Viewpoint: professional integrity in industry-sponsored clinical trials. 2005

Franklin G Miller, and Howard Brody
Unit on Clinical Research, Department of Clinical Bioethics, National Institutes of Health, Building 10, Room 1C118, Bethesda, Maryland 20892, USA. fmiller@nih.gov

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.

UI MeSH Term Description Entries
D010819 Physician's Role The expected function of a member of the medical profession. Physicians' Role,Physician Role,Physician's Roles,Physicians Role,Physicians' Roles,Role, Physician's,Role, Physicians',Roles, Physician's,Roles, Physicians'
D011361 Professional Competence The capability to perform the duties of one's profession generally, or to perform a particular professional task, with skill of an acceptable quality. Competence, Professional,Generalization of Expertise,Technical Expertise,Expertise Generalization,Expertise, Technical
D002986 Clinical Trials as Topic Works about pre-planned studies of the safety, efficacy, or optimum dosage schedule (if appropriate) of one or more diagnostic, therapeutic, or prophylactic drugs, devices, or techniques selected according to predetermined criteria of eligibility and observed for predefined evidence of favorable and unfavorable effects. This concept includes clinical trials conducted both in the U.S. and in other countries. Clinical Trial as Topic
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000329 Advertising Works about the act or practice of calling public attention to a product, service, need, etc., especially by paid announcements in newspapers, magazines, on radio, or on television. (Random House Unabridged Dictionary, 2d ed) Advertising as Topic,Advertisement as Topic,Telemarketing,Advertisings
D017594 Publication Bias The influence of study results on the chances of publication and the tendency of investigators, reviewers, and editors to submit or accept manuscripts for publication based on the direction or strength of the study findings. Publication bias has an impact on the interpretation of clinical trials and meta-analyses. Bias can be minimized by insistence by editors on high-quality research, thorough literature reviews, acknowledgement of conflicts of interest, modification of peer review practices, etc. Bias, Publication
D019317 Evidence-Based Medicine An approach of practicing medicine with the goal to improve and evaluate patient care. It requires the judicious integration of best research evidence with the patient's values to make decisions about medical care. This method is to help physicians make proper diagnosis, devise best testing plan, choose best treatment and methods of disease prevention, as well as develop guidelines for large groups of patients with the same disease. (from JAMA 296 (9), 2006) Medicine, Evidence-Based,Evidence Based Medicine,Medicine, Evidence Based
D019981 Health Care Sector Economic sector concerned with the provision, distribution, and consumption of health care services and related products. Health Care Market,Healthcare Industry,Health Care Industry,Healthcare Market,Healthcare Sector,Industry, Healthcare,Health Care Industries,Health Care Markets,Health Care Sectors,Healthcare Industries,Healthcare Markets,Healthcare Sectors,Industries, Health Care,Industries, Healthcare,Industry, Health Care,Market, Health Care,Market, Healthcare,Markets, Health Care,Markets, Healthcare,Sector, Health Care,Sector, Healthcare,Sectors, Health Care,Sectors, Healthcare
D035843 Biomedical Research Research that involves the application of the natural sciences, especially biology and physiology, to medicine. Medical Research,Experimental Medicine,Investigational Medicine,Investigative Medicine,Research, Biomedical,Research, Medical,Medicine, Experimental,Medicine, Investigational,Medicine, Investigative

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