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Updated: Jun 25, 2026
10:49
Pre-clinical Evaluation of Tyrosine Kinase Inhibitors for Treatment of Acute Leukemia
Published on: September 18, 2013
Steps and time to process clinical trials at the Cancer Therapy Evaluation Program.
David M Dilts1, Alan B Sandler, Steven K Cheng
1Center for Management Research in Healthcare, Vanderbilt University, Nashville, TN 37235-1518, USA.
Summary
Activating phase III clinical trials involves over 296 complex processes, taking a median of 602 days. Streamlining this lengthy and variable process requires collaboration among all involved parties.
Area of Science:
- Oncology
- Clinical Trial Management
- Regulatory Science
Background:
- Phase III clinical trials are crucial for cancer treatment evaluation.
- The National Cancer Institute's Cancer Therapy Evaluation Program (CTEP) and Central Institutional Review Board (CIRB) oversee trial approvals.
- Understanding the activation timeline is essential for efficient drug development.
Purpose of the Study:
- To meticulously document the processes involved in phase III clinical trial activation.
- To quantify the calendar time from initial concept to trial activation by CTEP and CIRB.
- To identify bottlenecks and variations in the trial approval process.
Main Methods:
- Process mapping through staff interviews and standard operating procedure review.
- Analysis of trial records to identify all activation steps.
- Retrospective data collection on calendar time from concept submission to activation.
Main Results:
- A minimum of 296 distinct processes, including 239 working steps and 52 decision points, are required for trial activation.
- The median time from concept submission to activation was 602 days (IQR: 454-861).
- This activation time has remained consistent over an 8-year period, exhibiting significant variability.
Conclusions:
- Phase III clinical trial development is inherently complex, time-consuming, and highly variable.
- The current process requires significant streamlining to improve efficiency.
- A collaborative approach involving all stakeholders is necessary to optimize trial development timelines.
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