Traditionally, pregnant women have been excluded from clinical trials for a number of reasons. This has led to a lack of information about medication risks to pregnant women and growing foetuses, most recently in developing ways to deal with COVID-19. The FDA has recently promoted the inclusion of pregnant women in trials, however there are obvious challenges which need to be addressed before that can happen.
In February 2021, the Duke-Margolis Center for Health Policy, under a cooperative agreement with the FDA, conducted a public meeting that discussed the ethical, legal and scientific considerations for including pregnant women in clinical trials. This meeting was attended by academics, government agencies, industries, and patient advocacy groups.
From a scientific point of view, the convention discussed the fact that non clinical and clinical data are essential components of the drug development progress – non-clinical providing safety information essential to determining dosage, eligibility criteria, and drug labelling; clinical in assisting in decision-making and care delivery. In relation to pregnant women, the convention discussed two types of non-clinical study regarding developmental toxicity and reproductive toxicity. They also outlined that the primary goals of clinical trials which include pregnant women is to develop therapeutics for pregnancy-related conditions including preeclampsia and preterm birth.
From an ethical point of view, it was felt the exclusion of pregnant women had been previously guided by a protectionist ethic which failed to acknowledge that all research might not have direct benefit to participants at the time, however could have a future positive impact. The ethics surrounding unnecessary use of contraception in certain cases was also discussed. The convention participants emphasised that a strong ethical framework must be in place and that patients recruited must be protected throughout the research process.
Legal considerations were also discussed, concluding that legal experts must be engaged throughout the drug development process to ensure that effective risk mitigation is in place.
It’s likely and probable that pregnant women will, in future, be included more in clinical studies. A proper framework can accelerate the process, and utilising existing data including electronic health records and trial infrastructure can also help. Done carefully and ethically, and with the consideration of patients and foetuses remaining paramount, the future of health for pregnant women worldwide looks set to improve over time.
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