Pregnancy Testing

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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. 

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