Stakeholders Urge Tweaks in Draft Guidance on Pregnant Trial Subjects

The FDA’s draft guidance on inclusion of pregnant women in clinical trials needs some fine tuning, according to stakeholders, including more clarity on non-adherence to therapies.

The agency issued the draft guidance in April and said it considers the inclusion of such subjects ethically justifiable if adequate nonclinical studies have been completed and if the trial could deliver benefits to the women and/or the fetus that otherwise cannot be obtained.

In a written comment, Biocon called on the agency to add a section on non-adherence to injectable therapies, noting that fear of needles is common in pregnant women and urging the agency to allow pregnant women to be enrolled in a trial using an alternative formulation administered through other routes, such as orally or nasally.