Processes to activate phase III clinical trials in a Cooperative Oncology Group: the Case of Cancer and Leukemia Group B.

@article{Dilts2006ProcessesTA,
  title={Processes to activate phase III clinical trials in a Cooperative Oncology Group: the Case of Cancer and Leukemia Group B.},
  author={David Dilts and Alan B. Sandler and Matthew B Baker and Steven Kunyuan Cheng and Stephen L. George and Kathleen S Karas and Stephen McGuire and Gourija S Menon and Jason Reusch and Debbie Sawyer and Maren Scoggins and Amy P W Wu and Kai xi Zhou and Richard L. Schilsky},
  journal={Journal of clinical oncology : official journal of the American Society of Clinical Oncology},
  year={2006},
  volume={24 28},
  pages={4553-7}
}
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… CONTINUE READING
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