Cancer and Leukemia Group B/Southwest Oncology Group Trial 80405: A Phase III Trial of Chemotherapy and Biologics for Patients with Untreated Advanced Colorectal Adenocarcinoma

2005 ◽  
Vol 5 (4) ◽  
pp. 292-294 ◽  
Author(s):  
Alan P. Venook ◽  
Charles D. Blanke ◽  
Donna Niedzwiecki ◽  
Heinz-Josef Lenz ◽  
John R. Taylor ◽  
...  
Keyword(s):  
Colorectal Adenocarcinoma ◽  
Phase Iii ◽  
Oncology Group ◽  
Phase Iii Trial ◽  
Southwest Oncology Group ◽  
Group B ◽  
Leukemia Group ◽  
Group Trial

Processes to Activate Phase III Clinical Trials in a Cooperative Oncology Group: The Case of Cancer and Leukemia Group B

2006 ◽  
Vol 24 (28) ◽  
pp. 4553-4557 ◽  
Author(s):  
David M. Dilts ◽  
Alan B. Sandler ◽  
Matthew Baker ◽  
Steven K. Cheng ◽  
Stephen L. George ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase Iii ◽  
Activation Process ◽  
Oncology Group ◽  
Calendar Time ◽  
Phase Iii Clinical Trials ◽  
Decision Points ◽  
Phase Iii Study ◽  
Group B ◽  
Leukemia Group

Purpose National Cancer Institute–sponsored cooperative oncology groups are major sponsors of phase III clinical trials, yet the time and steps required to design and activate such studies has not been well studied. We examine the processes and document the calendar time required to activate such studies opened by the Cancer and Leukemia Group B (CALGB). Methods Setup steps were documented by (1) interviewing CALGB headquarters and statistical center staff and committee chairs to discover the steps required to transit from concept development to final study activation, (2) reviewing procedure manuals, and (3) inspecting all study records, documents, and e-mails to identify any additional steps. Calendar time was collected for each major process. Results Thirteen phase III studies were activated by CALGB during the study period of May 2002 to May 2005. More than 370 distinct processes were required for study activation: 317 work steps, 42 decision points, and 29 processing loops. Sixty-three percent of the decision points were outside CALGB. The complete process map measures 243.5” × 41” in 8-point font. Median calendar days to activate a phase III study at CALGB was 580 days (range, 295 to 1,248 days) from concept approval and 784 days (range, 537 to 1,130 days) from initial conception of the study. Conclusion Setup of a phase III study at a major cooperative oncology group is a complex and lengthy process, with the majority of decision points external to the cooperative group. To improve the activation process, research should to be directed toward both internal and external groups and processes.

A phase III trial of etoposide and cisplatin in extensive small cell lung cancer: A cancer and Leukemia Group B study

Lung Cancer ◽  
1996 ◽  
Vol 15 (2) ◽  
pp. 215-223 ◽  
Author(s):  
Edith P. Mitchell ◽  
Michael C. Perry ◽  
Sharon D. Luikart ◽  
Constance T. Cirrincione ◽  
David A. Van Echo ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Phase Iii ◽  
Small Cell Lung ◽  
Phase Iii Trial ◽  
Group B ◽  
Leukemia Group
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