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Old 03-11-2011, 01:34 PM   #1
Hopeful
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Join Date: Aug 2006
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Research Groups Ally as NCI Clinical Trials Program Begins Seismic Shift

Elsevier Global Medical News. 2011 Mar 10, A Ault

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.

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.

On the “back end” – activities including site audits, data capture, and case reports – it was obvious that there was room for consolidating activities that all the groups have to do and are currently doing in different ways, said Dr. Schilsky in an interview.

But he added that it was the NCI’s conclusion that the groups should consolidate into a smaller number. “That’s a perhaps more extreme position than was articulated by the IOM,” said Dr. Schilsky.

Evolution or Revolution?

The Cooperative Group Program has expanded and contracted since its beginnings in 1955. Soon after the network was established, it quickly became a 17-group entity with a primary focus on testing specific chemotherapy agents. Currently, there are 3,100 institutions (accounting for 140,000 individual investigators) that participate in the nine adult groups and one pediatric group.

The NCI’s expectation is that a sleeker, more efficient, and more patient- and investigator-friendly system will be ready by late 2013. There will be four adult groups and one pediatric group, according to the agency’s plan to implement the IOM recommendations.

But many of the groups saw a need for some sort of change even before the IOM issued the report. The ACOSOG, the CALGB, and the NCCTG had already been talking about combining “back office” functions, said Dr. Buckner. “It seemed like a good scientific and business decision to make,” he said.
The centralization and coordination of statistical and data management began in early 2010 and is now complete, with personnel distributed among the Mayo Clinic, Duke University, the University of Texas M.D. Anderson Cancer Center, and the Ohio State University, said Dr. Buckner.

After the IOM report came out, “it seemed like a very natural progression of events to start talking about further integration of scientific programs and operational capacities of the three groups,” he continued. The three groups have agreed in principle to pursue further integration. But exactly how to do that is another question, he said.

The aim is to seek NCI funding as a single group by autumn 2012. But the goal is to have enough operational efficiencies so that the new organization can devote as much of its funding as possible to the science mission and to recruiting for, conducting, and managing trials, said Dr. Buckner.

He viewed the NCI plan as being a little bit of evolution and a little bit of forced change. Dr. Buckner also noted that the cooperative groups have a huge voluntary element, and that all participants have a common mission and purpose. He thought that the sense of mission would bind the volunteers together in the new system, but noted that those who don’t like the change will have the ability to opt out.

It is just that opt-out potential that worries the RTOG’s Dr. Curran. The groups have been fairly localized with a focused sense of purpose, said Dr. Curran in an interview prior to the merger announcement. “If people don’t feel a personal connection with these enterprises, they may walk away with their precious time and money,” he said.

In addition, he said that mergers can distract organizations from their mission and eat up resources that could otherwise be used for the primary business.
Consolidation was not necessarily needed, said Dr. Curran. The cooperative group system has been shown to be very cost effective in independent studies, he said. And he believes that “the new model is still going to have duplication.”

But the consolidation plan is inevitable, he concluded.

Looking Forward

So what will a new clinical trials system look like? The NCI presented its plan in late November, and called it a “starting point for discussion about consolidation as well as other aspects of transforming the program.”
When all is said and done, the NCI envisions – at the adult level – four operations centers, instead of the current nine; four data management centers, down from the current nine; four disease-specific committees, instead of the current eight; four cooperative group cancer control and prevention research centers, down from the current eight; and three tumor banks, instead of the current nine. Essentially, the groups will become a network of groups with shared responsibilities.

This way, ideas can come from any group or from investigators who are not affiliated with a group. Also, any group will be able to manage a trial. For instance, under the new system, peer review will no longer focus on trials that are proposed by specific disease committees. Instead, the reviewers will take a broader look, assessing how each group can play a role in the broader trial system.

The NCI acknowledged that not everything may go so smoothly at first. There will be some cultural clashes and management issues in the effort to winnow down the groups. And in the short run, harmonizing the groups will likely be expensive.

The agency is in the midst of gathering comments from group members, oncologists, patients, and advocates on how to formulate a new “Funding Opportunity Announcement” for the groups. Essentially, this will be the template that the new groups will have to complete to receive funding under the new system.

By mid-2012, the NCI expects to issue the new application. Awards for 2014 will begin in October 2013. Overall, it is inevitable that both the number of trials and the overall patient accrual will go down, said Dr. Schilsky. To be more efficient, the groups will probably have to conduct fewer studies. But, he said, there may very likely be a “net gain in new information.”

The newly combined ACOSOG/CALGB/NCCTG group will have the same capacity for conducting trials that it did before, said Dr. Buckner. But without additional funding, the overall number of studies conducted will likely decrease, he added.

Dr. Curran agreed that the overall trial picture will largely be guided not by the number of groups, but by the amount of funding available and the number of people still willing to invest their time, money, and energy into the trial enterprise.

Seconding the IOM, he called on NCI to invest more in the groups.
In the end, the cooperative groups need to keep focused on the “right end points,” said Dr. Schilsky. “The goal is not to have lots of trials or lots of accruals, but to get answers,” he said.

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