High-impact trials with genetic and -omics information focus on cancer mutations, are industry-funded and less transparent

• Published in: Journal of clinical epidemiology 2025-01, p.111676, Article 111676
• Main Authors: Russo, Luigi, Siena, Leonardo M., Farina, Sara, Pastorino, Roberta, Boccia, Stefania, Ioannidis, John P.A.
• Format: Article
• Language: English
• Subjects: clinical trials; Genetics; genomics; industry; transparency
• ISSN: 0895-4356; 1878-5921; 1878-5921
• DOI: 10.1016/j.jclinepi.2025.111676

To assess how genetics and -omics information is used in the most cited recent clinical trials, and to evaluate industry involvement and transparency patterns. This is a meta-research evaluation using a previously constructed database of the 600 most cited clinical trials published from 2019 to 2022. Trials that utilized genetic or -omics characterization of participants in the trial design, analysis, and results were considered eligible. 132 (22%) trials used genetic or -omics information, predominantly for detection of cancer mutations (n=101). Utilization included eligibility criteria (n=59), subgroup analysis (n=82), and stratification factor in randomization (n=14). Authors addressed the relevance in the conclusions in 82 studies (62%). 102 studies (77%) provided data availability statements and 6 had data already available. Most studies had industry funding (n=111 [84.0%]). Oncology trials were more likely to be industry-funded (90.1% vs 64.5%, p=0.001), to have industry-affiliated analysts (43.6% vs 22.6%, p=0.036) and to favor industry-sponsored interventions (83.2% vs 58.1% p=0.004). When compared to other trials, genetic and -omics trials were more likely to be funded by industry (84% vs 63.9%, p