FDA views children and women in trials

Ahead of the expected rise in children's enrollment in clinical trials,the US Food and Drug Administration has published a new interim rule to provide additional safeguards for pediatric inclusion in such trials, as mandated by the Children's Health Act of 2000.

The regulation provides Institutional Review Boards with specific standards for determining if proposed pediatric trials can be conducted ethically, and also sets standards and procedures for assuring that children have assented to participating in trials, when possible, and that their parents or guardians are able to give fully-informed consent to their participation.

Meantime, the agency has been told by the Women's Health Advocacy Project at Columbia University that it is not doing enough to require drug and device makers to find out if women respond to their products differently to men, reports Reuters. FDA officials replied that determining different responses to treatment due to gender and race requires large studies, which most firms have not been willing to conduct, and noted the risks for women in trials, particularly if they become pregnant while taking an experimental drug.