Teleconference Summary: NCI Clinical Trials Systems
On May 1, 2014, the NCI Office of Advocacy Relations (OAR) hosted a one-hour teleconference with the advocacy community highlighting changes the Institute is making to its clinical trials enterprise. NCI was pleased to have nearly 380 participants join the call to learn more about the new National Clinical Trials Network (NCTN) and the NCI Community Oncology Research Program (NCORP). Dr. James Doroshow, NCI Deputy Director for Clinical and Translational Research; Dr. Jeffrey Abrams, Director for Clinical Research, Division of Cancer Treatment and Diagnosis; Dr. Worta McCaskill-Stevens, Director, NCI Community Oncology Research Program, Division of Cancer Prevention; and Ms. Amy Bulman, Acting Director of OAR, provided updates and answered questions (several of which were sent by advocates before the call) during an open dialogue session. In its role as the conduit between NCI and the cancer advocacy community, OAR will continue to share updates on efforts as they move forward.
A summary of the opening remarks from Drs. Doroshow, Abrams, and McCaskill-Stevens is provided below.
Development of the New Clinical Trials System at NCI (Dr. James Doroshow)
Over the course of several years, NCI has held extensive discussions with stakeholders, including the scientific and advocacy communities and national advisory boards, about ways to improve and modernize the NCI clinical trials systems (e.g., the 2005 NCI Clinical Trials Working Group Report, the 2010 NCI Operational Efficiency Working Group Report, and the 2010 Institute of Medicine Report). Each of these reports, coupled with regular input from our stakeholders, guided the current changes. First, we have tried to think about, with our advocacy and scientific constituencies, how we can do trials more effectively and modify the system to reflect the remarkable changes occurring in oncology, such as our improved understanding of tumor biology and genomics, as well as advancements in molecular pharmacology. NCI’s goal has long been to develop a network of organizations that utilizes cutting edge molecular tools to match patients to the most appropriate trials. Secondly, the system must be able to reach a large number of patients across the U.S. who can be screened for molecular abnormalities to increase patients’ positive response to specific treatment options. This is a major paradigm shift in terms of how we think about doing clinical trials and it requires significant structural changes. Thirdly, NCI must make its clinical trials system as efficient operationally as possible. The new NCTN creates an integrated network to open trials and accrue patients to trials quickly. NCI will have a new system to support clinical trials in the community setting. We are looking at both prevention and treatment, and considering how the practice of oncology is changing and how we should evaluate those changes.
National Clinical Trials Network (NCTN) (Dr. Jeffrey Abrams)
The NCTN is a new program designed to take full advantage of the remarkable changes in oncologic science, including tumor biology, genomics, and molecular pharmacology, and to improve the speed and efficiency of cancer clinical trials. Launched through a new funding mechanism, one of the key differences between NCTN and the previous clinical trial system is the consolidation of ten U.S. clinical trials groups into five integrated groups—four dedicated to adult clinical trials and one group for pediatric cancer research. This new structure contains several new key components that are designed to support all five groups. These new components are intended to improve efficiencies. They include a monitoring and quality assurance core facility named the Imaging and Radiation Oncology Center (IROC). Specific grants have also been given to lead academic participating sites (LAPS), which will serve as scientific leaders in the development and conduct of clinical trials and will also contribute large numbers of patients to NCTN trials. In addition, Integrated Translational Science Awards (ITSAs) will promote integration of translational science into NCTN clinical trials and enable groups to team up with leading scientists to do so.
The overall budget for the entire system is $151 million, which is the same as the funding for the previous years, despite widespread budget cuts across NCI programs. It is important to note that the $151 million does not capture the many other functions that NCI provides in support of the NCTN and the entire clinical trials enterprise. A few of these key centralized functions include the Cancer Trials Support Unit (CTSU), a “one-stop shop” for the group investigators to access all NCTN trials, a Central Institutional Review Board (CIRB) to eliminate the need for local IRB approvals, tumor banking core facilities for each group, and an ancillary studies fund to support biomarker and quality of life research.
In addition, NCI recognized it was going to be a challenge for these long-standing cooperative groups to combine and consolidate, so over the years preceding the NCTN competition we provided transition funds to support the various consolidation efforts of the groups. In terms of closing down active trials, NCI is committed to working with the chairs of each NCTN group to ensure that active trials which are accruing appropriately and meeting endpoints are not closed. The number of new trials opened through this new system depends on how large the proposed trials are and how groups work together to enable more trials to be carried out through this collaborative model. One of the unique features of the NCTN is that it allows trials to be opened across the entire network, so group members of one group can easily enroll patients on trials conducted by any NCTN group.
NCI Community Oncology Research Program (NCORP) (Dr. Worta McCaskill-Stevens)
NCI is in the process of streamlining the Community Clinical Oncology Program/Minority-Based Community Clinical Oncology Program (CCOPs/MB-CCOPs) and the NCI Community Cancer Centers Program (NCCCP) into a single new network titled the NCI Community Oncology Research Program (NCORP).
NCORP will work seamlessly with the NCTN, providing access to cancer prevention and control trials, cancer care delivery, and comparative effectiveness and cancer health disparities research. The program will be comprised of some sites formerly funded through the CCOPs, MB-CCOPs, and NCCCP, as well as new grantee institutions. Funding will continue during the transition and each of the currently funded CCOPs/MB-CCOPs has received instructions for how to obtain funding. Until awards are made, NCI will fund all current CCOPs and MB-CCOPs at their current levels. NCI is committed to ensuring a smooth transition without disruption of patient care; in most cases, a patient will continue their care and follow-up at the same institution or site if the organization has successfully competed for NCORP funds. Sites that do not receive NCORP funding may affiliate with a successful NCORP site and continue participating in NCI-sponsored clinical trials. There is also an opportunity to apply for affiliation directly with one of the NCTN institutions for continued participation in a clinical trial. NCI will work with sites that choose not to affiliate with NCTN groups to find NCORP sites at which patients can receive care and continue on clinical trials. If sites must close, NCI plans to work with sites that will close on a case-by-case basis to determine the resources for those needing treatment and follow-up. The current process is consistent with how NCI has supported the continuation of research in the past. For example, when grant applications have competed for renewal and were not successful, provisions were made for continued care and follow-up at the site or guidance provided for the site to affiliate with other programs to continue participation. Finally, no data from clinical trials conducted through CCOP, MB-CCOP, or NCCCP sites will be lost; all will be incorporated into the NCORP database. More information on NCORP can be found at prevention.cancer.gov/ncorp.