title: Current issues in clinical research and the development of new pharmaceuticals.
abstract: As a normal part of the drug development process, U.S. pharmaceutical companies conduct many thousands of clinical trials each year. Only after a reasonable assurance of safety is made can the drug be given to patients who have the underlying medical condition that the drug is designed to treat. Patient welfare is assured by adhering to the Food and Drug Administration's interpretation of the "common rule" if the data will be used to support a licensing application. 21 CFR Part 50 sets forth the regulations along with the principles of informed consent and the use of institutional review boards (IRBs) that assure patients' rights are protected. Any potential conflict of interest on the part of a clinical investigator must be reported to the FDA. Pharmaceutical companies extensively monitor ongoing clinical trials for compliance with appropriate regulations. The recent revision of the Declaration of Helsinki governing placebo-controlled clinical trials may adversely impact drug development.
authors.affiliation: Pharmaceutical Research and Manufacturers of America, 1100 Fifteenth Street, NW, Washington, DC 20005, USA. agoldham@phrma.org
authors.forename: A
authors.initials: A
authors.lastname: Goldhammer
mesh_terms: D026683:Advisory Committees; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence*; D016265:Conflict of Interest; D018849:Controlled Clinical Trials as Topic; D004345:Drug Industry / Q000191:economics / Q000331:legislation & jurisprudence; D028744:Ethics Committees, Research / Q000331:legislation & jurisprudence / Q000458:organization & administration; D033161:Government Regulation; D006805:Human Experimentation / Q000331:legislation & jurisprudence / Q000592:standards; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D017387:Investigational New Drug Application; D015337:Multicenter Studies as Topic; D010919:Placebos; D012109:Research Support as Topic; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D010919:Placebos