Overview
Pregnant women have traditionally been excluded from clinical research – however, until now, there were no guidelines for planning for pregnancy testing in clinical trials.
Sponsors, investigators, and institutional review boards can now use CTTI’s recommendations to develop and review pregnancy testing plans, assess the benefits and burdens of various options, and calculate how many participants may potentially enroll while pregnant or become pregnant during the study by using CTTI’s Pregnancy Testing Outcomes Predictor for Clinical Trials.
The recommendations and interactive web application provide a standard way to plan for and make decisions about pregnancy testing in clinical trials, while also improving communication and transparency with trial participants.
Solutions
Search AllRecommendation Summary
Recommendations
Resources
Related Items
- Evidence-based pregnancy testing in clinical trials: Recommendations from a multi-stakeholder development process
- How Improved Pregnancy Testing Planning Can Lead to Safer, More Efficient Clinical Trials
- CTTI Addresses Pregnancy Testing Challenges in Clinical Trials with New Recommendations and Online Tool
- Pregnancy Testing in Clinical Trials Expert Meeting
News
- CTTI Article Outlines Recommendations for Pregnancy Testing in Clinical TrialsMost clinical trials exclude pregnant women in order to minimize risk to the embryo or fetus. However, there are currently no specific guidelines for how pregnancy testing should be conducted ...