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Pregnant women in clinical trials: FDA questions how to include them


The guidance, which recommends that clinical trial sponsors consider enlisting ethicists to take part in drug development program, offers these guidelines, among others, to drugmakers:

  • It is “ethically justifiable” to include pregnant women in clinical trials under specific circumstances. “Sponsors should consider meeting with the appropriate FDA review division early in the development phase to discuss when and how to include pregnant women in the drug development plan. These discussions should involve FDA experts in bioethics and maternal health.”
  • “Pregnant women can be enrolled in clinical trials that involve greater than minimal risk to the fetuses if the trials offer the potential for direct clinical benefit to the enrolled pregnant women and/or their fetuses.”
  • A new pregnancy during a randomized, blinded clinical trial should prompt unblinding “so that counseling may be offered based on whether the fetus has been exposed to the investigational drug, placebo, or control.”
  • The pregnant woman may continue the trial if potential benefits outweigh the risks.
  • In general, pregnant women should not be enrolled in phase 1 and phase 2 clinical trials. Instead, those trials should be completed first “in a nonpregnant population that include females of reproductive potential.”
  • Several types of events may call for the cessation of a clinical trial that includes pregnant women, such as serious maternal or fetal adverse events.

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