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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Veröffentlicht in:Journal of clinical epidemiology Jg. 68; H. 7; S. 811 - 820
Hauptverfasser: 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.
Format: Journal Article
Sprache:Englisch
Veröffentlicht: United States Elsevier Inc 01.07.2015
Elsevier Limited
Schlagworte:
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
Online-Zugang:Volltext
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Zusammenfassung: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.
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ISSN:0895-4356
1878-5921
DOI:10.1016/j.jclinepi.2014.12.016