September 24, 2010
Researchers need to find ways to make clinical trials more inclusive of women, according to Judith Feinberg, an infectious-disease expert at the University of Cincinnati. Jobs, child care, and transportation often affect whether women complete clinical trials, which can last for a year or longer and require multiple doctor visits, Feinberg said.
Feinberg headed up the local arm of the national Gender, Race and Clinical Experience (GRACE) trial, which enrolled 287 women and 142 men at 65 centers in the United States, Canada, and Puerto Rico. The Phase IIIb clinical trial was designed to assess how well women and minorities who had failed on other HIV drugs responded to Prezista.
Women are the fastest-growing group to be newly diagnosed with HIV, so it is key that scientists learn what drugs are most effective for them. New infection rates are highest among African-American women. "The reality is we prescribe drugs to women all the time that have only or primarily been tested on men," said Feinberg.
Of the study's female participants, 84 percent were African-American or Hispanic. While the researchers were able to recruit the right number of women and the correct demographic mix, retaining females during the trial proved difficult.
Almost one-third of women dropped out of the 48-week study for reasons unrelated to Prezista's side effects, compared to just one-fourth of men. The drug was equally effective in men and women, but failure rates were higher in black women because they left the trial early and thus had to be counted as treatment failures, said Feinberg.
The study's authors concluded: "Nonsignificant, sex-based differences in responses were found during the 48-week study; however, these differences were probably due to higher discontinuation rates in women, suggesting that additional efforts are needed to retain women in clinical trials."
The study, "Sex-Based Outcomes of Darunavir-Ritonavir Therapy: A Single-Group Trial," was published in the Annals of Internal Medicine (2010;153(6):349-357).