Module232025

07/05/2025

Lactation studies – target populations

FDA Draft Guidance on Clinical Lactation Studies: Considerations for Study Design Guidance for Industry identifies 4 categories of women who may be considered for trials: women who have already decided to take a medically-necessary drug while breastfeeding and continue breastfeeding while taking the drug. women currently breastfeeding and commence a trial must discontinue for the duration of the trial because exposure to the drug is a research risk (offering no clinical benefit to the infant). breastfeeding women who agree to temporarily pump and discard milk to avoid exposing an infant to the investigational drug can be enrolled. breastfeeding women who are healthy volunteers and are administered the investigational drug for the purpose of clinical research must be discontinued for the duration of the study. So, in 3 of the 4 options, the trial requires breastfeeding to be stopped, yet breastfeeding is best for the child – so how is this ethically-acceptable (the needs of the individual always take precedence over those of science and society)? And a 5 th group exists: women who have decided NOT to breastfeed.

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Pregnancy and Lactation studies – survey data 12

Of 654 respondents, 40.9% reported being likely or extremely likely to participate in a clinical trial for a new medication whilst lactating. Chronic medical conditions were associated with a greater likelihood of participation in clinical trials for vaccines during lactation. The most cited motivator for participation in a clinical trial while lactating was anticipated personal medical benefit (75.6%). The primary deterrent was possible risk to the foetus or baby (97.9% and 97.2%, respectively).

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