October 6, 2015— Women are underrepresented in clinical trials for HIV drugs and related research, according to a study published in the Journal of Acquired Immune Deficiency Syndromes, Reuters reports.
For the study, researchers analyzed 500 studies published in major medical journals. The studies were published over several decades, including studies as recent as 2012.
The researchers found that while women comprised about 50% of HIV cases worldwide, they usually accounted for only 11% of study participants in studies examining HIV cures, 19% of study participants in studies for HIV drugs and 38% of study participants in studies for HIV vaccines.
Lead author Mirjam Curno and colleagues noted that, historically, female participation also has been low in cancer, depression and heart disease research as well as in advanced human trials for experimental drugs. Curno said, "Based on previous studies in other health areas, [their study finding] wasn't surprising, but perhaps disappointing given that nearly half of those living with HIV are women."
Senior study author Shirin Heidari said, "Failing to systematically study sex and gender differences in health research leads to less evidence-based medicine for one sex or another." Heidari noted that women and men can have different symptoms and respond differently to the same treatment, even when the disease is the same.
Mary Foulkes -- a biostatistics researcher at George Washington University, who was not involved in the study -- noted that the studies might not have intended to favor men but enrolled fewer women because of constraints that disproportionately affect women, such as need for child or elder care and limited time or transportation. She added that the study did not examine why women who might have been eligible for an HIV study opted not to participate.
Further, Foulkes noted that trial enrollment criteria that prevent women who are pregnant, nursing or of childbearing age from signing up can limit the study from enrolling enough women, Reuters reports. In addition, Monica Gandhi -- an HIV specialist at the University of California-San Francisco, who also was not involved in the study -- said eligibility criteria have prevented large numbers of women from participating even in HIV trials intended for female patients. Gandhi added that the underrepresentation of women in HIV studies can limit the value of any study findings for female HIV patients (Rapaport, Reuters, 10/2).