With publicly funded correlative science in the nation’s Cancer Cooperative Groups reduced to a trickle, Group leaders propose implementing a long-standing National Academy of Medicine recommendation to bring new money to this area of research through public-private partnerships. They also recommend major process changes to remove significant barriers for researchers to access the biological samples contributed by patients. The current Journal of Clinical Oncology issue features ‘ Correlative Science in the Cooperative Group System—Re-Engineering for Success .’
This Position Paper represents consensus among Evanthia Galanis, MD, DSc for the Alliance for Clinical Trials in Oncology, Janet Dancey, MD for the Canadian Cancer Trials Group, Douglas S. Hawkins, MD for the Children’s Oncology Group, Peter J. O’Dwyer, MD and Mitchell D. Schnall, MD, PhD for the ECOG-ACRIN Cancer Research Group, Norman Wolmark, MD , Robert Mannel, MD , and Quynh-Thu Le, MD for NRG Oncology, and Charles Blanke, MD , for the SWOG Cancer Research Group. The Cooperative Groups and their leaders are integral to the National Cancer Institute (NCI) and the National Clinical Trials Network.
In a statement, the Group Chairs share the rationale for proposing a new approach:
The National Academy of Medicine (NAM, formerly the Institute of Medicine) first recognized the value of correlative science in 2010, recommending “the incorporation of innovative science into cancer clinical trials through the support and use of biorepositories.” A specific recommendation was that the NCI should facilitate “the creation of more public-private partnerships” and “the development of appropriate hybrid funding models, in which NCI and industry support… (would define) …components of trials that are of mutual interest.” Since then, NAM has reiterated these goals on multiple occasions.
In the new publication, the Group Chairs state:
Publicly funded clinical trials conducted by the Cooperative Groups have had a substantial public health impact as measured by life-years saved for people with cancer (Unger JM et al. J Clin Oncol . 2023). The National Institutes of Health (NIH) grants that provide federal resources for these groups to evaluate new cancer treatments also contain goals for studying the biospecimens and tumor samples from trial participants (tumor tissues, normal tissues, certain body fluids, etc.).
Correlative studies for clinical trials explore relationships between molecular biology (biomarkers such as genes and proteins) and clinical outcomes (such as disease progression). They are the promise of precision oncology. Correlative research leads to knowledge beyond the initial trial itself. For example, by studying hundreds or thousands of biospecimens, researchers can uncover which groups of patients do or do not benefit from a particular therapy, identify novel subsets of cancers, or define which patients may be at risk of side effects from treatment.
However, under current rules, investigators encounter enormous difficulties gaining access to biospecimens and tumor tissue for correlative studies. The Group Chairs say that given the rising concerns by stakeholders, it is clear that access to samples needs to be facilitated:
The authors also highlight that the Cooperative Groups are diversifying. For example, programs are underway to increase the efficiency and accuracy of data collection from electronic health records. The Groups are beginning to acquire real-world data outside of clinical trials, to meet the US Food and Drug Administration’s goals for collecting real-world evidence for approved cancer treatments. Also, the Groups are testing artificial intelligence (AI) approaches to interpreting the results of clinical trials, which can greatly extend their value.
The Group Chairs have proposed the legal framework within the paper. The principles of a public-private partnership require that the Cooperative Groups be free to enter into agreements for sample collection and/or disposition with sponsoring entities and have custody of the biological samples. They conclude:
About the Cooperative Groups
The six Cooperative Groups are all part of the National Clinical Trials Network (NCTN). We are groups of researchers, cancer centers, and community doctors who are involved in studies that test new ways to screen, prevent, diagnose, and treat cancer. Clinical trials run by Cooperative Groups are funded and supported by the National Cancer Institute (NCI), and large numbers of patients take part in many locations.
DOI: 10.1200/JCO.24.00527
Journal of Clinical Oncology
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Correlative Science in the Cooperative Group System— Re-Engineering for Success
17-Sep-2024