(Last in a three-part series)
Although women’s health advocates have the muscle of a federal law behind their efforts to include women in clinical studies, barriers still abound that prevent women from participating in this vital research.
The most recent evidence comes from a study published in the June issue of the Journal of Women’s Health and Gender-Based Medicine. The study examined 865 articles in four leading peer-reviewed medical journals and found that 21 percent of the studies failed to include women, despite federal regulations requiring researchers to do so.
Excluding women from clinical trials has limited scientific knowledge of the differences in how diseases and treatments affect women and men. Yet the leading advocate for including women in medical research says that part of the problems is that women often do not volunteer for clinical trials due to logistical, cultural or financial reasons.
The Society for Women’s Health Research, a Washington, D.C.-based advocacy group, points out that participating in a trial often means extra visits to a doctor or clinic for examinations or laboratory tests. Thus, joining a clinical trial becomes unrealistic for women who have no transportation or no one to care for their children during their absence.
Financial resources also may come into play. Often, investigators do not pay for laboratory work, medications and other expenses incurred by study participants.
Some women also mistrust the medical establishment. The thalidomide and Tuskegee studies–both infamous experiments that resulted in horrific birth defects, in the first case, and African-American men with syphilis left untreated in the second–undermined the research community’s credibility.
Another problem: studies have often been designed and conducted by men, who don’t necessarily think about recruiting and retaining women participants.
Eliminating these barriers is no small task, however. As Cynthia Pearson, executive director of the National Women’s Health Network, an advocacy group based in Washington, D.C., puts it:
“There’s no one thing that’s going to be a quick fix. There are so many nuances to eliminating the barriers. You’re not just talking about taking down a sign that says ‘Men only’,” she said, adding longstanding attitudes and practices among researchers cannot be changed quickly.
A few researchers have already found ways to make clinical trials more workable for women participants, Pearson said. In a Los Angeles study, technicians drew blood when it was convenient for participants–at 7:30 a.m. or 9 p.m. Another option would be for clinics to extend their hours or offer at-home services, she added.
But funding agencies, such as the National Institutes of Health, also need to do more, Pearson argued. These agencies should offer incentives or “bonus points” for research proposals that include proven solutions for overcoming the barriers to including women.
“We still believe there needs to be incentives and continued scrutiny and it has to come from up and down the spectrum–from Congress, from each Public Health Service agency and from outside groups that are concerned about a condition or women’s health overall,” Pearson said. The Society for Women’s Health Research also is urging the National Institutes of Health to revise grant application forms to require researchers to address how they plan to include women and whether they can analyze results by gender. Currently, no requirement is explicitly stated on the application.
The Society for Women’s Health Research suggestions for improving participation by women are that medical researchers should:
- Provide financial coverage for participants in the study, including reimbursement for transportation and child care. They should also ensure ancillary care and other expenses associated with participation are covered by participants’ health insurance.
- Include the participant’s own health care provider in the study, to instill trust in the participant. They should also inform participants of the study’s protocol, treatment and implications.
- Include women staff in clinical trial , particularly women with the same ethnic or racial background as the targeted population. They should use women as investigators and educators to attract more women and foster more trust among female participants.
- Involve women and minorities in the design of the research, preparing the study materials and interacting with participants in a culturally and linguistically sensitive manner.
Pearson acknowledged that progress has been made in including women in clinical trials.
“We’re more optimistic than pessimistic. We’re on the right road, but we just have to move further down the road.”
Melinda Voss has a master’s degree in public health. She is a former long-time reporter for The Des Moines Register. She now freelances and teaches journalism at the University of Minnesota.