Development of clinical trials in a cooperative group setting: the eastern cooperative oncology group.
OBJECTIVE
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.


CONCLUSIONS
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.
Dilts
David M
DM
Owen Graduate School of Management and Engineering Management Program, School of Engineering, Vanderbilt University, 401 21st Avenue South, Nashville, TN 37203, USA. David.dilts@vanderbilt.edu
Sandler
Alan
A
Cheng
Steven
S
Crites
Joshua
J
Ferranti
Lori
L
Wu
Amy
A
Gray
Robert
R
MacDonald
Jean
J
Marinucci
Donna
D
Comis
Robert
R
D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D006801:Humans; D015337:Multicenter Studies as Topic; D009369:Neoplasms / Q000628:therapy*; D017064:Process Assessment, Health Care; D012107:Research Design; D013995:Time