title: Lack of timely accrual information in oncology clinical trials: a cross-sectional analysis.
abstract: BACKGROUND
  Poor accrual is a significant barrier to the successful completion of oncology clinical trials; half of all phase 3 oncology trials close due to insufficient accrual. Timely access to accrual data fosters an understanding of successful trial design and can be used to inform the design of new clinical trials prospectively. Accrual statistics are available within research networks, such as the cancer cooperative groups, but comprehensive data reflecting the overall portfolio of cancer clinical trials are lacking. As a demonstration case, the purpose of this study was to quantify the public availability of accrual data across all recent renal cell carcinoma (RCC) trials.
  
  
  METHODS
  The database for the Aggregate Analysis of ClinicalTrials.gov (AACT) summarizes all trials registered between October 2007 and September 2010. In total, 108 trials of pharmacologic therapy for RCC were included. Accrual data on these trials were gathered via ClinicalTrials.gov (CTG), a manual review of resulting publications, and online surveys sent to principle investigators or trial coordinators.
  
  
  RESULTS
  In total, 26% (20 of 76) of trials listing a government, academic, or cooperative group (GAC) sponsor responded to the survey vs 0% (0 of 32) of those listing only industry sponsors. Across all methods, accrual data were available for only 40% (43 of 108) of trials, including 37% (28 of 76) of GAC trials and 47% (15 of 32) of industry trials. Moreover, 87% (66 of 76) of GAC trials were ongoing (open, actively recruiting, or of unknown status) vs 75% (24 of 32) of industry trials, while 9% (10 of 108) of trials were terminated or suspended.
  
  
  CONCLUSIONS
  Despite extensive efforts (surveys, phone calls, CTG abstraction, publication searches), accurate accrual data remained inaccessible for 60% of the RCC trial cohort. While CTG reports trial results, ongoing accrual data are also critically needed. Poor access to accrual data will continue to limit attempts to develop a national summary of clinical trials metrics and to optimize the cancer clinical research portfolio.
authors.forename: Aaron P
authors.initials: AP
authors.lastname: Mitchell
authors.forename: Bradford R
authors.initials: BR
authors.lastname: Hirsch
authors.affiliation: Duke Cancer Institute & Center for Learning Health Care, Duke Clinical Research Institute 2400 Pratt St, Durham, NC 27705, USA. amy.abernethy@duke.edu.
authors.forename: Amy P
authors.initials: AP
authors.lastname: Abernethy
mesh_terms: D002292:Carcinoma, Renal Cell / Q000628:therapy*; D002986:Clinical Trials as Topic / Q000379:methods*; D003430:Cross-Sectional Studies; D057239:Early Termination of Clinical Trials; D006801:Humans; D007680:Kidney Neoplasms / Q000628:therapy*; D018579:Patient Selection; D012042:Registries; D018401:Sample Size; D013997:Time Factors; D016896:Treatment Outcome