FDA Guidelines on the Inclusion of Pregnant Women in Clinical Trials

Pregnant Women

Earlier this month, the US FDA published a draft guidance for the inclusion of pregnant women in drug and therapeutic product development clinical trials as well as safety measures that should be taken in place to prevent potential fetal risk. The guidance discusses the scientific and ethical issues that should be considered when including pregnant women as well as consideration of the risks and benefits of the tested drug on both the woman and the fetus.

This guidance on clinical testing applies to drugs made to treat pregnancy-specific conditions, drugs for conditions that commonly occur among females of reproductive potential and also includes drugs that treat chronic disease or acute medical problems. This is needed because there are pregnant women who must use drugs that manage chronic disease or acute medical problems and much of the current information for pregnant women is based on nonclinical data or based on limited data with or without humans (i.e. testing on pregnant animals). This lack of information will leave both the pregnant woman and her health care provider reluctant to treat any present condition; in some cases, this has resulted to more harm than if she had been treated.

The FDA states that pregnant women should be involved in clinical trials that provide low to minimal risk. However, pregnant women can be enrolled in clinical trials that may involve greater than minimal risk only if the trials offer direct benefit to the pregnant woman and/or her fetus. This benefit may include access to a needed but otherwise unavailable therapy or drug that reduces the risk for acquiring a serious health condition.

The FDA recommends the inclusion of pregnant women in clinical trials in a pre-market setting can be done only if adequate nonclinical studies (studies on pregnant animals) have been completed and the trial has a possibility of a benefit to the pregnant woman and her fetus. Tests in a post-market setting can be done only if adequate nonclinical studies (studies on pregnant animals) have been completed, there is established data on clinical trials including nonpregnant women, efficacy can’t be extrapolated, or safety can’t be assessed by other methods. In all cases, the inclusion of pregnant women should be done after testing on non-pregnant women.

It should be noted that the considerations mentioned in the FDA guidance documents are not legally enforceable, they should be viewed as recommendations.

For more information, please do not hesitate to contact Focal Point Research Inc.  We are leading North American FDA and OTC Drugs consultants.