Flacco ME, Manzoli L, Boccia S, Capasso L, Aleksovska K, Rosso A, Scaioli G, De Vito C, Siliquini R, Villari P, Ioannidis JP.
Head-to-head randomized trials are mostly industry sponsored and almost always favour the industry sponsor.J Clin Epidemiol. 2015;68(7):811-820.
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 non industry-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 non inferiority designs are involved.
You say which drug is best and I say I don't know. You need to do a head to head study and see which is the best or a non-inferiority study to show it is no worse. However in the published trials the pharma drugs always succeed. Go figure. This is because when pharma do head to heads they target the low hanging fruit so they can put their marketing departments on the job. Now if they put their drugs against generic cladribine would this change the status
Labels: Drug development