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Research Groups Ally as NCI Clinical Trials Program Begins Seismic Shift


 

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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