David G. Maggs, MD; Gerald I. Shulman, MD, PhD; Thomas A. Buchanan, MD
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Maggs D., Shulman G., Buchanan T.; The Ethics of Clinical Research. Ann Intern Med. 1999;130:241. doi: 10.7326/0003-4819-130-3-199902020-00014
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Published: Ann Intern Med. 1999;130(3):241.
Until recently, the Food and Drug Administration criteria for new drugs in development to treat type 2 diabetes required at least one placebo-controlled, proof-of-efficacy study for regulatory acceptance and review. Our study was initiated in 1994 in patients participating in a proof-of-efficacy study authorized by the Food and Drug Administration and approved by 24 independent ethics and institutional review boards. We now have a deeper understanding of the harmful effects of hyperglycemia, as indicated by the Diabetes Control and Complications Trial (1) and in the immediate wake of the recent United Kingdom Prospective Diabetes Study (2). With this increased understanding, the ethics of placebo-controlled study designs can be challenged.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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