- Improve the speed and efficiency of trial development and conduct.
- Incorporate innovative science and trial design.
- Improve trial prioritization, selection, support, and completion.
- Ensure participation of patients and physicians in the system.
A Closer Look
Cancer Clinical Trials System Restructuring Moves Forward
The restructuring of NCI's clinical trials program took another step forward last month when NCI's Board of Scientific Advisors (BSA) approved a proposal to fund a new integrated NCI Clinical Trials Network (NCTN). The proposal builds on existing efforts at NCI to enhance the efficacy and efficiency of the clinical trials program.
Under the proposal, NCI would fund no more than five clinical trials groups (up to four adult groups and one pediatric group), as well as centers to provide support for core services, such as imaging and radiation therapy. The funding would also support investigators whose focus will be on incorporating molecular research studies and other translational research into NCTN trials.
The proposed restructuring aims to enhance the participation of NCI-designated cancer centers and other leading academic medical centers in NCTN clinical trials. A cornerstone of this effort is higher per-patient reimbursement from NCI for high-performing centers, that is, centers that meet performance benchmarks in areas such as accrual to clinical treatment trials and data quality.
According to a timeline presented during the meeting, NCI and NIH will review and refine the proposal through early 2012, with the expectation that funding announcements for participation in the network will be released by the summer of 2012. Grants for network participation will be awarded in the spring of 2014.
Responding to the Call
Although questions were raised about the proposal at the BSA meeting, such as whether the restructuring would affect the role of advocates in the system and access to genomic data, BSA members welcomed the proposal, saying it addresses many of the issues that have been raised by numerous groups and that were highlighted in a 2010 Institute of Medicine (IOM) report commissioned by NCI.
A more integrated, streamlined clinical trials system will help provide answers to pressing clinical questions sooner and more efficiently than has been possible in the past, said Dr. Michael Caligiuri, director of the Ohio State University Comprehensive Cancer Center, who chaired a BSA subcommittee on restructuring the clinical trials system. "This will allow us to get to the goal line more quickly," Dr. Caligiuri said. "That's how we cure cancer."
The restructuring is centered around the four overarching goals for the program laid out in the IOM report and by numerous stakeholders in the NCI clinical trials program, such as improving the speed and efficiency with which trials are developed and conducted, explained Dr. Margaret Mooney, chief of the Clinical Investigations Branch in NCI's Division of Cancer Treatment and Diagnosis (DCTD).
Consensus Goals for a Transformed NCI Clinical Trials System
Through existing efforts, such as tight adherence to timelines for progress in certain areas, the time it takes to launch a trial has already been cut in half. Further improvements should be possible, said Dr. Jeff Abrams, acting director of clinical research in DCTD.
One component that should help trials run more efficiently is a common patient data management system that is currently being implemented. All sites participating in future network clinical trials will use this single electronic system to capture and transmit patient data, which Dr. Mooney said can also provide benefits in areas such as data analysis and regulatory compliance.
In response to the IOM report and NCI's announced intention to fund fewer groups under NCI's new network clinical trials program, the existing cooperative groups have already begun to merge.
Earlier this year, the Cancer and Leukemia Group B, North Central Cancer Treatment Group, and American College of Surgeons Oncology Group announced that they were merging to form the Alliance for Clinical Trials in Oncology. The American College of Radiology Imaging Network and the Eastern Cooperative Oncology Group are also merging, as are the National Surgical Adjuvant Breast and Bowel Project, Radiation Therapy Oncology Group, and Gynecologic Oncology Group.
A key facet of the proposal is the consolidation of the clinical trials groups from 10 to no more than 5—a process that has already begun. This consolidation should help to improve recruitment, reduce redundancies, and provide economies of scale in areas such as information technology systems and regulatory activities, according to Dr. Mooney.
Just as important, new review criteria for clinical trial approval will likely translate into more trials for cancer types that have been typically underrepresented relative to their incidence, Dr. Mooney noted. A new subcommittee of NCI's Clinical Trials and Translational Research Advisory Committee will be charged with ensuring that important opportunities to address less common tumors "are not missed," she added.
Greater Cancer Center Involvement
Committee members were particularly pleased with the proposal to increase reimbursement to centers for enrolling patients in NCTN trials. Although health care costs have risen dramatically, far outstripping standard inflation, per-patient reimbursement for NCI cooperative group trials has remained at $2,000 for the last decade. Reimbursement for industry-sponsored trials is often three to five times that amount.
Under the proposal, per-patient reimbursement would rise by $2,000 for high-performing centers. The reimbursement increase is desperately needed, said Dr. Robert Diasio, director of the Mayo Clinic Cancer Center, during the BSA meeting. Low reimbursement has "made it completely unrealistic for many [cancer centers] to participate" in NCI cooperative group trials, he said.
Covering the higher reimbursement within the trial network's proposed budget, however, will mean that fewer patients will be enrolled in network group trials—a decline from approximately 25,000 patients enrolled annually to about 20,000.
"Increasing reimbursement means we'll have to focus even harder on prioritizing what trials we go forward with," Dr. Mooney said.
Cancer centers and other academic centers will also be able to compete for grants called U10 awards that will be awarded and managed by principal investigators at individual centers. Under the current system, such grants are managed through the individual cooperative groups with which cancer centers are aligned. In the integrated network, investigators at academic centers that receive the U10 awards have an incentive to enroll patients in any open network group trial, Dr. Caligiuri stressed.
With this approach, "the patient gets a smorgasbord of trials to choose from, regardless of which group is leading the trial," he continued, "and the investigator has every incentive to place patients on the trials that are most appropriate for them."
For more information, watch a videocast of the recent BSA meeting on the NIH website.