CCOP Letter to Varmus
The letter to Varmus was signed by 56 of the 64 CCOP PIs.
The text of the CCOP letter to Varmus follows:
Dear Dr. Varmus,
The current CCOP grant recipients were informed in a letter dated 3/6/14 from Crystal Wolfrey, Chief of the Office of Grants Administration, and in a follow-up phone call with Sean Hines and Worta McCaskill-Stevens on Monday 3/26 that there would be essentially no bridge funding from 6/1/14, when the current CCOP grant terminates, to September 2014, when the NCORP grants would be funded.
This funding gap presents major challenges to the community sites that are participating in the CCOP program in fulfilling their obligations under the current grant. We are curious where the allocated funds for the CCOP program were re-directed, given the fact that the majority of CCOP’s had ongoing funding commitments for this period.
On the CCOP conference call, we were advised that some CCOP’s have “restricted funds” available. Access to restricted funds helps only a minority of the CCOPs. For those CCOPs that do have potential access to restricted funds, the funds available are inadequate to support clinical operations for a 3 month period. There are thousands of patients on trials that require close monitoring. In addition we have an obligation to continue to accrue new patients so they can have uninterrupted access to these potentially life-saving treatments.
The CCOP sites simply cannot afford to treat patients on NCI sponsored trials with limited or no funds. We will not have access to institutional funds during this funding hiatus as hospital budgets have long since been approved. As was the case during the federal “sequester period” staff may have to be furloughed at CCOP institutions.
This situation raises significant safety concerns in regards to patient toxicity monitoring and data submission to respective study bases. We have a legal, ethical and moral obligation to our patients to provide a safe environment for patients receiving investigational and life-preserving cancer treatments. This obligation will be severely hampered if there is no gap funding.
With this in mind, we respectfully request the following:
- Access to funds previously earmarked to CCOPs to bridge the funding gap (We were informed that all grant award notices are being amended to remove the funding previously awarded for 6/1/14 to 5/31/15).
- The CCOP funding should be equivalent to previously awarded amount .
- No restrictions on new accruals during this transition.
- If delays in the NCORP roll-out occur, appropriate and adequate funding should be provided to cover the entire gap period.
- For those CCOPS who are not awarded an NCORP grant, close-out funds should be available to continue to monitor and report on patients who are actively being treated on study and follow-ups.
June 1st is rapidly approaching and obviously CCOP’s will need to make decisions based on this funding issue, including potentially stopping accrual now to reduce the staffing necessary to run operations during the program transition.
The CCOP programs and their patients have been significant contributors to the NCI Clinical Trials efforts for almost 30 years and an important part of the NCTN going forward but we cannot fulfill our obligation to patients and the research enterprise without consistent and adequate funding. We request prompt attention to these concerns.
Sincerely,
CCOP PIs
CC: Worta McCaskill-Stevens, MD, MS
James Doroshow, MD
Jeffrey Abrams, MD
Varmus Responds:
Dear Colleagues,
As you are aware, the National Cancer Institute (NCI) is in the process of combining its two community-based research networks to create a single network that builds on the strengths of the Community Clinical Oncology Program/Minority-Based Community Clinical Oncology Program (CCOPs) and the NCI Community Cancer Centers Program (NCCCP).
This network, the NCI Community Oncology Research Program (NCORP), will support a wide range of clinical research, including treatment-focused as well as cancer prevention and control–based clinical trials; population-based studies; and behavioral, health services, and outcomes research.
It will encompass community-based cancer specialty organizations in the same manner as have the CCOPs and NCCCP, and will work closely with the National Clinical Trials Network (NCTN).
The transition to any new large clinical research structure is never easy either for the agency administering it or for those people and institutions applying to participate in it. The creation of the NCORP is no exception.
Some of the difficulties are easily mitigated but others require greater efforts to ensure that the fundamental principles and values of clinical research are upheld. NCI remains fully committed to these principles, most especially our obligation to patients.
Current NCI grantees conducting community-based clinical research have voiced concerns about the maintenance of funding between the end of the current round of annual CCOP awards (June 1, 2014) and the start of the NCORP (now estimated to be August 1, 2014).
With Fiscal Year 2014 budgets now in place, our grantees can be assured that NCI will fund all CCOPs at their current levels during this period. While this was always our intention, this has not been clearly communicated.
Furthermore, currently funded investigators should continue the active, uninterrupted accrual of patients to new or ongoing clinical trials during this interval. As in the past, full funding for all research activities required to carry out approved studies will be provided.
Those CCOP/MB-CCOP institutions that successfully compete to become NCORP members should have a seamless stream of funding as the new consortium structure commences.
NCI will work with sites that either do not successfully compete for an NCORP award or choose not to transition into the new network. NCI will make funds available, as necessary, to assist these sites to implement their affiliation with another site or to carry out the process of closing their NCI-supported activities.
For those sites, decisions will be made on a case-by-case basis, in accord with factors such as accrual rates and number of patients in follow up. NCI remains committed to every patient enrolled in a clinical trial and will ensure that they continue to have the opportunity to receive the full benefit of those trials.
The CCOPs and MB-CCOPs, including their dedicated physicians and staff, have played an essential role in the national clinical trials enterprise. An effective transition into NCORP, along with the continued care of patients, will be an important measure of the new network’s success.
We must work together to adapt swiftly and effectively to achieve the goals of the new system—namely, to take advantage of recent advances in our understanding of cancer and to bring new knowledge into clinical trials conducted in the community. Our patients deserve nothing less.
– Harold Varmus
