In clinical trials, there are inherent difficulties in investigating the safety of drug exposure to pregnant populations, including any impact on the child (e.g., neurodevelopmental disorders). Ethical concerns surrounding the potential risk of harm to the fetus and legal liability fears often lead to the exclusion of pregnant women from trials, resulting in limited direct evidence for this group at the time of product launch.
Research challenge
Real-world data (RWD) offers the promise of investigating this population by allowing observation of clinical practice—where drug use (especially of routine medical interventions for chronic conditions e.g., migraine) may persist through the period of pregnancy. Even so, many epidemiological and safety studies struggle to capture the full continuum of care from pregnancy through childhood:
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- Fragmented data make it difficult to link parent and child records
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- Limited clinical depth in typical claims databases misses key perinatal variables
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- Short follow-up windows fail to reveal long-term health trajectories
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- Available cohorts may be smaller than the total national population, as linkages between parent and child rely on overlapping data collection periods and catchment areas of different databases
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- Situations like multiple births may be under-represented in child cohorts
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- Outcome rates may be constrained by the fact that medical events can only be identified if they are captured in routine clinical practice
Collectively, these challenges—small sample sizes due to the nature of the population, limited linkage rates, and incomplete outcome capture—require careful methodological consideration to ensure validity and generalizability of findings.
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