The FDA has published new guidelines that should ensure thatwomen -- especially women of child-bearing age -- as well asmen are included in the volunteer cohorts and patientpopulations of clinical trial protocols.

FDA's proposed guidelines, published Thursday in The FederalRegister and discussed in Thursday's issue of The New EnglandJournal of Medicine, call for better assessment of possiblegender differences in response to new medications.

The new guidelines encourage companies to include patients ofboth genders in drug development, and to analyze theeffectiveness and safety data bases to look for significantdifferences in response to experimental drugs between menand women.

The FDA has also eliminated its 1977 restriction onparticipation of women of child-bearing potential in earlyclinical studies. The policy stresses that institutional reviewboards, clinical investigators and patients should play a greaterrole in determining whether participation of women in trials isappropriate and how best to ensure that there is no exposureof a fetus to potentially toxic agents.

The FDA believes that the new policy will permit earlierdetection of gender differences that could lead to betterselection of doses and monitoring procedures in later studies.The gender-specific data will also result in better labelinginformation for prescribing physicians, the agency said.

"The new guideline reflects good drug development practiceimplicit in the law and regulations," FDA said. As for companiesthat may have already designed clinical trial protocols, "...where (drug) sponsors have developed drugs in good faithrelying on existing guidelines, they will have an opportunity tosatisfy newly appreciated data needs after approval where thisis compatible with the public health and the law," theguidelines state.

Comments on the guidelines may be submitted by Nov. 19 to:Dockets Management Branch, HFA-305, Room 1-23, 12420Parklawn Drive, Rockville, MD 202857.

-- Jennifer Van Brunt Senior Editor

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