Pregnancy testing is necessary in clinical trials if there is a possibility of pregnancy in the study population and embryo/fetal exposure to the study treatment poses a known or unknown risk. However, there is little formal guidance on how pregnancy testing should be conducted to prevent unintended exposure, nor how risks should be clearly communicated to women.

CTTI’s new recommendations help research sponsors, investigators, and institutional review boards develop and review pregnancy testing plans, in an effort to conduct safer, more efficient clinical trials. CTTI also created the Pregnancy Testing Outcomes Predictor for Clinical Trials, a web application that provides a quantitative method for assessing estimated likely outcomes of different pregnancy testing plans.

A webinar recording is now available detailing the new recommendations and web application, including case examples of their use.

View the webinar recording to learn:

• Steps involved in proactive planning for pregnancy testing before the start of a clinical trial
• A new web application to help assess the balance of benefits and burdens of specific pregnancy testing plans
• Ways study coordinators can improve communication so that women receive clear, comprehensive information before joining a clinical trial
• How these new recommendations promote the safe inclusion of women in clinical trials

Visit this page for presenter information and to download a copy of the slides.