New National Clinical Trials Network Faces Challenges Budget cuts and enrollment caps have group leaders concerned

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fter several years of consultation and development, the National Cancer Institute (NCI) launched its newly formed cooperative group system for clinical trials research, the National Clinical Trials Network (NCTN), on March 1, 2014. The new network was developed based on recommended changes from a 2010 Institute of Medicine report, along with input from cooperative group investigators; NCI comprehensive cancer center directors; and others, including patient advocates and industry representatives. The overall goal of the new system is to improve the speed and efficiency of clinical trials and to be able to respond more rapidly to scientific opportunities. “The new network represents an unmatched effort to integrate and streamline the process of cancer clinical trials research,” says James Doroshow, MD, deputy director for clinical and translational research at the NCI. “The NCTN replaces a structure that was more than 55 years old.” One of the main changes was to consolidate the former 9 decentralized cooperative groups into 4 adult groups with more centralized operational functions. Similar to the old system, another large group is focused solely on childhood cancers. The 4 adult groups are NRG Oncology, the Alliance for Clinical Trials in Oncology, Eastern Cooperative Oncology Group

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(ECOG), American College of Radiology Imaging Network (ACRIN), and Southwest Oncology Group (SWOG) (which did not merge with any other another group). In addition, 30 US academic institutions are being funded as Lead Academic Participating Sites (LAPS). Most LAPS are NCI-designated cancer centers that were required to demonstrate their ability to enroll high numbers of patients into NCTN trials as well as scientific leadership in the design and conduct of clinical trials. “Major aims of the new network are to promote collaboration among investigators to provide trial sites with the ability to participate in the trials regardless of which groups within the network lead the study,” says Meg Mooney, MD, MBA, chief of the NCI Clinical Investigations Branch. “We also have a much more systematic way to monitor protocol development and timelines, have developed operational efficiency guidelines, and have centralized administrative and regulatory functions.” Key centralized functions of NCTN include a common data management system, a central Institutional Review Board, a cancer trials support unit, and an imaging and radiation oncology core group. As clinical trials increasingly move toward testing agents that target specific molecular pathways in tumors, large numbers of patients will need to be screened to identify such subsets, Dr. Mooney adds. She notes that the new network structure will enable investigators to better conduct trials that require this type of large initial screening. “We’ve been working on the transition for about 2 years, and the leadership is quite excited about the way our research can make a difference,” says Walter Curran Jr, MD, cochair of NRG Oncology, which is a merger of the former Radiation Therapy Oncology Group, the National Surgical Adjuvant Breast and Bowel Project, and the Gynecologic Oncology Group. “We’ve taken some of the resources from our legacy groups and brought them together to do better work. Never has there been such a large aggregate of investigators in one group.”

Fiscal and Enrollment Challenges Although Dr. Curran and leaders of the other NCTN cooperative groups applaud the efforts to make the system more efficient, they also express serious concerns about their budgets being cut and about a new cap on annual enrollment of patients onto clinical trials. “It’s a wonderful network with phenomenal capabilities, but it’s like we have a brand new vehicle that’s all shiny and new and ready to go, and we don’t have much gas to put in it,” says Monica Bertagnolli, MD, chair of the Alliance for Clinical Trials in Oncology group. “It’s very demoralizing to work so hard to build it and then not be able to use it the way we’d hoped.” 2223 1

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The Alliance’s total budget was cut by 25%, according to data provided by Dr. Bertagnolli. At the same time, the NCI has placed a cap on patient enrollment of 17,000 per year across the system, which includes 12,000 for adults. “At our peak, we treated 29,000 patients per year,” Dr. Bertagnolli says. “This year, the Alliance will probably do 35 to 40 trials, when we used to have between 65 and 80.” Leaders for ECOG-ACRIN voiced similar concerns. “The cuts have led to the loss of several million dollars in support of our laboratory programs, researchers, and institutions,” say ECOG-ACRIN cochairs Robert Comis, MD, and Mitchell Schnall, MD, PhD. “More than 20 FTEs [full-time employees] were released from our operations and biostatistical centers. Lost were experienced research personnel across therapeutic and diagnostic imaging disciplines that had already been deemed essential following our merger in 2012.”

It’s a wonderful network with phenomenal capabilities, but it’s like we have a brand new vehicle that’s all shiny and new and ready to go, and we don’t have much gas to put in it. — Monica Bertagnolli, MD Dr. Curran adds, “The initial vision to make this system succeed was that there would be an addition of $25 million allocated to the overall system for operations and statistical data management centers. Assuming that an appropriate portion of that went to the groups, that would have made a difference.” According to budget figures released by the NCI, the overall NCTN budget for the program is $151 million, which is the same total budget provided to the cooperative groups in the fiscal years 2012 and 2013, despite substantial reductions in the NCI budget resulting from sequestration starting in 2013. However, the distribution of funds to the network group operations centers changed from 62% in 2013 to 47% in fiscal year 2014 due to the consolidation of operations and statistical centers as well as funding of new components of the NCTN, which include the LAPS as well as new integrated translational science awards, according to the NCI. LAPS will now receive 16% of the reallocated budget, whereas the new translational science awards constitute 3%. In a statement on their Web site, the NCI adds that, although the number of patient accruals per year is being reduced by 15%, the reduction will occur gradually over 2 to

3 years. They note that they have reserved funds to distribute to the NCTN groups later this fiscal year to accommodate an enrollment of approximately 21,000 patients. “NCI believes that reducing the budget of the network group operations centers will not impede NCTN’s ability to perform important trials,” the statement notes. “For example, future clinical trials will, in many cases, require fewer numbers of patients due to the selection of patients most likely to benefit from the intervention being tested.” An NCI spokesperson also said that it is difficult to compare the groups’ new budgets with previous ones under the former cooperative group system. “There is not a direct equivalence, as there were 9 groups and now there are 5, so just tallying based on former group status alone would not be very representative, especially considering that NCI has provided significant additional annual support for the cooperative groups and will continue to provide these funds for the NCTN, in addition to the grant funding,” she says. “Clinical trials are complex undertakings that require a host of support organizations and funding streams. The new system includes a number of other features that are not included in the NCTN awards but that are essential to carrying out the NCTN mission.” Nevertheless, Dr. Bertagnolli and her fellow NCTN leaders are worried about the long-term impact of the enrollment caps and changes to their overall budgets. “We have to make some tough choices because we’re not used to being downsized so significantly,” she says. “There are many important advances in the care of cancer patients that will not be realized because we can’t do the research.” Research in areas such as rare tumors, ways to improve high health care costs, and the evaluation of new drugs in combination with surgery and radiation is likely to be impacted, she says. Drs. Bertagnolli and Curran also point out that fewer large phase 3 trials will be conducted as a result of the cuts because these studies require many more patients. Instead, they say, the emphasis will likely be on smaller phase 2 trials. With the amount of research being reduced, younger generations will be less likely to enter the field, whereas scientific teams that have been created within the networks will be difficult to keep together, Dr. Bertagnolli adds. “Unless they have work to do, these teams will disappear, and you can’t create them overnight,” she says. “We are going to lose some of our brain trust.” DOI: 10.1002/cncr.28886

New Findings in Colon Cancer Incidence, Screening

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wo recent colon cancer studies reported findings on incidence rates and a new noninvasive screening tool. In the first study, researchers found that colon cancer incidence rates have dropped 30% in the United States in the last 10 years among adults aged 50 years and older due to the widespread use of colonoscopy.1 Published in CA: A Cancer 2224

Journal for Clinicians, the report found the largest decrease in incidence in people aged older than 65 years. At the same time, colonoscopy use has tripled among adults aged 50 to 75 years, from 19% in 2000 to 55% in 2010. The article was released by American Cancer Society researchers as part of an initiative by the National Colorectal

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New national clinical trials network faces challenges: budget cuts and enrollment caps have group leaders concerned.

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