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

Abstract

Objectives

To assess how genetics and -omics information is used in the most cited recent clinical trials and to evaluate industry involvement and transparency patterns.

Study Design and Setting

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.

Results

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 six 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 = .001), to have industry-affiliated analysts (43.6% vs 22.6%, P = .036), and to favor industry-sponsored interventions (83.2% vs 58.1% P = .004). When compared to other trials, genetic and -omics trials were more likely to be funded by industry (84% vs 63.9%, P < .001) and tended to be less likely to have full protocols (P = .018) and statistical plans (P = .04) available.

Conclusion

Our study highlights the current underutilization of genetic and -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.