The National Academy of Medicine (NAM) first recognized the value of correlative science in 2010, recommending that innovative science be incorporated into cancer clinical trials through the support and use of biorepositories. A specific recommendation was that the National Cancer Institute (NCI) should facilitate the creation of more public-private partnerships and the development of appropriate hybrid funding models for NCI and industry support. 

Since then, NAM has reiterated these goals on multiple occasions. However, they were never implemented. 

Now, with publicly funded correlative science in the nation’s Cancer Cooperative Groups reduced to a trickle, Group leaders propose implementing the long-standing NAM 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 Journal of Clinical Oncology has published the Group Chairs’ proposal, ‘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 Network. The Cooperative Groups and their leaders are integral to the NCI’s National Clinical Trials Network (NCTN).

In a statement, the Group Chairs share the rationale for proposing a new approach:

“The Cooperative Group Chairs have observed the risk and reality of underfunding for correlative science, which has resulted in unused patient samples accumulating in our tissue banks. Unused samples have an opportunity cost in losing the full value of these independent trials, and we fail our patients by not extracting the maximum information from the valuable samples they provide. The focus of this Position Paper is to reorder processes at multiple levels so as to bring new funding into a dynamic and real-time correlative science program.”

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 subgroups may be at a worse risk of experiencing side effects from treatment.

However, under current rules, investigators encounter enormous difficulties accessing 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:

“Correlative research on Group tissue samples is almost at a standstill because of these barriers to access. Not alone does this represent an opportunity cost; the barriers are a disincentive to the participation of early- and mid-career translational and basic scientists whose expertise and engagement the system needs the most, and so there is a future loss to science and careers in cancer research.”

The principles of a public-private partnership would 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.

“There is an opportunity to achieve two major goals with this proposal. The first is to create structures that will facilitate translational research alongside the clinical trials with an impact that can reach far into the future. The current system, though well intentioned, has been rendered nonfunctional, weighed down by barriers to getting the research done by the people most capable of doing it. The second is that in common with other research organizations, the Cooperative Groups are diversifying in ways that recognize and leverage the data-rich and rapidly changing information ecosystem in order to create the benefits that a learning environment can bring to tailoring individual treatment plans for patients.”

Related:

Guest editorial in The Cancer Letter (requires subscription)