National Cancer Institute-supported clinical trials networks.

Abstract

TO THE EDITOR: The purpose of this letter is to clarify for the community of oncology physicians, other health care providers, patients with cancer, and patient advocates an important issue raised in discussions between leaders of the new, National Cancer Institute (NCI) –supported National Clinical Trials Network (NCTN) and the relevant leaders of the NCI. It was suggested during those discussions that individuals in the oncology community felt that reorganizing the Cooperative Groups was a prelude to reducing the commitment of the NCI to clinical trials– based research. The point to convey from that meeting, held September 23, 2014, is the underlying purpose of the changes NCI has made. Reconfiguration of the Cooperative Group System into the NCTN was undertaken to develop an integrated clinical trials program capable of supporting studies that will modify oncologic practice on the basis of principles of precision medicine. An integrated network is essential to the research goals of the NCI; we have not invested in major changes to this critical infrastructure—including a national central institutional review board; a uniform clinical trials data management system for all research sites; and national systems for accrual, regulatory support, and protocol prioritization— only to gradually eliminate our support for clinical trials research. We have also not re-envisioned our community-based clinical research program (NCI Community Oncology Research Program [NCORP])—with its new mandate to conduct health services research, as well as cancer control and prevention trials—with the intention of discontinuing clinical investigations best pursued at the level of hospital networks and community clinical practices. These changes are not a prelude to further consolidation of the NCI clinical trials infrastructure. To restate what we emphasized when we met, the NCI clinical trials networks are a source of pride to us and are envied by other institutes and centers at the National Institutes of Health. Many of the seminal findings that have advanced the prevention and treatment of cancer are products of our strong cooperative group and community oncology networks. It is our intention only to strengthen those networks through the recently introduced changes. NCI’s investment in modernization of its trials infrastructure has enabled initiation of important studies that use new trial designs and comply with recent regulatory requirements. We believe the Network Groups are now well configured to work as an integrated whole. Incentives are in place to foster creativity and allow competition of ideas, while optimizing enrollment onto those trials selected to go forward. Increasingly, accrual of subsets of tumor types within and across histologies will require screening large numbers of patients with sophisticated diagnostic techniques; this is necessary to identify patients with tumors that harbor molecular alterations that are the focus of a new generation of clinical studies. The four adult groups and single pediatrics group have the capacity to undertake precision medicine trials that rely on the ability of the NCTN and its associated functions to collect tumor tissue, apply highthroughput diagnostics, and enroll appropriately selected patients onto targeted treatment arms. Understandably, concerns have been expressed that budgets for the NCTN are insufficient to support all the trials that could be done. It is true that resource constraints have had an impact on the breadth of trials that the NCTN can conduct. In response, we have developed processes to evaluate trial concepts and prioritize trials that have the greatest promise to answer important scientific questions and change clinical practice in the most beneficial ways. Some fear that the processes required for prioritization will stifle investigator enthusiasm and reduce participation in federally supported clinical trials, but we believe that the opposite is true: new approaches will increase the value of NCI-supported clinical trials, energize the clinical research community, and enhance patient participation. Moreover, NCI’s need to prioritize its research activities extends well beyond clinical research and has affected all of our programs.