Promoting Transparency in Pharmaceutical Industry-Sponsored Research

被引:62
作者
Ross, Joseph S. [1 ,2 ]
Gross, Cary P. [1 ,3 ]
Krumholz, Harlan M. [2 ,3 ,4 ,5 ]
机构
[1] Yale Univ, Sch Med, Gen Internal Med Sect, New Haven, CT 06520 USA
[2] Yale New Haven Med Ctr, Ctr Outcomes Res & Evaluat, New Haven, CT 06504 USA
[3] Yale Univ, Sch Med, Robert Wood Johnson Clin Scholars Program, New Haven, CT 06520 USA
[4] Yale Univ, Sch Med, Sect Cardiovasc Med, New Haven, CT 06520 USA
[5] Yale Univ, Sch Med, Sect Hlth Policy & Adm, New Haven, CT 06520 USA
关键词
CARDIOVASCULAR THROMBOTIC EVENTS; UPPER GASTROINTESTINAL TOXICITY; PUBLICATION BIAS; CLINICAL-TRIALS; RANDOMIZED-TRIALS; EMPIRICAL-EVIDENCE; REPORTING BIAS; DRUG TRIALS; ROFECOXIB; AUTHORSHIP;
D O I
10.2105/AJPH.2011.300187
中图分类号
R1 [预防医学、卫生学];
学科分类号
1004 ; 120402 ;
摘要
Strong, evidence-based practice requires that objective, unbiased research be available to inform individual clinical decisions, systematic reviews, meta-analyses, and expert guideline recommendations. Industry has used seeding trials, publication planning, messaging, ghostwriting, and selective publication and reporting of trial outcomes to distort the medical literature and undermine clinical trial research by obscuring information relevant to patients and physicians. Policies that promote transparency in the clinical trial research process, through improved and expanded disclosure of investigator contributions and funding, comprehensive publicly available trial registration, and independent analysis of clinical trial data analysis may address these subversive practices by improving accountability among industry and investigators. Minimizing marketing's impact on clinical trial research and strengthening the science will protect medical literature's integrity and the public's health. (Am J Public Health. 2012:72-80. doi :10.2105/AJPH.2011.300187)
引用
收藏
页码:72 / 80
页数:9
相关论文
共 77 条
[1]   Association of funding and conclusions in randomized drug trials - A reflection of treatment effect or adverse events? [J].
Als-Nielsen, B ;
Chen, WD ;
Gluud, C ;
Kjaergard, LL .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2003, 290 (07) :921-928
[2]  
Angell M., 2004, TRUTH DRUG CO THEY D, V1st ed.
[3]   Scope and impact of financial conflicts of interest in biomedical research - A systematic review [J].
Bekelman, JE ;
Li, Y ;
Gross, CP .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2003, 289 (04) :454-465
[4]  
Bhandari M, 2004, CAN MED ASSOC J, V170, P477
[5]   Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. [J].
Bombardier, C ;
Laine, L ;
Reicin, A ;
Shapiro, D ;
Burgos-Vargas, R ;
Davis, B ;
Day, R ;
Ferraz, MB ;
Hawkey, CJ ;
Hochberg, MC ;
Kvien, TK ;
Schnitzer, TJ ;
Weaver, A .
NEW ENGLAND JOURNAL OF MEDICINE, 2000, 343 (21) :1520-1528
[6]   The dirt on coming clean: Perverse effects of disclosing conflicts of interest [J].
Cain, DM ;
Loewenstein, G ;
Moore, DA .
JOURNAL OF LEGAL STUDIES, 2005, 34 (01) :1-25
[7]   Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research [J].
Chan, AW ;
Krieza-Jeric, K ;
Schmid, I ;
Altman, DG .
CANADIAN MEDICAL ASSOCIATION JOURNAL, 2004, 171 (07) :735-740
[8]   Empirical evidence for selective reporting of outcomes in randomized trials -: Comparison of Protocols to published articles [J].
Chan, AW ;
Hróbjartsson, A ;
Haahr, MT ;
Gotzsche, PC ;
Altman, DG .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2004, 291 (20) :2457-2465
[9]   Expression of concern: Bombardier et al., "Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis," N Engl J Med 2000;343:1520-8 [J].
Curfman, GD ;
Morrissey, S ;
Drazen, JM .
NEW ENGLAND JOURNAL OF MEDICINE, 2005, 353 (26) :2813-2814
[10]   Between the lines: Navigating the uncharted territory of industry-sponsored research [J].
Davidoff, F .
HEALTH AFFAIRS, 2002, 21 (02) :235-242