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J Clin Epidemiol. 2015 Jul;68(7):811-20. doi: 10.1016/j.jclinepi.2014.12.016. Epub 2015 Feb 7.

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

Author information

1
Department of Medicine and Aging Sciences, University of Chieti, Via dei Vestini 5, 66013 Chieti, Italy; Regional Healthcare Agency of the Abruzzo Region, Via Attilio Monti 9, 65127 Pescara, Italy.
2
Department of Medicine and Aging Sciences, University of Chieti, Via dei Vestini 5, 66013 Chieti, Italy; Regional Healthcare Agency of the Abruzzo Region, Via Attilio Monti 9, 65127 Pescara, Italy; CEsI Biotech, Foundation "Università G. d'Annunzio" of Chieti, Via dei Vestini 31, 66013 Chieti, Italy. Electronic address: lmanzoli@post.harvard.edu.
3
Institute of Public Health, Catholic University of the Sacred Heart, Largo Francesco Vito 1, 00168 Rome, Italy.
4
Department of Medicine and Aging Sciences, University of Chieti, Via dei Vestini 5, 66013 Chieti, Italy; CEsI Biotech, Foundation "Università G. d'Annunzio" of Chieti, Via dei Vestini 31, 66013 Chieti, Italy.
5
Department of Public Health and Infectious Diseases, Sapienza University of Rome, Piazzale Aldo Moro 5, 00185 Rome, Italy.
6
Department of Public Health Sciences, University of Turin, Via Verdi 8, 10124 Turin, Italy.
7
Departments of Medicine and Health Research and Policy, Stanford Prevention Research Center, Stanford University School of Medicine, 291 Campus Drive, Stanford, CA 94305, USA.

Abstract

OBJECTIVES:

To map the current status of head-to-head comparative randomized evidence and to assess whether funding may impact on trial design and results.

STUDY DESIGN AND SETTING:

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.

RESULTS:

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.

CONCLUSION:

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.

KEYWORDS:

Conflict of interest; Cross-sectional study; Head-to-head comparison; Industry sponsorship; Noninferiority trials; Randomized controlled trials

PMID:
25748073
DOI:
10.1016/j.jclinepi.2014.12.016
[Indexed for MEDLINE]
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