Trial Sponsorship and Time to Reporting for Phase 3 Randomized Cancer Clinical Trials

Abstract

The pace of clinical trial data generation and publication is an area of interest within clinical oncology; however, little is known about the dynamics and covariates of time to reporting (TTR) of trial results. To assess these, ClinicalTrials.gov was queried for phase three clinical trials for patients with metastatic solid tumors, and the factors associated with TTR from enrollment completion to publication were analyzed. Based on the 319 included trials, cooperative-group-sponsored trials were reported at a slower rate than non-cooperative-group trials (median 37.5 vs. 31.0 months; p < 0.001), while industry-funded studies were reported at a faster rate than non-industry-supported trials (31.0 vs. 40.0 months; p = 0.005). Furthermore, successful trials (those meeting their primary endpoint) were reported at a faster rate than unsuccessful studies (27.5 vs. 36.0 months; p < 0.001). Multivariable analysis confirmed that industry funding was independently associated with a shorter TTR (p = 0.006), while cooperative group sponsorship was not associated with a statistically significant difference in TTR (p = 0.18). These data underscore an opportunity to improve cooperative group trial efficiency by reducing TTR.

Prevalence, trends, and characteristics of trials investigating local therapy in contemporary phase 3 clinical cancer research

“…It is important to note that this study does not suggest that there are inherent differences between the research of for‐profit and nonprofit funding sources, and for‐profit sources are important vehicles for innovation. The above findings do, however, raise questions about the influence of funding sources in oncology research and how anticipated revenue streams may impact the types of trials conducted as well as their design, accrual, reporting, and outcomes 14–20 ,. 33‐40 In recent years, the majority of phase 3 trials have been funded by industry 14,41,42 .…”

“…Notably, the study aim was to evaluate the trends of completed, published late‐phase trials that are currently impacting contemporary clinical practice. As such, this study does not directly address the interesting, but separate, question of how therapeutic modality relates to current phase 3 trial design, as the timeline from conception of a phase 3 trial to publication is heterogenous and may systematically differ based on the trial sponsor and trial modality; moreover, recent data demonstrate that one in 15 completed oncology randomized controlled trials are not published 17,47 . Trials published after the data collection date were not included in the study, and the study findings must be interpreted with this in mind.…”

“…Numerous studies have examined trends of late‐phase research such as funding, leadership, impact factor, and outcomes reporting, among other topics 7 ,. 12–21 However, although the majority of patients with cancer are treated with LT at some point during the cancer care continuum, the proportion of late‐phase clinical trials investigating LT remains unknown 22,23 …”

Industry Involvement and Transparency in the Most Cited Clinical Trials, 2019-2022

“…12 Industry trials may thus have competitive advantages in quality and timeliness. 13,14 Nevertheless, what is less recognized is the high penetration of industry authors and analysts in industry-funded trials. Previous work had suggested that there was a high rate of ghost authorship in clinical trials.…”

“…Industry mobilizes resources, expertise, and infrastructure for clinical trials, while public funding is limited . Industry trials may thus have competitive advantages in quality and timeliness . Nevertheless, what is less recognized is the high penetration of industry authors and analysts in industry-funded trials.…”