Practice Update
News and views on issues related to improving the quality of hematologic care .
The Evolution of the National Cancer Institute ’ s National Clinical Trials Network
● JUST OVER 10 YEARS ago , the National Cancer Institute ( NCI ) shook up the hematology / oncology clinical trial landscape by reorganizing its various cooperative research groups to form a new entity called the National Clinical Trials Network ( NCTN ).
The NCTN brings together academic centers , clinicians , and community hospitals and medical centers to coordinate and support cancer clinical trials at more than 2,200 sites in the U . S ., Canada , and select locations around the globe . 1
The reorganization effort sought to streamline the research infrastructure and foster greater efficiency and coordination . Part of that effort meant downsizing the more than 50-year-old NCI Clinical Trials Cooperative Group Program from nine groups conducting trials in adult patients to just four adult groups , plus one pediatric research group , and the Canadian Cancer Trials Group . 2 The reorganization merged existing groups to create four new entities : the Alliance for Clinical Trials in Oncology , the ECOG-ACRIN Cancer Research Group , NRG Oncology , and the SWOG Cancer Research Network . The Children ’ s Oncology Group , a key part of the NCTN , had been consolidated previously .
Now , a decade later , leaders in the NCTN say they have accomplished many of their goals and have the practice-changing cancer research to show for it , such as the TAILORx trial that showed that some women with breast cancer could safely skip chemotherapy . However , other stakeholders and researchers say it is time for another critical look at the NCTN ’ s structure to ensure it continues to achieve its goals of facilitating innovative research and reining in bureaucracy .
IOM Report Lays a Foundation for NCTN While the NCI Clinical Trials Cooperative Group Program had notched many significant successes in its more than 50-year history , by 2010 the average time needed to design and launch a trial was two years . Many trials were launched but never completed . The program was also suffering from dwindling federal funding . As a result , the NCI director asked the Institute of Medicine ( IOM ) to evaluate the program and recommend improvements . 3 That report , titled “ A National Cancer Clinical Trials System for the 21st Century : Reinvigorating the NCI Cooperative Group Program ,” launched a complete restructuring , according to Richard F . Little , MD , head of Hematologic , HIV , and Stem Cell Therapeutics at the NCI ’ s Cancer Therapy Evaluation Program .
“ The IOM report recommended the prior adult NCI Cooperative Groups be consolidated into a network structure with a smaller number of groups ,” Dr . Little told ASH Clinical News . “ The goal was to better leverage the centralized infrastructure to take advantage of scientific opportunities with rapidly evolving science .”
In the April 2010 report , IOM praised the decades of work done by the Clinical Trials Cooperative Group Program in advancing knowledge of cancer prevention and reducing use of toxic therapies , with the qualification that the structure meant it could not keep pace with new advances related to the genetic and molecular drivers of cancer .
“ One major problem is the complex system of designing , reviewing , and initiating Cooperative Group clinical trials , which has become a lengthy and redundant process typically requiring years to complete ,” the committee wrote in the report . “ In attempting to optimize the effectiveness and safety of trials , proposals often are redrafted and recycled by multiple stakeholders from academic institutions , federal agencies , institutional review boards , and industry . This results in frustration and a perception that stakeholders are working at cross-purposes .”
The 300-page report included 12 recommendations for “ reinvigorating ” the NCI ’ s research program , such as consolidating many of the functions of the Cooperative Group scientific committees and statistical offices , as well as the administrative structures focused on data collection and management . The committee also called for streamlining and harmonizing government oversight and reevaluating the role of the NCI in the clinical trials system . Additional recommendations were aimed at increasing the speed of clinical trials , funding for the research programs , and collaboration among all participants in the research infrastructure .
Cancer Clinical Trials : Then and Now Just a few months after the IOM committee issued its report , the NCI announced the consolidation of its research groups and the centralization of many of its administrative functions .
The move ’ s purpose was twofold , according to a 2020 review from the leaders of the individual NCTN research groups . By consolidating the groups , the NCI could achieve the efficiencies and reforms recommended in the IOM report . It could also save money at a time when the U . S . was enduring a period of economic recession . 4 Under the reorganization :
• The American College of Surgeons Clinical Oncology Group , the Cancer and Leukemia Group B ( CALGB ), and the North Central Cancer Treatment Group merged into a single new group that became the Alliance for Clinical Trials in Oncology .
• The Eastern Cooperative Oncology Group ( ECOG ) merged with the American College of Radiology Imaging Network ( ACRIN ) to form the ECOG-ACRIN Cancer Research Group .
• The National Surgical Adjuvant Breast and Bowel Project , the Radiation Therapy Oncology Group , and the Gynecologic Oncology Group were folded into the NRG Oncology group .
• The Southwest Oncology Group ( SWOG ) was the only cooperative group that stayed intact , but it was eventually renamed the SWOG Cancer Research Network .
• The Children ’ s Oncology Group was the result of the merger of four cooperative pediatric research groups in 2000 .
The NCTN ’ s structure also includes the Canadian Cancer Trials Group , which works with the U . S . groups on late-phase , multi-site clinical trials .
“ The network structure enables studies to be conducted across all ages and diseases . The structure particularly enables precision medicine and umbrellatype trials , a key point in the 2010 IOM report ,” Dr . Little said .
The NCTN has a spoke-and-wheel structure with several NCTN centralized functions at the center , surrounded by the five U . S . research groups , each of which maintains its own operations , statistics and data management , tissue banks , and member sites . The 32 lead academic sites that are part of the NCTN participate across the four adult research groups in the U . S . ( See the FIGURE for an illustration of this structure .)
As part of the reorganization , the NCI centralized several administrative functions that the IOM report identified as redundant when housed in the individual research groups . The NCTN ’ s centralized functions include a single Institutional Review Board , Cancer Trials Support Unit , Imaging and Radiation Oncology Core Group , and a common data management system .
Each of the research groups maintains its own tissue bank but follows NCTN ’ s standard protocol for tissue collection . Each group must maintain electronic records for the tissue samples that provide information on the treatment the patient received , his or her response , and outcome . If patients consent , their tissue samples may be used in other NCTN studies beyond the trial in which they originally enrolled . 1
Data management was also upgraded during the reorganization , with all groups adopting a common
12 ASH Clinical News November 2021