Designing a pregnancy testing protocol for a clinical trial requires balancing the performance characteristics of a given test, the baseline risk of pregnancy in a given subject population, the potential risks to the fetus from study interventions, and the effect of the testing protocol on overall study implementation in terms of burden to subjects, burden on staff, and direct costs. There are no published data on the consistency of sponsors, investigators, or institutional review boards (IRBs) in applying these criteria to designing and evaluating pregnancy testing protocols. However, anecdotal reports indicate that there is widespread variability.
Development of evidence-based guidance that explicitly considers the level of acceptable risk to suggest appropriate pregnancy testing protocols will ultimately improve protection of research subjects, reduce the risk of unintended fetal exposure, and reduce the workload of sponsors, investigators, IRBs, and other stakeholders in the clinical trial enterprise.
Present survey findings and computer simulation model results from the CTTI project entitled, Developing Rational Guidance for Pregnancy Testing in Clinical Trials
Discuss practices and challenges in assessing the acceptable risk of pregnancy and implementing a pregnancy testing protocol for a clinical trial
Solicit additional feedback and develop consensus on factors to consider when assessing acceptable risk of pregnancy in clinical trials
*The views and opinions expressed in this presentation are those of the individual presenter and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenter is employed or affiliated.