Advancing Clinical Research with Pregnant and Lactating Populations Overcoming Real and Perceived Liability Risks (2024) / Chapter Skim
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Nonetheless, pregnant and lactating women continue to be excluded from most clinical studies to the detri ment of their health and that of their fetuses and children. Past studies have attributed their exclusion to concerns about legal liability for the investigators and institutions that conduct and sponsor clinical research should research participants, or their fetuses or children, experience nega tive effects from the study intervention.
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Seventy percent of pregnant women take one or more prescription medications during pregnancy, as is also true for at least half of lactat ing women. Pregnant and lactating women are generally excluded from clinical studies; they and their health care providers lack the sort of data about the dosage, efficacy, and safety of medical products that are avail able for other members of the adult population.
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The committee instead thoroughly examined liability for harms alleged to have occurred during clinical research and in the clinical use of licensed medical products. The committee complemented this examination with a discussion of the laws and regulations applicable to clinical research involving pregnant and lactating women in order to explore when and how liability arises.
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This failure also seems to increase the potential liability of the individuals and organizations who manufacture, distribute, and prescribe the medical product without providing dosing, safety, and efficacy information that is relevant to a distinct group of patients who are expected to use the product. That said, manufacturers have generally mitigated this risk through labeling, promotion, and postmarket surveillance in accordance with FDA regu lations and guidance, rather than by including pregnant and lactating women in clinical research.
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The reality is that not conducting research involving pregnant and lactating women has the potential to generate far greater harm arising from treatments and preventives that have not been tested in pregnant and lactat ing women, and thus a greater risk of liability for all those associated with the clinical encounter to the extent that they are found to have violated a duty under applicable state tort law. ABATING LIABILITY BY REDUCING POTENTIAL HARM Harm and liability are interconnected: harm refers to the injury suf fered; liability refers to the legal responsibility for that harm.
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Research sponsors can also design clinical research using innovative methodologies and can increase equity through pragmatic trials and opportunistic studies. MITIGATING POTENTIAL LIABILITY IN CLINICAL INVESTIGATIONS The legal liability that is relevant to the participation of pregnant and lactating women in clinical research is tort liability.
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FACTORS INFLUENCING PERCEPTIONS OF LIABILITY The committee determined that decisions regarding research with pregnant and lactating women are influenced by perceptions of liability that are intertwined with other factors that have contributed to the exclu sion of pregnant and lactating women from clinical studies. When a spon sor or other stakeholder is deciding whether to conduct research with pregnant and lactating women, it evaluates the reasons for and against doing the research -- incorporating considerations related to uncertainties and assessments of legal liability exposure, potential reputational losses, and financial, technical, and practical considerations associated with the PREPUBLICATION COPY -- Uncorrected Proofs A02260_Advancing_Clinical_Research_FM.indd 7 4/4/24 1:47 PM
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Changing one factor, such as offering regulatory predictability or financial incentives, could offset and overcome potential liability con cerns; addressing these interrelated factors together could affect how stakeholders view liability regarding research with pregnant and lactating women. Recommendations The committee drew on public testimony, research, and delibera tions to arrive at nine recommendations to improve the safe and ethical inclusion of pregnant and lactating women in clinical research while mitigating the risk of liability.
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If the product sponsor believes that data from preclinical studies of the product, or evidence concerning the safety of other products in the same class, raises concerns about the potential harm to pregnant and lactating women or their offspring, the sponsor may submit to FDA a justification for not including pregnant or lactating women in the clinical studies outlining the basis PREPUBLICATION COPY -- Uncorrected Proofs A02260_Advancing_Clinical_Research_FM.indd 9 4/4/24 1:47 PM
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If the preclinical data presented in the diversity action plans raises safety con cerns for conducting human trials in pregnant and lactating women, a justification for not conducting clinical studies must be submitted along with the diversity action plan outlining the evidence for concerns. When FDA reviewers agree there are safety concerns regarding clinical testing in pregnant and lactating women, trials are not to be com pleted and the safety information must be included in the drug labeling.
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OHRP should pro vide guidance documents that help clinical researchers, insti tutional review boards (IRBs) , and data and safety monitoring boards ensure that pregnant and lactating women who partici pate in clinical research are adequately protected without creat ing undue burdens for their participation.
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c. Grant the secretary of HHS the authority to make a written request to the patent holder of medical products subject to patent or exclusivity protections to conduct clinical studies involving pregnant and lactating women concerning one or more of the on-patent medical products identified in part (a)
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to identify and characterize risks to pregnant and lactating women and their offspring" as a justification for requiring postmarket ing studies and postmarketing clinical trials.
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The U.S. Department of Health and Human Services should form an interagency task force, including the Food and Drug Administration, National Institutes of Health, Centers for Disease Control and Prevention, Health Resources and Services Administration, Office of the National Coordinator for Health Information Technology, and the National Library of Medicine to create and maintain infrastructure and guidelines for the conduct of postmarketing pregnancy and lactation safety studies that would use safety information, annual status reports from existing pregnancy and lactation exposure registries, and data generated through database studies.
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SUMMARY 15 Recommendation 9. If research being conducted with pregnant individuals, or individuals who may become pregnant over the course of the study, is not already covered by a certificate of confidentiality issued by the National Institutes of Health or other federal agency, the principal investigator of the study should apply to the National Institutes of Health for a certificate of confidentiality.
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PREPUBLICATION COPY -- Uncorrected Proofs A02260_Advancing_Clinical_Research_FM.indd 16 4/4/24 1:47 PM
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