The Food and Drug Administration (FDA) have released guidance which provides recommendations about how and when to include pregnant women in drug development clinical trials for drugs and therapeutic biological products. The guidance aims to support 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.
The 14-page draft guidance is intended to be discussed among various entities such as the FDA, pharmaceutical manufacturers, the academic community, institutional review boards (IRBs), and any others who are involved with the conduct of clinical trials in pregnant women.
The guidance document discusses the scientific and ethical issues that should be addressed when considering the inclusion of pregnant women in drug development clinical trials. The issues explained in the guidance apply to both clinical trials that enrol pregnant subjects and to clinical trials that allow enrolled subjects who become pregnant to remain in the trial.
The majority of the information provided focuses on drugs indicated for conditions that occur commonly among females of reproductive potential, however some of the information applies to drugs indicated to treat pregnancy specific conditions, for example preterm labour and pre-eclampsia.
Further information mentioned in the draft document includes situations where it would be appropriate to stop a randomised, controlled clinical trial that is enrolling pregnant women. According to the draft, these situations include, “an appropriately planned interim analysis demonstrates superior efficacy of the control or active comparator arm” or where there are “documented serious maternal or fetal adverse events that can be reasonably attributed to drug exposure and are deemed to exceed the potential benefits of drug treatment.”
To view the FDA’s draft guidance on the scientific and ethical considerations for including pregnant women in clinical trials, please click here.