FDA Guidance on Including Pregnant Women in Clinical Trials

PUBLISHED: Apr 10, 2018
Relevant to: Critical Access Hospitals, Hospitals

The U.S. Food and Drug Administration (FDA) has issued guidance on including pregnant women in clinical trials. This guidance provides recommendations about how and when to include pregnant women in drug development clinical trials for drugs and therapeutic biological products based on the FDA’s current thinking on this subject.

Specifically, this guidance supports an informed and balanced approach to gathering data on the use of drugs and biological products during pregnancy through judicious inclusion of pregnant women in clinical trials and careful attention to potential fetal risk. This draft guidance is intended to serve as a focus for continued discussions among various entities such as the FDA, pharmaceutical manufacturers, the academic community, institutional review boards (IRBs), and others who are involved with the conduct of clinical trials in pregnant women.

According to the FDA, there are multiple reasons for considering the inclusion of pregnant women in clinical trials, including the following:

  • Women need safe and effective treatment during pregnancy.
  • Failure to establish the dose/dosing regimen, safety, and efficacy of treatments during pregnancy may compromise the health of women and their fetuses.
  • In some settings, enrollment of pregnant women in clinical trials may offer the possibility of direct benefit to the woman and/or fetus that is unavailable outside the research setting.
  • Development of accessible treatment options for the pregnant population is a significant public health issue.

There are several ethical and safety considerations that must be considered before, during and after including pregnant women in clinical trials. This draft guidance reviews:

  • Ethical considerations.
  • FDA regulations that govern research in pregnant women.
  • General guidelines for including pregnant women in clinical trials.
  • Other considerations like the timing of enrollment, safety data collection and stopping a clinical trial.

Follow the link below to review this new FDA guidance. Included with today’s notice is an example policy related to the inclusion of pregnant women in clinical trials.

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