Nonindustry-sponsored preclinical studies on statins yield greater efficacy estimates than industry-sponsored studies: a meta-analysis
Item Type
Language
English
Abstract
Industry-sponsored clinical drug studies are associated with publication of outcomes that favor the sponsor, even when controlling for potential bias in the methods used. However, the influence of sponsorship bias has not been examined in preclinical animal studies. We performed a meta-analysis of preclinical statin studies to determine whether industry sponsorship is associated with either increased effect sizes of efficacy outcomes and/or risks of bias in a cohort of published preclinical statin studies. We searched Medline (January 1966-April 2012) and identified 63 studies evaluating the effects of statins on atherosclerosis outcomes in animals. Two coders independently extracted study design criteria aimed at reducing bias, results for all relevant outcomes, sponsorship source, and investigator financial ties. The I(2) statistic was used to examine heterogeneity. We calculated the standardized mean difference (SMD) for each outcome and pooled data across studies to estimate the pooled average SMD using random effects models. In a priori subgroup analyses, we assessed statin efficacy by outcome measured, sponsorship source, presence or absence of financial conflict information, use of an optimal time window for outcome assessment, accounting for all animals, inclusion criteria, blinding, and randomization. The effect of statins was significantly larger for studies sponsored by nonindustry sources (-1.99; 95% CI -2.68, -1.31) versus studies sponsored by industry (-0.73; 95% CI -1.00, -0.47) (p value<0.001). Statin efficacy did not differ by disclosure of financial conflict information, use of an optimal time window for outcome assessment, accounting for all animals, inclusion criteria, blinding, and randomization. Possible reasons for the differences between nonindustry- and industry-sponsored studies, such as selective reporting of outcomes, require further study.
Subject
Humans
Conflict of Interest
Drug Industry
Treatment Outcome
Animals
Atherosclerosis
Cost-Benefit Analysis
Dose-Response Relationship, Drug
Drug Evaluation, Preclinical
Hydroxymethylglutaryl-CoA Reductase Inhibitors
MEDLINE
Publication Bias
Sample Size
Publication Title
Publication Year
2014
Publication Date
2014-01
Journal abreviation
PLoS Biol.
Source
PMID: 24465178 PMCID: PMC3897361 PubMed
License
ISSN
1545-7885
Link Attachment
Physical Description
vol. 12, n. 1, pp. e1001770
Short Title
Nonindustry-sponsored preclinical studies on statins yield greater efficacy estimates than industry-sponsored studies
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Nonindustry-sponsored preclinical studies on statins yield greater efficacy estimates than industry-sponsored studies: a meta-analysis,
dans Science & Ignorance,
consulté le 21 Novembre 2024, https://ignorancestudies.inist.fr/s/science-ignorance/item/4925