Guest Director's Update
Improving the Efficiency of Clinical Trials: Decreasing Activation Times by Fifty Percent
NCI is dedicated to bringing new therapeutic and diagnostic options to patients with cancer as quickly as possible. On average, 25,000 to 30,000 patients per year are accrued to NCI-supported clinical trials through several networks of institutions and clinical trialists.
However, the current process of activating new phase III clinical trials conducted by NCI’s cooperative groups averages more than 2 years; and the time to activate most phase I and II studies requires more than 500 days. A recent analysis of NCI’s clinical trials activation process demonstrated that many trials, especially those that took the longest to open, never reached their accrual goals and had to be closed, wasting precious time and resources. The analysis also showed that the complex path to trial activation was characterized by steps that did not ultimately add value to the clinical trial itself.
To dramatically improve the current situation, NCI’s Clinical and Translational Research Advisory Committee (CTAC) initiated a review of the clinical trial activation process. On March 23, CTAC’s Operational Efficiency Working Group (OEWG) presented its final report, outlining a series of recommended changes to NCI’s current clinical trials activation procedures. These changes aim to decrease by half the time it takes to initiate new clinical studies.
The OEWG, whose 63 members were drawn from cancer research in academia, clinical practice, industry, and government, as well as the advocacy community, began its deliberations in December 2008; the report from this broadly representative group outlines 14 initiatives and implementation plans that describe both target dates and hard deadlines for the initiation of new clinical trials.
These initiatives are targeted at improving activation processes within the cooperative groups, the cancer centers, and institutions conducting early-phase trials. The OEWG set a target of 300 days for the time between submitting a phase III concept to the NCI Cancer Therapy Evaluation Program (CTEP) and the time of trial activation. Phase III trials will be terminated if they are not activated in 24 months. For phase I and II studies, the target for submission to opening is 210 days, with a drop-dead date for activation of 18 months.
To achieve these timelines, the report recommends:
- Dedicated clinical trial development managers for protocol activation duties
- Real-time project tracking systems that monitor where a concept or protocol is in the review process and who the responsible party is for that stage of the process
- More support for protocol development, including dedicated medical writers who may be able to reduce the number of protocol revisions
- Policies and procedures that coordinate interactions between group members, phase I/II trialists, and CTEP
Because of the consensus development that occurred during the writing of the report, many of the recommended initiatives are already being implemented. Administrative supplements are being awarded to all of the cooperative groups to help them develop action plans, hire appropriate staff, and acquire and begin using appropriate project tracking tools. Supplement requests for 48 of the NCI-designated cancer centers are currently under review. CTEP has also developed its own action plan to improve efficiency and speed protocol activation through more coordinated, real-time interactions with the clinical trials community. These changes were initiated as of April 1, 2010. The new timeliness deadlines for trial termination will become effective on January 1, 2011.
The OEWG report calls for all those involved in clinical trials, both inside and outside of NCI, to interact more effectively and to coordinate all of the tasks in the clinical trial development process in the most efficient manner possible. We owe our patients nothing less.
I was very fortunate to co-chair the OEWG with Dr. Gabriel Hortobagyi of the University of Texas M. D. Anderson Cancer Center. I would like to take this opportunity to express my appreciation to him for his extraordinary commitment to this effort. We both consider the implementation of the OEWG recommendations to be of the utmost importance for cancer patients everywhere.
James H. Doroshow
Director, NCI Division of Cancer Treatment and Diagnosis