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Patient-Important Outcomes in Registered Diabetes Trials

Patient-Important Outcomes in Registered Diabetes Trials ORIGINAL CONTRIBUTION Patient-Important Outcomes in Registered Diabetes Trials Gunjan Y. Gandhi, MD, MSc Context Concerns about the safety and efficacy of diabetes interventions persist, in part because randomized clinical trials (RCTs) have not measured their effect on patient- M. Hassan Murad, MD, MPH important outcomes, ie, death and quality of life (morbidity, pain, function). Akira Fujiyoshi, MD, MPH Objective To systematically determine the extent to which ongoing and future RCTs Rebecca J. Mullan, MS in diabetes will ascertain patient-important outcomes. David N. Flynn, BS Data Sources On November 10, 2007, we searched primary RCT registries Mohamed B. Elamin, MBBS ClinicalTrials.gov (http://www.clinicaltrials.gov), International Standard Randomized Controlled Trial Number Register (http://isrctn.org), and Australian New Zealand Clini- Brian A. Swiglo, MD cal Trials Registry (http://www.anzctr.org.au). William L. Isley, MD† Study Selection We identified phase 2 through 4 RCTs enrolling patients with dia- Gordon H. Guyatt, MD, MSc betes. Of 2019 RCTs, 1054 proved eligible. We randomly sampled 50% of the eli- gible RCTs (527 of 1054) and selected 436 registered since registration became man- Victor M. Montori, MD, MSc datory (2004). RIALS MEASURING BIOCHEMICAL Data Extraction Pairs of reviewers working independently collected study charac- and surrogate markers may help teristics and determined http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

Patient-Important Outcomes in Registered Diabetes Trials

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References (34)

Publisher
American Medical Association
Copyright
Copyright 2008 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.299.21.2543
pmid
18523223
Publisher site
See Article on Publisher Site

Abstract

ORIGINAL CONTRIBUTION Patient-Important Outcomes in Registered Diabetes Trials Gunjan Y. Gandhi, MD, MSc Context Concerns about the safety and efficacy of diabetes interventions persist, in part because randomized clinical trials (RCTs) have not measured their effect on patient- M. Hassan Murad, MD, MPH important outcomes, ie, death and quality of life (morbidity, pain, function). Akira Fujiyoshi, MD, MPH Objective To systematically determine the extent to which ongoing and future RCTs Rebecca J. Mullan, MS in diabetes will ascertain patient-important outcomes. David N. Flynn, BS Data Sources On November 10, 2007, we searched primary RCT registries Mohamed B. Elamin, MBBS ClinicalTrials.gov (http://www.clinicaltrials.gov), International Standard Randomized Controlled Trial Number Register (http://isrctn.org), and Australian New Zealand Clini- Brian A. Swiglo, MD cal Trials Registry (http://www.anzctr.org.au). William L. Isley, MD† Study Selection We identified phase 2 through 4 RCTs enrolling patients with dia- Gordon H. Guyatt, MD, MSc betes. Of 2019 RCTs, 1054 proved eligible. We randomly sampled 50% of the eli- gible RCTs (527 of 1054) and selected 436 registered since registration became man- Victor M. Montori, MD, MSc datory (2004). RIALS MEASURING BIOCHEMICAL Data Extraction Pairs of reviewers working independently collected study charac- and surrogate markers may help teristics and determined

Journal

JAMA – American Medical Association

Published: Jun 4, 2008

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