Impediments to clinical research in the United States.
Clinical trials are essential to the evaluation of promising scientific discoveries, but they are becoming unsustainably burdensome, threatening to deprive patients and health-care providers of new therapies and new evidence to guide the use of existing treatments. Regulations are often blamed for impeding clinical research, but there are other elements of the clinical trials enterprise that also have the potential to add burdens, through either imposed requirements or incentives that do not favor clinical research (Figure 1).
Department of Medicine, Duke University Medical Center, Durham, North Carolina, USA. judith.kramer@duke.edu
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D016907:Adverse Drug Reaction Reporting Systems; D035843:Biomedical Research / Q000331:legislation & jurisprudence*; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D028744:Ethics Committees, Research / Q000331:legislation & jurisprudence*; D006805:Human Experimentation / Q000331:legislation & jurisprudence*; D006801:Humans; D014481:United States