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Mar 28, 2011
 |  BioCentury  |  Product Development

Structure vs. function at NCI

NCI clinical coops realigning, but no consensus on future of cancer network

Now that the Eastern Cooperative Oncology Group and the American College of Radiology Imaging Network have decided to merge, NCI is down to five adult cooperative groups.

But even though the first round of mergers and alliances instigated by NCI have taken place relatively quickly, discussion at an Institute of Medicine/ASCO workshop last week indicates these agreements should not be interpreted as a consensus about how the clinical trials system should be restructured.

NCI has said it intends to fund just four adult cooperative groups, but the last two unpaired groups each want to remain independent. In addition, it is far from clear how the groups that have agreed to combine intend to structure themselves, and how much latitude they will be given by NCI to develop organizations and set priorities that allow their investigators to answer the kinds of clinical questions that interest them.

The workshop brought together the leadership of the existing cooperatives - nine focused on adult cancers and one on pediatric cancers - along with officials from NCI and FDA, and representatives from industry, community hospitals and advocacy groups.

The topic was implementing IOM's recommendations for overhauling the national clinical trials system, of which NCI's Clinical Trials Cooperative Groups program is one component.

As part of that overhaul, NCI announced in December it intended to consolidate the nine adult groups into four multi-disease, multi-disciplinary groups, while leaving the Children's Oncology Group (COG) in its present form (see BioCentury, Feb. 28).

The goal is to conserve resources and reduce duplicated effort, and to improve systemwide prioritization of the trial concepts that get funded.

While stakeholders at the workshop agreed that increased collaboration is good for the system as a whole, they raised concerns that imposing centralized decision-making on the co-ops will squelch innovation and drive talented investigators away.

Participants also questioned whether NCI and IOM have been too focused on arriving at a magic number of cooperative groups instead of letting scientific strategy dictate infrastructure.

Model merger

IOM and NCI have put forth the Children's Oncology Group as the model for consolidating the adult groups. In a presentation to the workshop, former COG Chair Greg Reaman described how the organization was created in 2000 through the merger of four smaller pediatric oncology groups.

The process involved not only creating a single operations center with a new data system, but also adopting a new constitution and new membership criteria.

So far, only one of the announced combinations of adult groups definitively fits that mold. The American College of Surgeons Oncology Group (ACOSOG), the North Central Cancer Treatment Group (NCCTG) and Cancer and Leukemia Group B (CALGB) have said they will create a new group with a single scientific agenda, constitution and bylaws, and membership model.

The American College of Radiation Imaging Network (ACRIN) and the Eastern Cooperative Oncology Group (ECOG), the most recent groups to announce their engagement, are still working out their new structure. But the idea behind the...

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