Document Detail


Viewpoint: professional integrity in industry-sponsored clinical trials.
MedLine Citation:
PMID:  16186605     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Evidence-based medicine (EBM) relies on accurate data derived from well-designed, clinically relevant randomized controlled trials (RCTs). Most randomized trials, however, are conducted by industry sponsors aiming at licensing and marketing drugs, which may weaken the usefulness of the findings to EBM. Disturbing evidence has emerged of widespread biases in industry-sponsored trials, including publication bias, selective reporting of findings, and distorted interpretation of results. These practices compromise the professional integrity of physician-investigators who contribute to them. In turn, the well-being of patients participating in RCTs may be jeopardized, and the evidence base upon which EBM is practiced may be corrupted. Regulatory reform alone will be inadequate to resolve these problems; attention must also be paid to physicians' professionalism. The authors recommend a change in the culture of academic medicine whereby physician-investigators who maintain professional integrity are rewarded or recognized. Educational interventions promoting integrity in clinical research may be one part of affecting such change.
Authors:
Franklin G Miller; Howard Brody
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Academic medicine : journal of the Association of American Medical Colleges     Volume:  80     ISSN:  1040-2446     ISO Abbreviation:  Acad Med     Publication Date:  2005 Oct 
Date Detail:
Created Date:  2005-09-27     Completed Date:  2005-12-13     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8904605     Medline TA:  Acad Med     Country:  United States    
Other Details:
Languages:  eng     Pagination:  899-904     Citation Subset:  AIM; E; IM    
Affiliation:
Unit on Clinical Research, Department of Clinical Bioethics, National Institutes of Health, Building 10, Room 1C118, Bethesda, Maryland 20892, USA. fmiller@nih.gov
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MeSH Terms
Descriptor/Qualifier:
Advertising as Topic
Biomedical Research
Clinical Trials as Topic*
Evidence-Based Medicine
Health Care Sector*
Humans
Physician's Role
Professional Competence*
Publication Bias

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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