Genetic and other omics-based information in the most-cited recent clinical trials

Abstract

ImportanceGenetics and other -omics technologies have long been proposed for medical research use. ObjectiveTo assess how genetics and other -omics information are used in the most cited recent clinical trials, and to evaluate industry involvement and transparency patterns. Design, Setting, ParticipantsMeta-research evaluation using a previously constructed database of the 600 most cited clinical trials published from 2019 to 2022. Main Outcome(s) and Measure(s)Utilization of genetic or other -omics information in the trial design, analysis, and results; industry involvement and transparency. Results132 (22%) trials used genetic or other -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 other -omics trials were more likely to be funded by industry (84% vs 63.9%, p<0.001) and tended to be less likely to have full protocols (p=0.018) and statistical plans (p=0.04) available. Conclusions and RelevanceOur study highlights the current underutilization of genetic and other-omics technologies beyond testing for cancer mutations. Industry involvement in these trials appears to be more substantial and transparency is more limited, raising concerns about potential bias. Key PointsO_ST_ABSQuestionC_ST_ABSHow are genetics and other -omics information used in highly impactful clinical trials, and what is the involvement of the industry in their development? Findings22% of the trials employed genetic or -omics information, with the vast majority being oncology-related and focusing on testing for mutations. Industry was more heavily involved in the funding and in the design of these trials, in particular for oncology trials. MeaningThe use of genetics and -omics is limited and needs to become more common in non-oncology trials. Industry involvement is intense in this context, highlighting the need for improvements in transparency and independence.