The Ethics of Clinical Research
Authors: David G. Maggs
Journal: Annals of Internal Medicine (1999)

Letters2 February 1999The Ethics of Clinical ResearchDavid G. Maggs, MD, Gerald I. Shulman, MD, PhD, and Thomas A. Buchanan, MDDavid G. Maggs, MDYale School of Medicine; New Haven, CT 06520 (Maggs and Schulman)University of Southern California School of Medicine; Los Angeles, CA 90033 (Buchanan)Search for more papers by this author, Gerald I. Shulman, MD, PhDYale School of Medicine; New Haven, CT 06520 (Maggs and Schulman)University of Southern California School of Medicine; Los Angeles, CA 90033 (Buchanan)Search for more papers by this author, and Thomas A. Buchanan, MDYale School of Medicine; New Haven, CT 06520 (Maggs and Schulman)University of Southern California School of Medicine; Los Angeles, CA 90033 (Buchanan)Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-130-3-199902020-00014 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail IN RESPONSE: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 ...References1. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. Diabetes Control and Complications Research Group. N Engl J Med. 1993; 329:977-86. Google Scholar2. Intensive bloo d-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998; 352:837-53. Google Scholar Author, Article, and Disclosure InformationAffiliations: Yale School of Medicine; New Haven, CT 06520 (Maggs and Schulman)University of Southern California School of Medicine; Los Angeles, CA 90033 (Buchanan) PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoMetabolic Effects of Troglitazone Monotherapy in Type 2 Diabetes Mellitus David G. Maggs , Thomas A. Buchanan , Charles F. Burant , Gary Cline , Barry Gumbiner , Willa A. Hsueh , Silvio Inzucchi , David Kelley , John Nolan , Jerrold M. Olefsky , Kenneth S. Polonsky , David Silver , Thomas R. Valiquett , and Gerald I. Shulman The Ethics of Clinical Research Robert I. Misbin Metrics Cited byPlacebo-Controls in Short-Term Clinical Trials of Hypertension 2 February 1999Volume 130, Issue 3Page: 241KeywordsDrug research and developmentDrugsFood and Drug AdministrationHemoglobinHyperglycemiaInstitutional review boardsIntent to treat analysisProspective studiesResearch ethicsType 2 diabetes Issue Published: 2 February 1999 Copyright & PermissionsCopyright © 1999 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...