Left Behind No More: Ensuring Therapeutic Advances Benefit Pregnant and Breastfeeding Women
Pregnant women remain the last therapeutic orphans in drug development and optimization. Pregnant women get sick and sick women get pregnant- yet we don’t typically have data to support treatment decisions by women and their providers because pregnant women are largely excluded from clinical trials and systematic evaluation of drugs in pregnant persons. Exclusion of pregnant women from therapeutic trials often does not follow a complex risk-benefit calculus that considers the risks and benefits to both fetus and mother & also from liability concerns by industry, insurers, ethics boards. Pregnancy may shift one’s risk for a disease, disease manifestations, and response to therapies, and so it’s important to study medications in this target population (avoiding terms ‘vulnerable’ or ‘special’ populations), in addition to the basic minimum of garnering exposure (PK) data across the pregnancy-to-postpartum spectrum. Preclinical development and reproductive toxicity (DART) studies are required prior to using new drugs in pregnant and breastfeeding women, but they are expensive, imperfect in their informativeness, and typically not prioritized owing to their costs; thus they are not typically done in time to allow for pregnant women to enroll in Ph2/3 trials. Many groups are working actively on these issues. From a clinical pharmacology and pharmacometrics standpoint, there are already many tools. ASCPT, with its membership of industry/government/academicians can be at the forefront of change in this arena.
