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

SIMPLE SUMMARY: Timely execution and reporting of cancer clinical trials is important to patients and clinical researchers. Looking at a group of over three hundred cancer clinical trials with published results, we studied what factors influenced how quickly they reported their results in scientific journals. We found that trials sponsored by cooperative groups tended to report more slowly on average, while industry-funded trials reported more quickly. Additionally, we found that even after accounting for other variables that might affect timely reporting—such as whether a trial was successful, the type of cancer studied, or what type of intervention was studied—industry-funded trials still reported more quickly on average than non-industry funded trials. The reasons for these differences in reporting times are important to understand because trial results affect patient care and ongoing clinical research endeavors. 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.