Inclusive clinical trials: an oxymoron?

AI Briefing

• – Pregnant and breastfeeding women are not included in pivotal clinical trials due to concerns about bias and errors, and subgroup analyses may lead to spurious results. The lack of data on pregnancy safety for many drugs is a major issue, with only a dozen REMS strategies issued by the US FDA for teratogenic drugs. Inclusion of these women in trials is seen as driven by sentiment rather than reasoning.