EDUCATION electronic format . The NCI implemented study development timelines , and studies that did not meet deadlines , were not activated . 4
The various groups coordinate and share resources in other ways , too , according to Dr . Little . For example , in research groups ’ investigational new drug studies that are sponsored by the NCI ’ s Cancer Therapy Evaluation Program , the NCI Division of Cancer Treatment and Diagnosis handles drug distribution and regulatory issues . In addition , national disease-specific steering committees ensure the clinical trials are prioritized in a coordinated way among the groups . The Cancer Trials Support Unit facilitates centralized 24 / 7 enrollment of patients and enables sites to participate in any active NCTN study regardless of group affiliation .
The research groups also coordinate the codevelopment of individual trials and setting research priorities in specific diseases , according to Peter J . O ’ Dwyer , MD , and Mitchell D . Schnall , MD , PhD , co-chairs of the ECOG-ACRIN Cancer Research Group .
Taking acute myeloid leukemia research as an example , “ the three groups with leukemia committees have agreed to focus on evaluating the therapies in distinct molecular subsets of the disease ,” Drs . O ’ Dwyer and Schnall explained . “ Shared access to biospecimens and imaging technologies helps advance our understanding of response and resistance and ultimately drives toward a precision medicine approach to every patient .”
Outside of the NCTN structure , each of the five U . S . research groups has an associated research foundation that assists with running clinical trials that the groups consider “ promising ” but are not part of an NCI-funded research program . These trials cover a diverse range of topics , from industry-funded trials of new therapeutics to research into health services delivery funded through the Patient-Centered Outcomes Research Institute . Regardless of the study sponsor , the foundations provide independent oversight through their scientific steering committees . 4
Measuring Success and Looking to the Future Over the years , the NCTN has amassed a long list of success stories . That success has been measured through the evaluation of its clinical portfolio ’ s impact on practice , reductions in time from study proposal to activation and completion , and increases in patient accrual to studies across the entire network , according to Dr . Little . Progress has also been demonstrated through greater resource allocation for biomarker , imaging , and quality of life studies .
At the 2021 European Society for Medical Oncology ( ESMO ) Congress in September , SWOG leaders shared findings from an analysis looking at how NCTN ’ s publicly funded cancer research has affected the landscape of cancer care . 5 They reviewed all randomized phase III trials from the four U . S . adult NCTN groups reported from 1980 to 2019 and identified studies that had statistically significant findings for at least one clinical , time-dependent outcome . Of the 163 trials selected , 128 showed a positive overall survival finding favoring the experimental arm . Researchers estimated that , overall , these trials generated gains of 14 million life-years for patients with cancer . Research into how these trials influenced cost and clinical care guidelines is still ongoing , they added .
In addition , since the reorganization of the cooperative groups , the NCTN research groups have launched several studies that seek to establish new standards of care , set the stage for approval of new therapies by the U . S . Food and Drug Administration , evaluate new treatment approaches , and validate biomarkers . For instance , the NCI- MATCH and NCI-COG Pediatric MATCH trials are large-scale precision medicine studies in which cancer patients are assigned to treatment based on genomic sequencing and other molecular testing of their tumors . These trials are among the first to match patients with cancer to specific treatments based on their genetic tumor changes rather than their cancer type – demonstrating Source : Cancer . gov . the potential benefits of using genomic sequencing to guide treatment . These two trials have also set the stage for the next round of precision medicine trials , such as Combo-MATCH to address combination regimens , iMATCH to evaluate immunotherapy regimens , and MyeloMATCH for leukemia trials . 4 , 6 , 7
Drs . O ’ Dwyer and Schnall also noted that the NCTN ’ s success could be measured by the number of trials it has launched that would not have been mounted by industry . “ Being free of industry ’ s strict focus on the market and shareholder value allows us to concentrate on patient benefit ,” they said . “ The most common examples are studies in indications not on a company ’ s development path . However , the groups are also well known for piloting combination regimens not previously considered and accelerating the development of therapies into the adjuvant space .”
Despite the progress under the current structure , there is support for reevaluating the NCTN in light of new challenges in cancer research , according to Monica M . Bertagnolli , MD , of Brigham and Women ’ s Hospital . Dr . Bertagnolli currently chairs the Alliance for Clinical Trials in Oncology .
“ Unfortunately , clinical trials are more complex than ever , and this means that the operational infrastructure , including study review and approval processes , are as challenging or maybe even more challenging now than they were at the time of the IOM report ,” she said . “ I think that it would be an excellent idea to take another in-depth look at the structure and functions of the NCTN .”
Drs . O ’ Dwyer and Schnall echoed her concerns about the ongoing challenges in conducting cancer research today , including rising costs , the reluctance of companies to provide their new agents for trials off their registration path , and a burdensome regulatory environment . They noted that the NCTN group chairs have initiated a dialogue with the NCI about measuring progress over the last 10 years and assessing areas for improvement .
Richard Schilsky , MD , who chaired the Cancer and Leukemia Group B before the reorganization and served on the IOM committee that authored the 2010 report , said the NTCN could have a greater impact on cancer advances if it eliminated some of the bureaucracy embedded in the system .
For instance , one of the 12 IOM recommendations that has not been implemented called on NCI staff to convene , but not participate in , the scientific review of trials conducted by the group steering committees . Today , NCI staff continue to be involved in those
FIGURE . NCI National Clinical Trials Network Structure
discussions , resulting in a less independent scientific review process , he said . Another IOM recommendation proposed that the FDA lead the scientific review of study protocols that involve an investigational new drug . 8 In practice , both the NCI and FDA are involved in the protocol review , which can create an iterative and circuitous process , Dr . Schilsky noted . Those two changes could go a long way to “ improving the quality of peer review and reducing the bureaucracy ,” he said .
Dr . Schilsky also called on NCTN to reexamine its goals going forward . For example , today ’ s hematology / oncology practitioners have multiple therapeutic options available to them , but have no clear guidance on how to select the best treatment for an individual patient . That type of comparative-effectiveness research would deliver value to patients , he said .
“ There is no other country on earth that has a publicly funded clinical trial system like the United States has for cancer ,” Dr . Schilsky said . “ Even within the U . S ., most of the non-cancer medical specialties envy what we have available . So , we better be sure we ’ re making the best use of it . I think the time has come to take another look at how those resources are being best spent .” — By Mary Ellen Schneider
References 1 . National Cancer Institute . NCTN : NCI ’ s National Clinical Trials Network . Accessed
October 13 , 2021 . https :// www . cancer . gov / research / infrastructure / clinical-trials / nctn .
2 . National Cancer Institute . NCI announces plans to reinvigorate clinical trials . December 23 , 2010 . Accessed October 13 , 2021 . https :// www . nih . gov / news-events / news-releases / nci-announces-plans-reinvigorate-clinical-trials .
3 . Institute of Medicine ( US ) Committee on Cancer Clinical Trials and the NCI Cooperative Group Program . A National Cancer Clinical Trials System for the 21st Century : Reinvigorating the NCI Cooperative Group Program . Washington , DC : The National Academies Press .
4 . Bertagnolli MM , Blanke CD , Curran WJ , et al . What happened to the US cancer cooperative groups ? A status update ten years after the Institute of Medicine report . Cancer . 2020 ; 126 ( 23 ): 5022-5029 .
5 . Unger JM , LeBlanc M , Bertagnolli M , et al . Clinical and scientific impact of National Cancer Institute : Sponsored clinical trial network group treatment trials . Ann Oncol . 2021 ; 32 ( suppl _ 5 ): S1102-S1110 .
6 . National Cancer Institute . NCI-MATCH Trial ( Molecular Analysis for Therapy Choice ). Accessed October 13 , 2021 . https :// www . cancer . gov / about-cancer / treatment / clinicaltrials / nci-supported / nci-match .
7 . National Cancer Institute . NCI-COG Pediatric MATCH . Accessed October 13 , 2021 . https :// www . cancer . gov / about-cancer / treatment / clinical-trials / nci-supported / pediatricmatch .
8 . Schilsky RL . The National Clinical Trials Network and the cooperative groups : The road not taken . Cancer . 2020 ; 126 ( 23 ): 5008-5013 .
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