TY - JOUR
T1 - Development of clinical trials in a cooperative group setting
T2 - The eastern cooperative oncology group
AU - Dilts, David M.
AU - Sandler, Alan
AU - Cheng, Steven
AU - Crites, Joshua
AU - Ferranti, Lori
AU - Wu, Amy
AU - Gray, Robert
AU - MacDonald, Jean
AU - Marinucci, Donna
AU - Comis, Robert
N1 - Copyright:
Copyright 2011 Elsevier B.V., All rights reserved.
PY - 2008/6/1
Y1 - 2008/6/1
N2 - 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.
AB - 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.
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U2 - 10.1158/1078-0432.CCR-07-5060
DO - 10.1158/1078-0432.CCR-07-5060
M3 - Article
C2 - 18519773
AN - SCOPUS:50349099021
VL - 14
SP - 3427
EP - 3433
JO - Clinical Cancer Research
JF - Clinical Cancer Research
SN - 1078-0432
IS - 11
ER -