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Office of Minority Health Public Health Service U.S. Department of Health and Human Services

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In This Issue: Clinical Trials, How They Work, Why We Need Them Minority Participation in Clinical Trials Searching for AIDS Vaccine Women's Health Initiative Cancer Prevention Program NIH Clinical Center Blacks in Cancer Trials Ethics of HIV Trials in Africa MEDTEP Research on Minority Populations Diabetes Prevention Obesity Women and Minorities in Clinical Trials Kidney Research Discovering Kidney Cancer Genes Fears of Genetic Testing Support for Women's Health Resources Conference Calendar

Clinical Trials How They Work, Why We Need Them e’ve all taken medication. It may have been in the form of over-the-counter cough medicine, or prescription pills to treat chronic conditions such as diabetes. But how did researchers discover if the medicine is effective, if it’s safe, and if there are any potential side effects? Testing and evaluating drugs is serious business, and clinical trials are right at the center of the process, according to Dorothy Cirelli, chief of the Patient Recruitment and Referral Center at the National Institutes of Health (NIH), U.S. Department of Health and Human Services (HHS). “Medical advances would not occur without clinical trials,” she said. Well known as a world leader in medical research, NIH developed the first treatment for the human immunodeficiency virus (HIV), as well as innovative therapies for breast cancer, leukemia and lymphoma. For over a century, the agency has conducted clinical studies that explore the nature of illnesses. Clinical studies are currently underway for nearly every kind of cancer, HIV, cardiovascular disease, diabetes, obesity, and many other conditions—common and rare. There are several types of clinical trials. By far the largest number are those that test new drugs. Prevention studies look at drugs or lifestyle changes that may help prevent disease. Diagnostic studies look at ways of detecting or finding out more about disease. Treatment studies may monitor new drugs or evaluate new combinations of established treatments. The Food and Drug Administration (FDA), another HHS agency, is responsible for reviewing the scientific work of drug developers and implementing a rigorous drug approval process. FDA, which some have called the world’s largest consumer protection agency, works to protect the public by ensuring that products are safe, effective, and labeled for their intended use. continued next page

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