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Oncology Times:
doi: 10.1097/01.COT.0000397187.23704.52
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Cooperative Groups Begin Partnering to Meet NCI Mandate to Pare Down from Nine to Four

Rosenthal, Eric T.

Free Access

In the musical chairs version of consolidating the nine adult cancer cooperative groups into no more than four to meet the National Cancer Institute‘s response to the Institute of Medicine‘s report (OT 5/10/10) recommending reorganization of the current Cooperative Group Program into a National Clinical Trials Network, five groups made two separate announcements about their respective mergers in a three-day period last month.

NCI Cooperative Grou...
NCI Cooperative Grou...
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Then a week later, two more groups eloped.

The American College of Surgeons Oncology Group (ACOSOG), Cancer and Leukemia Group B (CALGB), and the North Central Cancer Treatment Group (NCCTG)—which had already integrated their statistical, data management, and information technology functions last June and had been discussing a full-fledged formal merger for months—released their announcement two days after the Radiation Therapy Oncology Group (RTOG) and the National Surgical Adjuvant Breast and Bowel Project (NSABP) said they would be creating a collaborative alliance.

On March 18, the Eastern Cooperative Oncology Group (ECOG) and the American College of Radiology (ACRIN) Imaging Network said they would merge.

That leaves only the Southwest Oncology Group (SWOG) and the Gynecologic Oncology Group (GOG) left to announce their intentions, since after January 2014 the NCI will no longer support more than four adult cancer cooperative groups.

In practical terms, however, that deadline is actually November 2012, the due date for new grant applications.

The 10th NCI-funded cancer cooperative group, the Children‘s Oncology Group (COG), is exempt from the merger directive because it was voluntarily created in 2000 when the then-four existing pediatric oncology groups became one (OT, 2/25/04) .

The maximum group number of four was recommended by NCI, a number that some interviewed for this article found arbitrary.

“We said up to four, but there is no magic to the number except when we tried to see what would be necessary to meet the scientific opportunities that are available,” Jeffrey S. Abrams, MD, Associate Director of NCI‘s Cancer Therapy Evaluation Program (CTEP), said in a telephone interview.

He used COG as an example of a prior group merger and said that NCI thinks that with nine current adult groups, “we think to have about four would be appropriate, and if it turned out that there were three, that could also work.

“We felt it would leave ample opportunity among the investigators to have new ideas come to the forefront but would enable us to operate the program more as a coordinated network and make changes in the infrastructure more nimbly than if we had the nine different groups.”

Of course, with the peer review process, there is no guarantee that any of the consolidated groups will have a lock on the grants for the new cooperative groups with integrated scientific, operations, governance, and membership functions (U10), or for combined biospecimen and tissue banks (U24).

It is also possible that more than four groups may apply, which is why it makes sense for the groups to work out their merger strategies early on with the most complementary partners so as not to risk standing alone when the last remaining musical chairs are taken.

OT spoke with several of the group chairs involved in the announced mergers about the future of their proposed consolidated groups, but not all responded in time for this article.

Apparently there was a fair amount of outreach by various groups to other groups regarding partnering, with some recognizing their best partners and others initially rejecting consolidation offers.

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Norman Wolmark of NSABP

Norman Wolmark, MD, NSABP Group Chair and Director of Oncology at West Penn Allegheny Health System in Pittsburgh (and a member of OT‘s Editorial Board), said that the RTOG-NSABP had consummated its memorandum of understanding following several months of productive discussions.

“Wally [RTOG Group Chair Walter Curran] and I both discussed this with our separate boards of directors [last year] and negotiations have been ongoing. We‘ve visited each others‘ sites, and have worked together on a major Phase III trial for the last several years [NSABP-B39/RTOG-0413, which is testing breast irradiation for women with early stage breast cancer], and we are developing a joint Phase II breast cancer trial.”

NORMAN WOLMARK, MD, ...
NORMAN WOLMARK, MD, ...
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Walter Curran of RTOG

Walter J. Curran Jr., MD, Executive Director of Emory University‘s Winship Cancer Institute, added that this was “an alliance of peers,” rather than one large group taking over a smaller one.

“Our groups have very complementary agendas with very little overlap or duplication, and we will be stronger together,” he said, noting that RTOG is a world leader for brain, head and neck, and prostate cancers, and that NSABP is a world leader for breast and colorectal cancers.

WALTER J. CURRAN JR....
WALTER J. CURRAN JR....
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Dr. Wolmark said the merger would allow NSABP to broaden its capabilities and add scope to what could be done with novel reagents.

Both group chairs said the structure of the new alliance would be determined by the funding mechanism, but that they thought it important that both entities retain their separate identities. Drs. Wolmark and Curran also alluded that there might be the possibility that other groups could come aboard later.

“We don‘t want to attenuate the culture that has been successful for both our groups,” said Dr. Wolmark, also mentioning the amount of time that cooperative group members volunteer for under-reimbursed work on trials.

“Our identifies and historic legacies are more than necessary to do cancer research on a federal budget,” Dr. Curran said.

They said that they were eventually looking at a structure with two co-principal investigators, as now permitted by NCI, with both distinct and common operations, but that for the time being their respective groups were under defined grants for their operations, tumor banks, and statistical centers, and that the new entity would be created when they could apply for grants together.

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Jan Buckner of NCCTG

Jan Buckner, MD, Professor of Oncology and Chair of the Division of Medical Oncology at the Mayo Clinic, described a different approach for the merger with ACOSOG and CALGB, which is using the working title of “the Alliance.”

He said that in 2006 the statistics and data management centers for NCCTG and ACOSOG began to integrate, and in 2009 when CALGB was recruiting a new group statistician it began exploring the feasibility of sharing those resources.

“We thought it was a good idea because we could leverage the IT and administrative infrastructures, and because all of the cooperative groups have worked collectively to define user needs for a remote data capture system that would serve all the cooperative groups.”

He said that following the awarding of the NCI Cancer Biomedical Informatics Grid (caBIG) contract for a system serving all the cooperative groups, NCCTG was interested in bringing together not only the data and systems management expertise but also the informatics component, and after the IOM report was released in spring 2010 it became logical to look for other ways to bring together the synergies among the three groups since they were already collaborating.

“The scientific expertise, operational expertise, and the memberships of the three groups were complementary, and it would be responsive to the IOM report for us to explore other integrations…especially since neither North Central nor CALGB had any overlapping disease committees, and ACOSOG had its expertise in surgery, NCCTG in community oncology networks, and CALGB in the academic environment.”

He equated the transition to airlines switching different routes and said that transition teams were being formed for vision, mission, and naming; constitution and bylaws; and membership, with the goal being a single membership model.

After the new constitution and bylaws are drafted and ratified by the three groups, a new single chair will be elected to the newly named cooperative group, a process that Dr. Buckner said might be completed later this year.

Looking at the principles of the Alliance, the needs of patients come first, he said. “We are committed to high-quality clinical and translational research, an inclusive environment for contributing scientists and members in our group, and a high-value organization dedicated to quality, safety, and service divided by cost.

“It‘s exciting to take the best part of what you have and create something new,” he said, adding that the Alliance had also thought of adding other partners but hadn‘t gotten very far with other groups.

NCCTG Chair JAN BUCK...
NCCTG Chair JAN BUCK...
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Heidi Nelson of ACOSOG

Heidi Nelson, MD, ACOSOG Group Co-chair and Professor of Surgery in the Division of Colon and Rectal Surgery at Mayo, told OT, “The future is hard to predict with certainty, but on the whole we will all come together and reformulate a new structure and new team rather than as old individual parts.

“We haven‘t yet defined the science, but it will be more powerful and effective, and given ACOSOG‘s small size and limited portfolio, being part of the new group will provide our portfolio with the capacity to grow.

ACOSOG Co-Chair HEID...
ACOSOG Co-Chair HEID...
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“The IOM was clear in its directive, and it seems unusual not to respond in some way.”

Requests for interviews were also made to the chairs of CALGB, ECOG, SWOG, ACRIN, and GOG, but by the time of the deadline for this article the only response came from GOG Group Chair Philip J. DiSaia, MD.

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Robert Comis of ECOG

Although he was not available for comment, ECOG Chair Robert L. Comis, MD, explained in an announcement sent to ECOG participants that a letter of intent was signed to merge ECOG with ACRIN‘s cancer-related scientific programs, which would strengthen his group‘s ability to perform biomarker studies.

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Phililp DiSaia of GOG

In a telephone interview Dr. DiSaia, Professor and Division Director of Gynecologic Oncology in the Department of Obstetrics and Gynecology at the University of California Irvine Medical Center, said, “We don‘t feel that GOG would merge well with any group. Most of those merging have similar menus, but we have a singular menu like COG. We are the only group treating gynecologic cancers. We feel strongly that we can be very effective as a single group,” noting that GOG‘s nearly 5,000 patients on protocols constitute about 20% of all patients on clinical trials.

He said the mainstay of GOG members are the 1,000 gynecologic oncologists in the country who like working together and are interested in volunteering their time for trials and that if GOG lost its autonomy and was merged into another group, its members would lose their enthusiasm and esprit de corps.

“We don‘t want to accept something that is disruptive, that would be insane, and when other groups like ECOG and SWOG tried doing gynecologic oncology trials, they weren‘t able to complete them and we had to finish them.

“We don‘t want a thriving enterprise to suffer from some bureaucratic decision that doesn‘t make much sense. We‘re not asking for more money, although we should get it; all we‘re asking is to leave us alone to do our work. It‘s one thing to take something that is broken and fix it and another to take something that is not broken and try to fix it.”

He said that GOG had issued a white paper making its case. When asked about the future of GOG if it didn‘t merge and wasn‘t able to receive one of the four grants competing on its own, Dr. DiSaia said, “If they deny our grant, they‘ll have to face the public, which will be without studies of GYN cancers, and several politicians I‘ve talked to would be infuriated.”

He also acknowledged that he would be speaking with Drs. Wolmark and Curran in the near future.

When asked about the...
When asked about the...
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When posed with the same question, NCI‘s Dr. Abrams said, “If we had a system that did not include gynecological cancers, that would not be acceptable to the NCI and we would find a way to include trialists who were capable of doing gynecologic cancer. We are not going to have a system that leaves out those tumor types.”

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Institute of Medicine Workshop

The Institute of Medicine held a workshop on March 21 about the revamping of the cancer clinical trials system. As described in an Online First article on Oncology Times.com (http://bit.ly/OT-ClinicalTrials-IOM), a wide range of stakeholders came together to express their ideas on how a new system should be designed.

© 2011 Lippincott Williams & Wilkins, Inc.

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