race, and sex. In 2000, FDA issued the clinical-hold rule, which permits FDA to stop IND studies of treatments for life-threatening diseases if women are excluded because of their reproductive potential.
Parekh noted that data reported in poster sessions at a recent Drug Information Association meeting indicated that analysis of safety and efficacy data by sex has been increasing—around 75% of clinical trials in 2007–2009 reported analysis by sex—and a review of approved product labels found that nearly all included pharmacokinetic information by sex.
With regard to reporting in the literature, Nolan said that a decade ago the NIH ORWH, in collaboration with SWHR, convened a meeting of scientific-journal editors to discuss the development of specific instructions for authors and reviewers about the analysis of clinical-trial data by sex. However, in an informal survey of 11 science journals2 conducted by SWHR in 2010, only JNCI and Circulation required reporting of sex differences; the others did not set any sex-specific requirements for authors.
Nolan cited several recent articles that draw attention to the need to consider sex differences. In March of 2010, an article in Science reported on sex bias in animal models and predicted that reporting would change if journals adopted a common set of guidelines for manuscripts to provide details on the sex of the animals used and required authors to state their rationale for studying only one sex and the implications of not studying the other (Wald and Wu, 2010). A June 2010 editorial in Nature suggested that funding agencies should require researchers to justify sex inequalities in grant proposals and should favor proposals that include both sexes; that FDA should ensure that physicians and the public are aware of sex differences in drug reactions and dosages; and that medical schools should train physicians in how diseases, symptoms, and drug responses can differ by sex (Putting gender on the agenda, 2010). The editorial also noted that Nature was considering whether to require authors to document the sex of animals in published papers. Finally, an article in the New England Journal of Medicine in June 2010 noted how the global H1N1 influenza pandemic disproportionately affected pregnant women and stressed the need for inclusion of pregnant women in clinical trials (Goldkind et al., 2010).
2Journal of the National Cancer Institute (JNCI), Circulation, JAMA, New England Journal of Medicine, Endocrinology, American Journal of Physical Medicine & Rehabilitation, BMJ, Lancet, Immunology, Gastroenterology, and Urology.