Journal Article

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

Flacco, Maria Elena, Siliquini, Roberta, Scaioli, Giacomo, Capasso, Lorenzo, Aleksovska, Katina, Boccia, Stefania, Rosso, Annalisa, Ioannidis, John P.A., De Vito, Corrado, Manzoli, Lamberto, Villari, Paolo

2015

Overview

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.

• Publisher: Elsevier Inc,Elsevier Limited
• Subject: 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