{"doi":"10.1016/j.jclinepi.2014.12.016","title":"Head-to-head randomized trials are mostly industry sponsored and almost always favor the industry sponsor","abstract":"<h4>Objectives</h4>To map the current status of head-to-head comparative randomized evidence and to assess whether funding may impact on trial design and results.<h4>Study design and setting</h4>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.<h4>Results</h4>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.<h4>Conclusion</h4>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.","journal":"Journal of Clinical Epidemiology","year":2015,"id":350,"datarank":0.7584368708022463,"base_score":5.056245805348308,"endowment":5.056245805348308,"self_citation_contribution":0.7584368708022463,"citation_network_contribution":0.0,"self_endowment_contribution":0.7584368708022463,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":156,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.2501,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2015-07-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":3356,"name":"Lamberto Manzoli","orcid":"0000-0002-8129-9344","position":1,"is_corresponding":false},{"id":3357,"name":"Stefania Boccia","orcid":"0000-0002-1864-749X","position":2,"is_corresponding":false},{"id":3358,"name":"Lorenzo Capasso","orcid":"0000-0002-9902-8577","position":3,"is_corresponding":false},{"id":3359,"name":"Katina Aleksovska","orcid":"0000-0002-2372-4453","position":4,"is_corresponding":false},{"id":3360,"name":"Annalisa Rosso","orcid":"0000-0002-0537-5130","position":5,"is_corresponding":false},{"id":3361,"name":"Giacomo Scaioli","orcid":"0000-0001-5189-1294","position":6,"is_corresponding":false},{"id":3362,"name":"Corrado De Vito","orcid":"0000-0002-7846-672X","position":7,"is_corresponding":false},{"id":3363,"name":"Roberta Siliquini","orcid":"0000-0001-7388-3965","position":8,"is_corresponding":false},{"id":3364,"name":"Paolo Villari","orcid":"0000-0002-3139-0668","position":9,"is_corresponding":false},{"id":148,"name":"John P. A. Ioannidis","orcid":"0000-0003-3118-6859","position":11,"is_corresponding":false},{"id":3355,"name":"Maria Elena Flacco","orcid":"0000-0003-1404-4314","position":0,"is_corresponding":true}],"reference_count":57,"raw_metadata":null,"created_at":"2026-03-01T18:20:47.508186Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}