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.