Medical research should include more women participants and examine the role of gender in disease

Despite the growing literature on the clinical importance of gender, the Australian team noted that the majority of the 400 studies reviewed did not analyze the potential role of participant’s gender in their published research. Drs. Rogers and Ballantyne recommend that clinical trials registries collect data on the gender of participants “to facilitate further research in this area and that researchers, journal editors, and peer reviewers work to standardize mechanisms for sex-specific reporting and analysis in publications.”

In a companion editorial, cardiologists Sharonne N. Hayes, M.D., director of the Mayo Clinic Women’s Heart Clinic, and Rita Redberg, M.D., from the University of California, San Francisco, explore the historical context surrounding the limited role of women participating in medical research and provide additional data that echo the findings of the Australian team.

“We observed the same phenomenon in a recent review of cardiology clinical trials where only 25 percent of all studies reported results by sex. As heart disease is the leading cause of death in women, it is dismaying that data from cardiovascular clinical trials are so limited,” write Drs. Hayes and Redberg.

Noting that unexpected gender-based differences have been found in many diseases, including lung cancer, degenerative joint disease, depression and other mental health disorders, Drs. Hayes and Redberg assert that “the lack of sex differences should not be assumed and instead must be systematically studied.” Given this information, “analyzing data by sex for conditions or treatments affecting both men and women is the only way we will be able to begin to provide optimal care for all patients,” they write.

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