This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Dilts, D. M. Articles by Comis, R. Search for Related Content PubMed PubMed Citation Articles by Dilts, D. M. Articles by Comis, R.

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.

This article has been cited by other articles:

				D. M. Dilts, A. B. Sandler, S. K. Cheng, J. S. Crites, L. B. Ferranti, A. Y. Wu, S. Finnigan, S. Friedman, M. Mooney, and J. Abrams Steps and Time to Process Clinical Trials at the Cancer Therapy Evaluation Program J. Clin. Oncol., April 10, 2009; 27(11): 1761 - 1766. [Abstract] [Full Text] [PDF]

				D. P. Steensma The Ordinary Miracle of Cancer Clinical Trials J. Clin. Oncol., April 10, 2009; 27(11): 1737 - 1739. [Full Text] [PDF]