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CTTI Article Outlines Recommendations for Pregnancy Testing in Clinical Trials

Most 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 for female trial participants of reproductive potential, nor how risks should be clearly communicated with them.

In a recent article in PLOS ONE, CTTI shares recommendations developed by experts in academia, industry, and regulatory agencies on pregnancy testing in clinical research. They include the following:

  • The study protocol should clearly state the rationale for pregnancy testing and the plan for handling positive and indeterminate tests.
  • Investigators should assess the balance of the advantages and burdens of the pregnancy testing plan, as well as and evaluate participant burdens regarding the likelihood of false negative and false positive results.
  • Participant-administered home pregnancy testing should be avoided in clinical trials.
  • The consent process should describe what is known about the study intervention’s potential risk to an embryo or fetus and the limitations and consequences of pregnancy testing.

CTTI also developed an online tool to estimate the potential outcomes of different pregnancy testing strategies in the proposed trial population. Together, these resources aim to help research sponsors, investigators, and institutional review boards create and review pregnancy testing plans, in an effort to conduct safer, more efficient clinical trials.