FDA Released Draft Guidance for Pregnant Women in Clinical Trials

by GeneOnline
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Pregnant women will be able to participate in certain clinical trials in the near future, suggested by the Food and Drug Administration (FDA) in a draft guidance for drug development clinical trial.

By Joanne Shih

The lack of scientific bases and clinical evidences for the use of many drugs, vaccines, and therapeutic biological products in pregnant women has been a long medical concerns. FDA pointed the current challenges in drug development research in pregnant women, “Like women who are not pregnant, some pregnant women need to use drugs to manage chronic disease conditions or treat acute medical problems. To the extent there is labeling information for pregnant women, it is usually based on nonclinical data with or without limited human safety data. The frequent lack of information based on clinical data often leaves the health care provider (HCP) and the patient reluctant to treat the underlying condition, which in some cases may result in more harm to the woman and the fetus than if she had been treated.”

When pregnant women participate in clinical trials, concern of risks or negative impacts which may impose on both mother and fetus remains. To address research-related risks, FDA outlines certain conditions for clinical trials to ensure both maternal and fetal safety and to minimize potential risks related to clinical trials. Considerations include the type and severity of diseases, availability of treatment options for pregnant women, and stages of drug development. Adequate nonclinical studies (including studies on pregnant animals) must have been completed before considering trials in pregnant women. Different criteria need to be met depending on the stages of drug development. For example, drugs in the post-marketing setting such as FDA-approved drugs can recruit pregnant women to participate in clinical trials if safety database in nonpregnant women from clinical trials or preliminary safety data from the medical literature is established and safety in pregnancy condition cannot be assessed by other study methods. On the other hand, clinical trials in the pre-marketing setting need to demonstrate a prospect of direct benefit to pregnant women and/or fetuses that cannot be obtained from outside a research setting or by any other methods.

Yet the draft guidance is released for comments and public opinions at this stage, and will be reviewed in more details before official implementation. FDA also stated in the document that the guidance does not establish legal enforcement and should be view as recommendation unless specific conditions are cited.

Comments and suggestions regarding this draft guidance may be submitted by June 8, 2018, via the Federal Register.


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