Development of clinical trials in a cooperative group setting: The eastern cooperative oncology group

David M. Dilts, Alan Sandler, Steven Cheng, Joshua Crites, Lori Ferranti, Amy Wu, Robert Gray, Jean MacDonald, Donna Marinucci, Robert Comis

Research output: Contribution to journalArticlepeer-review

44 Scopus citations


Purpose: We examine the processes and document the calendar time required to activate phase II and III clinical trials by an oncology group: the Eastern Cooperative Oncology Group (ECOG). Methods: Setup steps were documented by (a) interviewing ECOG headquarters and statistical center staff, and committee chairs, (b) reviewing standard operating procedure manuals, and (c) inspecting study records, documents, and e-mails to identify additional steps. Calendar time was collected for each major process for each study in this set. Results: Twenty-eight phase III studies were activated by ECOG during the January 2000 to July 2006 study period. We examined a sample from 16 of those studies in detail. More than 481 distinct processes were required for study activation: 420 working steps, 61 major decision points, 26 processing loops, and 13 stopping points. Median calendar days to activate a trial in the phase III subset was 783 days (range, 285-1,542 days) from executive approval and 808 days (range, 435-1,604 days) from initial conception of the study. Data were collected for all phase II and phase III trials activated and completed during this time period [n = 52) for which development time represented 43.9% and 54.1% of the total trial time, respectively. Conclusion: The steps required to develop and activate a clinical trial may require as much or more time than the actual completion of a trial. The data shows that to improve the activation process, research should to be directed toward streamlining both internal and external groups and processes.

Original languageEnglish (US)
Pages (from-to)3427-3433
Number of pages7
JournalClinical Cancer Research
Issue number11
StatePublished - Jun 1 2008
Externally publishedYes

ASJC Scopus subject areas

  • General Medicine


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