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. 2017 Jan 17:356:i6770.
doi: 10.1136/bmj.i6770.

Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study

Rosa Ahn  1 , Alexandra Woodbridge  2 , Ann Abraham  2 , Susan Saba  3 , Deborah Korenstein  4 , Erin Madden  2 , W John Boscardin  2   5 , Salomeh Keyhani  6   5
Affiliations

Financial ties of principal investigators and randomized controlled trial outcomes: cross sectional study

Rosa Ahn et al. BMJ. .

Abstract

Objective: To examine the association between the presence of individual principal investigators' financial ties to the manufacturer of the study drug and the trial's outcomes after accounting for source of research funding.

Design: Cross sectional study of randomized controlled trials (RCTs).

Setting: Studies published in "core clinical" journals, as identified by Medline, between 1 January 2013 and 31 December 2013.

Participants: Random sample of RCTs focused on drug efficacy.

Main outcome measure: Association between financial ties of principal investigators and study outcome.

Results: A total of 190 papers describing 195 studies met inclusion criteria. Financial ties between principal investigators and the pharmaceutical industry were present in 132 (67.7%) studies. Of 397 principal investigators, 231 (58%) had financial ties and 166 (42%) did not. Of all principal investigators, 156 (39%) reported advisor/consultancy payments, 81 (20%) reported speakers' fees, 81 (20%) reported unspecified financial ties, 52 (13%) reported honorariums, 52 (13%) reported employee relationships, 52 (13%) reported travel fees, 41 (10%) reported stock ownership, and 20 (5%) reported having a patent related to the study drug. The prevalence of financial ties of principal investigators was 76% (103/136) among positive studies and 49% (29/59) among negative studies. In unadjusted analyses, the presence of a financial tie was associated with a positive study outcome (odds ratio 3.23, 95% confidence interval 1.7 to 6.1). In the primary multivariate analysis, a financial tie was significantly associated with positive RCT outcome after adjustment for the study funding source (odds ratio 3.57 (1.7 to 7.7). The secondary analysis controlled for additional RCT characteristics such as study phase, sample size, country of first authors, specialty, trial registration, study design, type of analysis, comparator, and outcome measure. These characteristics did not appreciably affect the relation between financial ties and study outcomes (odds ratio 3.37, 1.4 to 7.9).

Conclusions: Financial ties of principal investigators were independently associated with positive clinical trial results. These findings may be suggestive of bias in the evidence base.

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Conflict of interest statement

All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organization for the submitted work, other than that described above; no financial relationships with any organizations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

Figures

None
Fig 1 Flowchart of articles in review. *190 papers, which included 195 distinct studies
See this image and copyright information in PMC

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