Government viewpoint of clinical trials of cardiovascular drugs.
The design of clinical trials affects their usefulness in evaluating the effectiveness and safety of drugs. Problems associated with active control studies are described and methods are given for effective dose-finding. The importance of dose-finding and dose-interval determination is emphasized.
Temple
R
R
Center for Drug Evaluation and Research, Bureau of Drugs, Food and Drug Administration, Rockville, Maryland.
D002317:Cardiovascular Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic / Q000592:standards*; D004992:Ethics, Medical; D006801:Humans; D012107:Research Design / Q000592:standards; D014481:United States; D014486:United States Food and Drug Administration
D002317:Cardiovascular Agents