CTTI_Pregnancy_Testing_Project_Protocol v1

Pregnant women are excluded from many, if not most, clinical trials. Although there are several potential scientific justifications for this exclusion (such as the often unknown effects of the normal physiological changes of pregnancy on drug metabolism), the primary rationale is to minimize the risk of adverse fetal effects from exposure to study-related interventions. Little formal guidance is available on how to develop pregnancy testing plansfor clinical trials. To address this issue, the Clinical Trials Transformation Initiative (CTTI) conducted a project - which included an online survey, a quantitative model, and a meeting of content experts and stakeholders - to develop recommendations for pregnancy testing in clinical research based on currently available evidence. This protocol describes the project methods.