Here’s a scenario anyone who has done clinical research will recognize: A 32-year-old woman participating in a Phase 1 healthy-volunteer crossover clinical trial tested negative for pregnancy when she enrolled and agreed to use contraception during the course of the trial, as specified in the protocol. After completing the first phase of the trial, she checked in for the second phase, at which time the required pregnancy test was positive.
For good reason, pregnancy tests are a standard part of screening for certain clinical trials. Participants with positive results are excluded from participating to protect them and their developing fetuses from potential harm. For clinical research that includes women of childbearing potential, pregnancy tests are performed at intervals during the trial. Protocols contain language to specify how to follow participants who inadvertently become pregnant during a study and procedures have been established to execute those protocols.
Balancing the need to have representative, diverse clinical trials with mitigating the risk of exposing a fetus to an experimental therapy requires thousands of pregnancy tests weekly in the U.S.
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