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2017 ; 356
(ä): i6770
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Financial ties of principal investigators and randomized controlled trial
outcomes: cross sectional study
#MMPMID28096109
Ahn R
; Woodbridge A
; Abraham A
; Saba S
; Korenstein D
; Madden E
; Boscardin WJ
; Keyhani S
BMJ
2017[Jan]; 356
(ä): i6770
PMID28096109
show ga
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.
|*Conflict of Interest/economics
[MESH]
|Cross-Sectional Studies
[MESH]
|Drug Industry/*economics
[MESH]
|Ethics, Research
[MESH]
|Humans
[MESH]
|Outcome Assessment, Health Care
[MESH]
|Randomized Controlled Trials as Topic/*economics
[MESH]