Sins of Omission: The Cost of Avoiding Clinical Trials during Pregnancy
Abstract
Randomized controlled trials (RCTs) of drugs almost always exclude pregnant participants. While the intention is to insulate pregnant individuals from harmful side effects, this approach both slows drug uptake, which is costly when a drug is beneficial, and yet simultaneously requires more individuals to experience side effects before detection, which is costly when a drug is harmful. We develop a framework for comparing RCTs to observational trials both in terms of lives saved and fiscal costs.We quantify the costs in life-years of avoiding RCTs with pregnant participants, both in terms of the expected a priori and observed value of information. Across studied indications, we estimate that avoiding clinical trials during pregnancy cost between $255 million and $1.8 billion. In each case, the expected value of information would have justified at least a $100 million trial.