Regulatory Issues in Prostate Cancer Studies.
Quality of life and informed consent are two of the important issues for designers of clinical trials. The former has physical, psychological, economic, and social components. Investigators must understand the features of the various measurement instruments and select one that is appropriate to the circumstances. It also is necessary to identify what changes are significant. Statistical significance is not identical to clinical significance. Ethical guidelines for the protection of human subjects is another important issue. Information on regulations is available on many Web sites, including that of the Food and Drug Administration.
Fourcroy
JL
Office of Health Affairs, Food and Drug Administration, Bethesda, Maryland.