Evidence-based pregnancy testing in clinical trials: Recommendations from a multi-stakeholder development process.

ABSTRACT: Most clinical trials exclude pregnant women in order to avoid the possibility of adverse embryonic and/or fetal effects. Currently, there are no evidence-based guidelines regarding appropriate methods for identifying early pregnancy among research subjects. This lack of guidance results in wide variation in pregnancy testing plans, leading to the potential for inadequate protection against embryonic or fetal exposure in some cases and unnecessary burdens on research participants in others, as well as inefficiencies caused by disagreements among sponsors, investigators, and regulators. To address this issue, the Clinical Trials Transformation Initiative convened content experts and stakeholders to develop recommendations for pregnancy testing in clinical research based on currently availabl

SUBMITTER: Morse JE 

PROVIDER: S-EPMC6135366 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature