The FDA is pushing for pregnant women to be enrolled in clinical trials with sufficient, completed preclinical trials where the drug could provide benefits to the mother or fetus, according to the FDA's draft guidance issued April 9.
The issues discussed in the FDA's draft guidance apply to clinical trials that enroll pregnant subjects and those that allow enrolled subjects who become pregnant to stay in the trial.
The guidance also recommended pregnant women be enrolled in postmarketing trials if "adequate nonclinical studies (including studies on pregnant animals) have been completed, and there is an established safety database in nonpregnant women from clinical trials and preliminary safety data from the medical literature and/or other sources regarding use in pregnant women."
In these cases, inclusion could happen if "efficacy cannot be extrapolated and/or safety cannot be assessed by other study methods," according to the document.
The FDA said this guidance was necessary since there have been a number of barriers to obtaining data from pregnant women in clinical trials to protect them and their fetuses from research-related risks.
However, it may be helpful to collect data in pregnant women in certain situations in a clinical trial setting. "For example, it may be useful to compare the safety and efficacy of a drug that has been considered the standard of care for pregnant women with a newer treatment," the agency noted.
The document highlighted how a woman's health and the well-being of her fetus may benefit from participating in a clinical trial, adding that a pregnant woman may need access to experimental therapies in a clinical trial setting because there are no approved treatment options available. Moreover, "a drug treatment offered only through a clinical trial will hold out the prospect of direct benefit to the pregnant woman and/or her fetus beyond otherwise available therapies," the document noted.
The draft guidance also examined the issue of women who become pregnant while participating in clinical trials.
"If fetal exposure has already occurred, a woman who becomes pregnant while enrolled in a clinical trial should be allowed to continue on the investigational drug if the potential benefits of continued treatment for the woman outweigh the risks of ongoing fetal exposure to the investigational drug, of discontinuing maternal therapy, and/or of exposing the fetus to additional drugs if placed on an alternative therapy," the document reads. "Regardless of whether the woman continues in the trial, it is important to collect and report the pregnancy outcome."