when planning or conducting research with pregnant and lactating women."3 Subsequently, the Consolidated Appropriations Act of 2022 provided funding for the National Institute of Child Health and Human Development (NICHD) to sponsor a National Academies consensus study on this topic.4 As a primer for the study, the National Academies' Forum on Drug Discovery, Development, and Translation convened a public workshop on June 16 and 17, 2022, for stakeholders to examine the current state of evidence generation for drug products used by pregnant and lactating persons and discuss barriers and opportunities for including these populations in clinical trials.5 The agenda for this workshop was developed by an independent planning committee to address the established task (Box 1-1)
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BACKGROUND Efforts to Improve Sex and Gender Equity in Health Research Faden stated that the National Academies has been working to improve sex and gender equity in health research for nearly 3 decades, and she highlighted three key studies as examples. The 1994 consensus report, Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, made recommendations to improve representation of the health interests of women in the national research agenda and in clinical trials, including recommendations specific to pregnant persons (IOM, 1994)
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project, which was funded by the Wellcome Trust, has worked to develop guidance for the "ethically responsible, socially just, and respectful inclusion of the interests of pregnant women in the development and deployment of vaccines against emerging pathogens."7 The PRGLAC Task Force was established in 2016 under the 21st Century Cures Act and charged with providing advice and guidance to the federal government on "activities related to identifying and address ing gaps in knowledge and research regarding safe and effective therapies for pregnant and lactating persons" (HHS, 2017)
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Ethical Principles That Support Inclusion Maggie Little, senior research scholar and professor of philosophy at the Georgetown University Kennedy Institute of Ethics, discussed ways in which the exclusion of pregnant and lactating persons from clinical trials violates the specific moral principles that are the foundation of clinical research. The clinical research enterprise is committed to "protecting the safety of those who use drug products by first assessing them under carefully controlled and regulated conditions of a clinical research trial," she said.
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regulations considered pregnant people to be a vulnerable population,9 a classification that also includes children, prisoners, people with disabilities, and economically or educationally disadvantaged persons. Federal regulations on human subject protection describe vulnerable populations as subjects that are "likely to be vulnerable to coercion or undue influence."10 The perception is often that it is "morally impermissible or anathema" to conduct research in a vulnerable population, Little said.
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The PHASES project focused on improving the evidence base for pregnant persons in the context of HIV and coinfections, and Little discussed ways of applying lessons learned to improve the evidence base for treatment of pregnant and lactating persons in the context of other diseases.11 The HIV research community was an early adopter of including pregnant women in clinical research in an effort to decrease vertical transmission of the virus from pregnant person to child. Little described how a working group conducted consultations across countries and contexts and disciplines, including with people living with HIV, to learn about study designs that would be appropriate and acceptable for pregnant and lactating persons.
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Chapter 3 reviews how the current legal environment affects the inclusion of pregnant and lactating persons in clinical trials, including stakeholder perspectives on regula tory, liability, and approaches to mitigating liability risks. In Chapter 4, researchers discuss lessons learned from two case examples of attempts to conduct clinical studies with pregnant and lactating persons, and it considers opportunities to apply these lessons to bolster evidence gen eration across therapeutic areas.
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