Program History: The Transition from Cooperative Groups to Network Groups
The Need for a More Responsive, Efficient, and Collaborative System
The recommendations and feedback from the 2010 IOM report and others emphasized the need for a more efficient and streamlined system that can respond more rapidly to scientific opportunities. The IOM report supported earlier NCI initiatives to centralize certain functions common to all trials, such as the regulatory and patient registration tasks performed by the NCI’s Cancer Trials Support Unit and the single ethics review for multicenter trials performed by NCI’s Central Institutional Review Board (CIRB).
The implementation of deadlines for writing and activating clinical trials recommended by the Operational Efficiency Working Group (OEWG)—a working group established by NCI to provide guidance on streamlining the process of developing trials—was also uniformly lauded as a very positive step. Similarly, the introduction of a single electronic data management tool for all Group trials was felt to be essential in fostering greater collaboration among the different groups. The IOM report recommended additional changes, as well. The Cooperative Group Operations and Statistical Centers (referred to in the report as “front and back office operations”) were felt to be overly redundant in their activities, so consolidation into fewer centers was strongly suggested. Hence, NCI undertook a reorganization of the Cooperative Groups.
The program that emerged from this restructuring, the NCTN, has a different focus than its predecessor. Although competition between the individual groups for the best scientific ideas still exists, equal emphasis has been place on teamwork among investigators. Collaboration among the groups is viewed as critical to success at all organizational levels and is now specifically rewarded at the time of grant review. Efficiency is also stressed, and mandatory timelines are now in place for protocol development. Although these changes are viewed as vital for the health of the public system, they also come at an opportune moment, because exciting changes in oncologic science are offering new avenues for rapid advances, particularly for the development of new systemic treatments.
The Previous Structure: Cooperative GroupsNCI’s prior clinical trials system, the Cooperative Group Program, produced many important improvements over more than 50 years. Extensive reviews by expert committees concluded, however, that to more effectively and efficiently complete trials and take advantage of the rapid changes in technology and vastly improved understanding of the underlying biology of cancer, the system had to be restructured. Few major changes were made to the Cooperative Group Program since it was first begun in the 1950s. However, the Institute of Medicine and other expert committees carefully reviewed the Cooperative Group Program and concluded that with 10 decentralized groups (nine adult groups and one pediatric), each with its own operations and statistical centers, tissue banks, and other scientific support services, it needed to become more efficient and collaborative, and restructured to fulfill the promise of precision cancer medicine.
The New Structure: Network Groups
The U.S. groups are each funded through two separate awards—one to support Network Operations and another to support the Statistics and Data Management Centers.
- The Operations Centers are responsible for developing new protocols and managing the regulatory, financial, membership and scientific committees of each group.
- The Statistical Centers are responsible for data management and analysis, manuscript preparation, and safety monitoring, in addition to assisting in trial design and development.
The Network Operations and Statistical Centers for each NCTN group are geographically separate but work closely together. They are often located at an academic institution that has offered to “house” the group; however, in several cases, a Center is located at a freestanding site that is funded via a nonprofit foundation. The only exception to the above is the Canadian Collaborating Clinical Trials Network, which received a single award for its Operations and Statistical Center.
More information about the current Network Groups is available on the main NCTN page.