Trial sponsorship and time to reporting for phase 3 randomized cancer clinical trials

Timothy A. Lin, Clifton David Fuller, Vivek Verma, Walker Mainwaring, Andres F. Espinoza, Austin B. Miller, Amit Jethanandani, Dario Pasalic, Prajnan Das, Bruce D. Minsky, Charles R. Thomas, David R. Fogelman, Vivek Subbiah, Ishwaria M. Subbiah, Ethan B. Ludmir

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish (US)
Article number2636
Pages (from-to)1-8
Number of pages8
JournalCancers
Volume12
Issue number9
DOIs
StatePublished - Sep 2020

Keywords

  • Clinical trials
  • Cooperative groups
  • Health policy
  • Industry funding

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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