Clinical Trial Enrollment and Progress in Women’s Health—Reply

In Reply: Drs Dhruva and Redberg underline the importance of sex-specific analyses in advancing women's health and agree that the value of the resulting information is worth the additional investment that may be needed to increase the enrollment of women in studies. They propose that having insurers require sex-specific analyses for approval for coverage is the “best way to guarantee that adequate sex-specific data are acquired and examined.”

The proposed requirement for approval of coverage is a useful addition to the recommendation made in the Institute of Medicine report that journals require sex-specific analyses for publication.¹ However, if the assertion that a coverage requirement is the “best way” to ensure adequately powered tests of men and women implies that a coverage requirement will be more effective than a publication requirement, I would disagree. In relation to a publication requirement, the JAMA Editor's Note accompanying my Commentary questioned whether it would occur too late in the process to be effective. Decisions regarding coverage come even later and are primarily relevant to clinical trials rather than to the full range of scientific studies providing sex-specific analyses.