Investigator experiences with financial conflicts of interest in clinical trials

被引：23

作者：

Rochon, Paula A. ^{[1
,2
]}

Sekeres, Melanie ^{[3
]}

Hoey, John ^{[4
]}

Lexchin, Joel ^{[5
,6
,7
]}

Ferris, Lorraine E. ^{[4
]}

Moher, David ^{[8
]}

Wu, Wei ^{[1
,2
]}

Kalkar, Sunila R. ^{[1
,2
]}

Van Laethem, Marleen ^{[9
,10
]}

Gruneir, Andrea ^{[1
,2
]}

Gold, Jennifer ^{[11
]}

Maskalyk, James ^{[12
]}

Streiner, David L. ^{[13
]}

Taback, Nathan ^{[4
]}

Chan, An-Wen ^{[1
,2
]}

机构：

[1] Womens Coll Res Inst, Toronto, ON, Canada

[2] Womens Coll Hosp, Toronto, ON M5S 1B2, Canada

[3] Univ Toronto, Dept Physiol, Toronto, ON, Canada

[4] Univ Toronto, Dalla Lana Sch Publ Hlth, Toronto, ON, Canada

[5] York Univ, Sch Hlth Policy & Management, Toronto, ON M3J 2R7, Canada

[6] Univ Hlth Network, Emergency Dept, Toronto, ON, Canada

[7] Univ Toronto, Dept Family & Community Med, Toronto, ON M5S 1A1, Canada

[8] Univ Ottawa, Fac Med, Dept Epidemiol & Community Med, Clin Epidemiol Methods Ctr,Ottawa Hlth Res Inst, Ottawa, ON, Canada

[9] Toronto Rehabil Inst, Toronto, ON, Canada

[10] Univ Toronto, Joint Ctr Bioeth, Toronto, ON, Canada

[11] Ontario Med Assoc, Toronto, ON, Canada

[12] Univ Toronto, Div Emergency Med, Toronto, ON, Canada

[13] Univ Toronto, Dept Psychiat, Toronto, ON, Canada

来源：

TRIALS | 2011年 / 12卷

基金：

加拿大健康研究院;

关键词：

REGISTRATION; AGREEMENTS; STANDARDS;

D O I：

10.1186/1745-6215-12-9

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

Background: Financial conflicts of interest (fCOI) can introduce actions that bias clinical trial results and reduce their objectivity. We obtained information from investigators about adherence to practices that minimize the introduction of such bias in their clinical trials experience. Methods: Email survey of clinical trial investigators from Canadian sites to learn about adherence to practices that help maintain research independence across all stages of trial preparation, conduct, and dissemination. The main outcome was the proportion of investigators that reported full adherence to preferred trial practices for all of their trials conducted from 2001-2006, stratified by funding source. Results: 844 investigators responded (76%) and 732 (66%) provided useful information. Full adherence to preferred clinical trial practices was highest for institutional review of signed contracts and budgets (82% and 75% of investigators respectively). Lower rates of full adherence were reported for the other two practices in the trial preparation stage (avoidance of confidentiality clauses, 12%; trial registration after 2005, 39%). Lower rates of full adherence were reported for 7 practices in the trial conduct (35% to 43%) and dissemination (53% to 64%) stages, particularly in industry funded trials. 269 investigators personally experienced (n = 85) or witnessed (n = 236) a fCOI; over 70% of these situations related to industry trials. Conclusion: Full adherence to practices designed to promote the objectivity of research varied across trial stages and was low overall, particularly for industry funded trials.

引用

页数：9

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