The National Institutes of Health today announced the selection of 16 "Vanguard Clinical Centers" for Women's Health Initiative, a massive national research effort to learn more about women's health.
The work of the 16 university medical programs selected will be a part of NIH's Women's Health Initiative - planned as a 15 year, $625 million study, the largest clinical trial ever undertaken in the United States.
The work of this project is overdue," said HHS Secretary Donna E. Shalala. "This Initiative is a first step toward equity for women's health research, and it needs to be followed-up by ensuring the place of women's health in the mainstream of biomedical research.
The Vanguard Clinical Centers will link sites in 15 states to implement the Women's Health Initiative, which will involve more than 160,000 women ages 50 to 79.
NIH Director Bernadine Healy, M.D., said, "Today, we are entering a new age in women's health research. In terms of medical research, women have been ignored too long. These Vanguard Clinical Centers will play a pivotal role in NIH's commitment to include women in medical research and gather vital data to help prevent the major problems that afflict older women."
The study will focus on the causes and prevention of heart disease, cancer and osteoporosis, diseases that are major causes of death and disability among women. It will examine, through clinical trials or observational studies, the effects of a low-fat diet in preventing breast and colorectal cancer and heart disease; the benefits and the risks of hormone-replacement therapy in preventing cardiovascular disease and osteoporotic fractures; and the effects of calcium and vitamin D supplements in preventing osteoporotic fractures and colorectal cancer.
Researchers expect that results from the Women's Health Initiative will provide scientifically valid information for women and their physicians in hopes of improving overall health and promoting longer life.
The initial 16 Vanguard Clinical Centers will test, refine and implement the final study design and operating procedures to enroll women nationwide in the first stage of clinical trials by September 1993). By mid-1994, an additional 29 clinical centers will be added -- constituting an unprecedented alliance of 45 medical schools, hospitals and non-profit institutions committed to uncovering vital information to improve the quality of life for women. The average contract award per Vanguard Clinical Center amounts to nearly $10.5 million over a 15-year period.
Each of the 45 Vanguard Clinical Centers will recruit 3,490 women over three years for the clinical trial and observational study. The broad geographic distribution of the Vanguard Clinical Centers allows for recruitment efforts in medically underserved areas and targets minority populations across the country, in order to obtain a representative cross-section of the United States population. Four of the 16 centers chosen will primarily recruit minority participants. These four centers are:
"We will be vigilant in our efforts to ensure that the results of the Women's Health Initiative have meaning to all women from all socio-economic and racial backgrounds," said Dr. William Harlan, co-director of the Women's Health Initiative and associate director of the Office of Disease Prevention at NIH.
Principal investigators from each Vanguard Center will hold their first meeting in Seattle, Wash., on March 31. They will review the study design, and establish committee assignments in preparation for their second meeting on April 20-21 in Bethesda, Md.
Dr. Healy said, "The Women's Health Initiative is NIH's commitment to redress the crucial medical knowledge gaps women continue to face today. Launching this national program will permanently put women's health concerns on the nation's research agenda.
NIH is the largest of eight U.S. Public Health Service agencies in HHS. Each of the eight agencies is emphasizing women's health research or services.
The 16 VANGUARD CENTERS ANNOUNCED TODAY: