Phase III clinical trial development: A process of chutes and ladders

David Dilts, Steven K. Cheng, Joshua S. Crites, Alan B. Sandler, James H. Doroshow

Research output: Contribution to journalArticle

45 Scopus citations


Purpose: The Institute of Medicine report on cooperative groups and the National Cancer Institute (NCI) report from the Operational Efficiency Working Group both recommend changes to the processes for opening a clinical trial. This article provides evidence for the need for such changes by completing the first comprehensive review of all the time and steps required to open a phase III oncology clinical trial and discusses the effect of time to protocol activation on subject accrual. Methods: The Dilts and Sandler method was used at four cancer centers, two cooperative groups, and the NCI Cancer Therapy Evaluation Program. Accrual data were also collected. Results: Opening a phase III cooperative group therapeutic trial requires 769 steps, 36 approvals, and a median of approximately 2.5 years from formal concept review to study opening. Time to activation at one group ranged from 435 to 1,604 days, and time to open at one cancer center ranged from 21 to 836 days. At centers, group trials are significantly more likely to have zero accruals (38.8%) than non-group trials (20.6%; P <0.0001). Of the closed NCI Cancer Therapy Evaluation Program-approved phase III clinical trials from 2000 to 2007, 39.1% resulted in

Original languageEnglish (US)
Pages (from-to)5381-5389
Number of pages9
JournalClinical Cancer Research
Issue number22
Publication statusPublished - Nov 15 2010


ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Dilts, D., Cheng, S. K., Crites, J. S., Sandler, A. B., & Doroshow, J. H. (2010). Phase III clinical trial development: A process of chutes and ladders. Clinical Cancer Research, 16(22), 5381-5389.