JAMA - Financial Conflicts of Interest in Biomedical Research

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http://jama.ama-assn.org/issues/v289n4/abs/jrv20091.html

 

Scope and Impact of Financial Conflicts of Interest in Biomedical Research

 

A Systematic Review

 

Justin E. Bekelman, AB; Yan Li, MPhil; Cary P. Gross, MD

 

 

 

Context Despite increasing awareness about the potential impact of financial

conflicts of interest on biomedical research, no comprehensive synthesis of the

body of evidence relating to financial conflicts of interest has been performed.

 

Objective To review original, quantitative studies on the extent, impact, and

management of financial conflicts of interest in biomedical research.

 

Data Sources Studies were identified by searching MEDLINE (January 1980-October

2002), the Web of Science citation database, references of articles, letters,

commentaries, editorials, and books and by contacting experts.

 

Study Selection All English-language studies containing original, quantitative

data on financial relationships among industry, scientific investigators, and

academic institutions were included. A total of 1664 citations were screened,

144 potentially eligible full articles were retrieved, and 37 studies met our

inclusion criteria.

 

Data Extraction One investigator (J.E.B.) extracted data from each of the 37

studies. The main outcomes were the prevalence of specific types of industry

relationships, the relation between industry sponsorship and study outcome or

investigator behavior, and the process for disclosure, review, and management of

financial conflicts of interest.

 

Data Synthesis Approximately one fourth of investigators have industry

affiliations, and roughly two thirds of academic institutions hold equity in

start-ups that sponsor research performed at the same institutions. Eight

articles, which together evaluated 1140 original studies, assessed the relation

between industry sponsorship and outcome in original research. Aggregating the

results of these articles showed a statistically significant association between

industry sponsorship and pro-industry conclusions (pooled Mantel-Haenszel odds

ratio, 3.60; 95% confidence interval, 2.63-4.91). Industry sponsorship was also

associated with restrictions on publication and data sharing. The approach to

managing financial conflicts varied substantially across academic institutions

and peer-reviewed journals.

 

Conclusions Financial relationships among industry, scientific investigators,

and academic institutions are widespread. Conflicts of interest arising from

these ties can influence biomedical research in important ways.

 

JAMA. 2003;289:454-465

 

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Author/Article Information

 

 

 

Author Affiliations: Department of Medicine (Mr Bekelman and Dr Gross) and

Department of Biostatistics (Ms Li), Yale University School of Medicine, New

Haven, Conn.

 

Corresponding Author and Reprints: Cary P. Gross, MD, Primary Care Center, Yale

University School of Medicine, 333 Cedar St, PO Box 208025, New Haven, CT 06520

(e-mail: cary.gross).

 

Author Contributions: Study concept and design: Bekelman, Gross.

 

Acquisition of data: Bekelman.

 

Analysis and interpretation of data: Bekelman, Li, Gross.

 

Drafting of the manuscript: Bekelman.

 

Critical revision of the manuscript for important intellectual content:

Bekelman, Li, Gross.

 

Statistical expertise: Li.

 

Study supervision: Gross.

 

Funding/Support: Mr Bekelman was the recipient of a short-term research

fellowship from the Office of Student Research at Yale University School of

Medicine.

 

Acknowledgment: We thank Patrick O'Connor, MD, and Michael Farrell, MD, for

their comments and suggestions in the preparation of this article.

 

Financial Disclosures: Dr Gross has served as a consultant and scientific

advisory board member to Astra-Zeneca. Mr Bekelman has served as a consultant to

Turbogenomics Inc.

 

 

 

 

 

 

 

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