Requirements for researchers to enroll women in clinical trials have enabled many advances. Yet the full benefit of increased participation by women has not been realized because researchers do not routinely analyze and report results separately for women and men, the committee observed. This limits the breadth and depth of clinical information that could facilitate more effective interventions and treatments for women. Journal editors should adopt a guideline that all papers reporting outcomes of clinical trials must present data on men and women separately unless a trial focuses on a sex-specific condition such as prostate cancer, the report says. In addition, the U.S. Food and Drug Administration should enforce companies' compliance with requirements to provide sex-specific data on the efficacy and safety of new drugs and devices and should take this information into account when it considers approval, dosing, and labeling of products.

Although the dramatic increase in women's health research has generated an abundance of new information of interest to women, the course of scientific study sometimes yields conflicting findings and opposing recommendations that can cause confusion among the public. The committee recommended that the U.S. Department of Health and Human Services appoint a task force to develop strategies to communicate and market health messages about research results to women. The task force should include experts on mass media and marketing.

The sheer number of health conditions relevant to women and volume of information available on many of them precluded analysis of all conditions in the report. Lack of discussion should not suggest that the committee considered a specific condition unimportant. By necessity, the committee focused on those that are specific to or more common or serious in women or that have distinct causes, manifestations, outcomes, or treatments in women. And it selected conditions that could provide broadly applicable conclusions.

The report was sponsored by the U.S. Department of Health and Human Services. Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public. The National Academy of Sciences, National Academy of Engineering, Institute of Medicine, and National Research Council make up the National Academies.

Source: National Academy of Sciences