Through recent actions, the US Food and Drug Administration (FDA) has signalled its commitment to advancing research in pregnant and lactating people, recognising that data is needed to inform labelling and benefit-risk determinations. To this end, the agency collaborated with the Duke University Robert J. Margolis Center for Health Policy to convene a February 2021 public meeting about scientific and ethical issues associated with enrolling pregnant individuals in clinical trials for drug development. Julie Odland at Clarivate explains the scientific and ethical issues surrounding the enrolment of pregnant people in clinical trials.
‘Scientific and Ethical Issues Surrounding the Enrolment of Pregnant People in Clinical Trials’
The US Department of Health and Human Services (HHS) Federal Policy for Protection of Human Research Subjects (45 Code of Federal Regulations [CFR] 46, subpart A) – also called the Common Rule – has removed a reference to pregnant people as “vulnerable.” The FDA is working to harmonise its regulations with the Common Rule, as noted in the October 2018 Guidance for Sponsors, Investigators, and Institutional Review Boards: Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations (Final).
The meeting supported the objectives of the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC). The PRGLAC advises the secretary of the HHS on gaps in knowledge about and research on safe, effective therapies for pregnant and lactating individuals.
Labelling information for pregnant people typically is based on nonclinical data, “with or without limited human safety data,” the FDA states in its April 2018 Draft Guidance for Industry: Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials. Lack of information based on clinical data can mean providers and patients decide against treating underlying conditions, “which in some cases may result in more harm” to the parent and the foetus than if they had received treatment. In other cases, individuals who use medically necessary drugs may do so without understanding the benefits and risks to themselves or their foetuses.
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