The Radiation Therapy Oncology Group and the National Surgical Adjuvant Breast and Bowel Project announced March 7 that they are merging forces in "a collaborative alliance" that will conduct cancer research and apply for National Cancer Institute funding.
Their plan advances a potentially seismic shift in the landscape for the nation’s cancer clinical trials.
The shake-up began in early 2010 when the Institute of Medicine (IOM) recommended an overhaul of the National Cancer Institute (NCI)–-sponsored clinical cooperative groups. The NCI itself had requested the review of the program, noting that it had become perhaps too unwieldy and bureaucratic. Clinical trials were taking longer to complete, if they were being completed at all.
In the wake of the IOM report, the NCI decided that it wanted to whittle down the number of cooperative groups in the United States from 10 to 5. The aim is to have a new trials system in place by 2014.
Dr. Walter J. Curran
The Pittsburgh-based National Surgical Adjuvant Breast and Bowel Project (NSABP) and the Philadelphia-based Radiation Therapy Oncology Group (RTOG) said that their alliance is in direct response to the NCI plan. "The two groups believe it is in the mutual best interests of the groups and for cancer patients to form an alliance which will ultimately constitute one of these funded groups," said Dr. Walter J. Curran, chairman of the RTOG, in a statement. Dr. Curran, who is also executive director of the Winship Cancer Institute at Emory University in Atlanta, said that the details of the merger are still in development, but that the groups are hoping to "create optimal synergies between the strengths of each organization."
In the same statement, Dr. Norman Wolmark, chairman of the NSABP and director of oncology at the West Penn Allegheny Health System in the Pittsburgh area, said that the "NSABP with its internationally renowned research for patients with or at risk for breast and colorectal cancer and RTOG with its outstanding research portfolio for patients with brain tumors, digestive and respiratory cancers, and prostate cancer, complement each other in many ways."
This is the second major announcement from the NCI cooperative groups.
Even before the NCI unveiled its consolidation plan, the American College of Surgeons Oncology Group (ACOSOG), the Cancer and Leukemia Group B (CALGB), and the North Central Cancer Treatment Group (NCCTG) decided in early 2010 to integrate their statistical and data management functions. Further integration of these groups is likely, Dr. Jan C. Buckner, chairman of the NCCTG, said in an interview.
Rationale for Change
Oncologists, the NCI, and patient groups agree that the cancer clinical trial enterprise has been hamstrung by declining federal and private funding. And the IOM said that it saw a network of groups being somewhat stymied by overlapping bureaucracies and duplicative trial efforts.
The IOM found in its research that it now takes 2 years on average to design, approve, and activate a trial. Many of the trials that are undertaken are not completed. Since 2002, funding for the Cooperative Group Program has decreased by 20%. The funding now is lower in inflation-adjusted dollars than it was in 1999, and constitutes less than 3% of NCI’s total budget, according to the IOM.
At the same time, the scientific understanding of cancer has been taking off. But the discoveries – including greater knowledge about the genetic and molecular changes involved in cancer, and wider use of predictive biomarkers during treatment – are a double-edged sword, said the IOM. These discoveries have the ability to "increase the potential impact of trials but also add to their complexity and cost."
Current funding is insufficient to support the number of trials the groups undertake, said the IOM, which urged the NCI to allocate a larger portion of its research portfolio to the Cooperative Groups Program. Acknowledging that this funding might be hard to come by, the IOM alternatively recommended that the cooperative groups should reduce the number of trials being undertaken.
The IOM panel outlined the following four major goals for a revamped clinical trials system:
• Improve the speed and efficiency of the design, launch, and conduct of clinical trials.
• Incorporate innovative science and trial design into cancer clinical trials.
• Improve prioritization, selection, support, and completion of clinical trials.
• Incentivize the participation of patients and physicians in clinical trials.
"The view was, ‘do fewer studies, ask important questions, and get [the studies] done quickly,’ " said Dr. Richard Schilsky, a member of the IOM panel and chief of hematology-oncology at the University of Chicago. He was also chairman of the CALBG until early 2010.