JULY 15, 2013 TO JULY 16, 2013

CTTI Project: Pregnancy Testing

Meeting Background:

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.

Meeting Objectives:

• 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

Meeting Location:

DoubleTree by Hilton Hotel, Bethesda, MD

Meeting Materials:

Meeting Summary

Meeting Agenda

List of meeting attendees

Meeting Presentations:

Day 1

• Welcome by Sara Calvert
• Origin and Rationale of the Project, “Developing Rational Guidance for Pregnancy Testing in Clinical Trials” by Evan R. Myers
• Why do we worry about pregnancy testing? – Teratogens and Teratogenic Risk by Melissa S. Tassinari
• The Analytical & Clinical Complexities of Measuring hCG by Ann M. Gronowski
• What does having a FDA cleared pregnancy test mean? by Denise Johnson-Lyles
• Pharmaceutical Industry Process for Selecting a Pregnancy Testing Protocol by Sheila Ronkin
• Summary of Results from CTTI Pregnancy Testing in Clinical Trials Survey by Evan Myers
• Modeling Approach Background and Initial Simulation Results - Potential Resources/Tools to Guide Selection of Pregnancy Testing Protocols by Evan Myers

Day 2

• Summary of Day 1 Recommendations for Designing and Evaluating Pregnancy Testing Protocols by Evan Myers
• Next Steps by Evan Myers