Factors Influencing Post‐Menopausal African‐American Women’s Participation in a Clinical Trial

The Office on Women’s Health Research was established within the Office of the Director, National Institutes of Health (NIH) in 1990 with a mandate to strengthen and enhance prevention, diagnosis, and treatment of illness in women and to enhance research related to diseases and conditions that affect women. The NIH Office for Women’s Health Research summary of public testimony targeted the following areas as high priority for research: cancer prevention (especially breast cancer) cardiovascular disease, osteoporosis, autoimmune diseases, sexually transmitted diseases, work site safety, domestic violence, postnatal care, AIDS, and consequences of women’s hormonal cycles for pharmacotherapy (Barry, Gooding, Harris, Hazzard, 8c Winograd, 1993). The diversity of women’s health needs was stressed, considering special populations, African-American, Hispanic, and poor women (Grisso & Watkins, 1992). In keeping with the priorities of the NIH Office for Women’s Health Research, the authors implemented an observational study to identify risk factors in AfricanAmerican post-menopausal women and to further identify women who would be eligible for a clinical trial examining the effects of alendronate on bone density. (The geminal biphosphonates are specific inhibitors of bone resorption, potentially useful in osteoporosis.) This report describes efforts undertaken to recruit subjects from the community of African-American women for an observational study and a subsequent clinical trial. The observational study was designed to identify health risk factors in this group about which very little is known, and to screen subjects for eligibility for the clinical trial. According to the National Institute on Aging (NIA), half of all people older than 75 suffer from osteoporosis, a major cause of fractures in the spine, hip, wrist, and other bones. Twenty-five percent of women older than 60 have osteoporosis (Barry et al., 1993). The prevalence of osteoporosis in African-American women is not known, but is expected to be a great deal lower than in whites. Clinicians report that African-American women who do experience a fracture of the femur have a much longer recovery time and a higher rate of mortality than whites (Bocanegra, personal communication, January 13, 1994). Women’s health has been the missing chapter in America’s focus on medical research. Heart disease, cancer, and osteoporosis are the three main causes of morbidity and mortality in older women. While a major focus has been launched in these areas during the last 3 years, few efforts have been directed specifically at older African-American women (Cotton, 1992). In the past 5 years, the NIH has launched major campaigns and guidelines to encourage the recruitment of minorities and women in clinical trials. Critical to the success of any clinical trial is the recruitment of adequate sample sizes of eligible subjects and the prevention of subject attrition once the trial begins (Bennett, 1993). The purpose of this substudy was to determine which factors most influence post-menopausal African-American women’s participation in a multisite clinical trial. Research questions for the substudy were: Which recruitment methods work best with African-American women? 0 Which methods prevent attrition and adherence to the study protocol? 0 What special strategies need to be considered in recruiting and implementing a clinical trial for this population of women?