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June 18, 1997

Clinical Trial Investigators Talk About Getting the Data

JAMA. 1997;277(23):1833-1836. doi:10.1001/jama.1997.03540470015007

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WHAT ARE the challenges and the problems involved in conducting clinical trials? To add perspective to the other reports in this section, MEDICAL NEWS asked 3 investigators who are experienced in running, managing, and reviewing clinical trials for their opinion. Darrell Abernethy, MD, is director of the Clinical Research Center at Georgetown University School of Medicine, Washington, DC; William R. Harlan, MD, is associate director for disease prevention at the National Institutes of Health (NIH) in Bethesda, Md; and Robert Temple, MD, is director of the Office of Drug Evaluation 1, Center for Drug Evaluation and Research, at the US Food and Drug Administration, Rockville, Md.

JAMA:  When did clinical trials begin? How have they changed over the years? Have investigators become smarter about the number of subjects needed to ensure statistical significance, for example?

Dr Harlan:  Clinical trials as we know them today may not have started until after