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Development of Clinical Trials in a Cooperative Group Setting: The Eastern Cooperative Oncology Group

Authors' Affiliations: ¹ Owen Graduate School of Management, and Engineering Management program and Center for Management Research in Healthcare, Vanderbilt University, Nashville, Tennessee; ² Vanderbilt-Ingram Cancer Center, Vanderbilt University, Nashville, Tennessee; ³ Center for Management Research in Healthcare, Vanderbilt University, Nashville, Tennessee; and ⁴ Eastern Cooperative Oncology Group, Philadelphia, Pennsylvania

Requests for reprints: David M. Dilts, Owen Graduate School of Management and Engineering Management Program, School of Engineering, Vanderbilt University, 401 21st Avenue South, Nashville, TN 37203. Phone: 615-322-2259; Fax: 615-322-7996; E-mail: David.dilts{at}vanderbilt.edu.

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.