Head-to-head randomized trials are mostly industry sponsored and almost always favor the industry sponsor

To map the current status of head-to-head comparative randomized evidence and to assess whether funding may impact on trial design and results. From a 50% random sample of the randomized controlled trials (RCTs) published in journals indexed in PubMed during 2011, we selected the trials with ≥100 pa...

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Vydáno v:	Journal of clinical epidemiology Ročník 68; číslo 7; s. 811 - 820
Hlavní autoři:	Flacco, Maria Elena, Manzoli, Lamberto, Boccia, Stefania, Capasso, Lorenzo, Aleksovska, Katina, Rosso, Annalisa, Scaioli, Giacomo, De Vito, Corrado, Siliquini, Roberta, Villari, Paolo, Ioannidis, John P.A.
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	United States Elsevier Inc 01.07.2015 Elsevier Limited
Témata:	Asia Clinical trials Confidence intervals Conflict of Interest Corporate sponsorship Cross-sectional study Drug Industry - economics Empirical Research Epidemiology Europe Head-to-head comparison Industry sponsorship Internal Medicine Internationality Intervention Medical equipment Medical practices Noninferiority trials Patient Selection Randomized controlled trials Randomized Controlled Trials as Topic - economics Research Design Research Support as Topic - methods Research Support as Topic - organization & administration Research Support as Topic - statistics & numerical data Studies United States Asia United States Europe Noninferiority trials Cross-sectional study Industry sponsorship Conflict of interest Head-to-head comparison Randomized controlled trials
ISSN:	0895-4356, 1878-5921
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Popis
Shrnutí:	To map the current status of head-to-head comparative randomized evidence and to assess whether funding may impact on trial design and results. From a 50% random sample of the randomized controlled trials (RCTs) published in journals indexed in PubMed during 2011, we selected the trials with ≥100 participants, evaluating the efficacy and safety of drugs, biologics, and medical devices through a head-to-head comparison. We analyzed 319 trials. Overall, 238,386 of the 289,718 randomized subjects (82.3%) were included in the 182 trials funded by companies. Of the 182 industry-sponsored trials, only 23 had two industry sponsors and only three involved truly antagonistic comparisons. Industry-sponsored trials were larger, more commonly registered, used more frequently noninferiority/equivalence designs, had higher citation impact, and were more likely to have “favorable” results (superiority or noninferiority/equivalence for the experimental treatment) than nonindustry-sponsored trials. Industry funding [odds ratio (OR) 2.8; 95% confidence interval (CI): 1.6, 4.7] and noninferiority/equivalence designs (OR 3.2; 95% CI: 1.5, 6.6), but not sample size, were strongly associated with “favorable” findings. Fifty-five of the 57 (96.5%) industry-funded noninferiority/equivalence trials got desirable “favorable” results. The literature of head-to-head RCTs is dominated by the industry. Industry-sponsored comparative assessments systematically yield favorable results for the sponsors, even more so when noninferiority designs are involved.
Bibliografie:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 ObjectType-Article-2 ObjectType-Feature-1 ObjectType-Review-3 content type line 23
ISSN:	0895-4356 1878-5921
DOI:	10.1016/j.jclinepi.2014.12.016