The chairs of the adult clinical trials groups that make up the NCI National Clinical Trials Network said in a letter that recent budget cuts have triggered a “crisis” in clinical research.
Simultaneously, a statement by the president of the American Society of Clinical Oncology, Clifford Hudis, amplified the concerns of the group chairs, and pointed to a separate problem in NCI’s transition to the new structure of clinical research: a three-month gap in funding for community oncology clinics engaged in institute-funded research.
Open criticism of NCI on the part of the institute grantees and ASCO has not been seen in two decades. No such outcry against NCI has been observed since at least 1994, when NCI Director Samuel Broder fired Bernard Fisher from his job as chairman of the National Surgical Adjuvant Breast and Bowel Project (The Cancer Letter, May 13, 1994).
However, the Fisher firing was an isolated event, limited to questions over leadership of a single cooperative group. The controversy now on the table involves the fundamental structure of clinical cancer research in the U.S.
Even when former NCI Director Andrew von Eschenbach pursued his goal to “eliminate suffering and death due to cancer by 2015,” his critics remained silent or worked behind the scenes.
Concern about the three-month funding gap, coupled with implications of patient harm—ASCO alludes to a “dangerous disruption of cancer care”—comes from people who usually keep their rhetoric in check. These protestations amount to a resounding invitation for congressional oversight.
In their April 1 letter to Varmus, the chairs of four newly-formed clinical trials groups said that the trials currently conducted by the groups will consume all available resources.
“We have determined that the execution of our current active trial portfolio alone will consume the proposed funding, and we will have to make decisions that substantially and adversely affect our cancer patients, possibly including, but not limited to closing dedicated disease committees, slowing patient accrual to or closing ongoing studies, and not opening new trials,” the group chairs wrote.
Ending ongoing trials presents ethical problems, the group chairs wrote. “It is a serious ethical dilemma to consider stopping any of these critical trials in progress, to which our researchers have committed and our patients have consented,” they wrote.
The statement by ASCO’s Hudis amplified this message:
“The new National Clinical Trials Network, which replaced the nation’s previous Cooperative Group clinical trials system, faces a 40 percent reduction in operating budgets,” Hudis wrote. “This is forcing NCTN leaders to make an unreasonable choice: either halt critical research studies currently underway—and in the process renege on obligations to patients committed to these studies—or cancel planned and urgently needed new trials. Either choice spells the end, or a significant slowing, of research that could have delivered new treatments and more personalized and effective care to millions of Americans with cancer.”
Hudis also focused on the three-month gap in funding for community-based research.
“National Cancer Institute has made the decision to end funding for federally-funded clinical trials in the community setting through the Community Clinical Oncology Program,” Hudis said in a statement. “As of June 1, 2014, support for the CCOP program will end, jeopardizing care for thousands of patients in communities across the United States—unless and until these research programs receive new NCI research grant funding that is not available until at least September 2014. This will result in a dangerous disruption of cancer care for patients who rely on these trials.”
This criticism comes at a time when NCI stands poised to launch a new generation of clinical trials, some with substantial industry support (The Cancer Letter, Feb. 21).
“We will respond to the group chairs directly,” said Peter Garrett, acting director of the NCI Office of Communications and Public Liaison.
Garrett said the total amount NCI will spend on the groups in the 2014 fiscal year is expected to be roughly the same as it was in 2013: about $150 million. “This is not a 40 percent cut,” he said.
Originally, the groups were expected to get a $25 million increase, to make it possible to increase per-case reimbursement from $2,000 to $4,000 at qualifying sites. However, the money didn’t come through, Garrett said.
Garrett said that operational concessions are required to provide higher reimbursement rates per patient to the academic sites that are developing and performing trials, as recommended by the 2010 IOM report.
He said that these higher rates will be approximately $4,000 per patient for about 50 percent of the patients accrued through the network accrual, compared with approximately $2,000 previously.
The groups should see efficiencies, because many of the functions that were duplicated at cooperative groups have been centralized. Also, NCI has mandated a lower enrollment ceiling to make it possible to increase per-case reimbursement.
“[NCI Community Oncology Research Program] is designed to become an integral component of the overall NCI NCTN,” Garrett said. “It will provide access to studies of cancer control, prevention, screening, treatment, and cancer care delivery in the communities in which individuals live. NCORP will be comprised of some of the sites formerly funded through the CCOPs, MCCOPs, and NCCCP, as well new grantee institutions, in accord with advice received from many sectors during the planning process.
“During the transition to NCORP, we expect to announce most awards before the planned September 2014 date,” Garrett said. “In accord with traditional NCI practice, no patients will be removed from a trial as a result of the reorganization, and accrual into existing studies will continue. The NCI’s long-term goal remains the maintenance of a strong program for community-based clinical research.”
Though the new NCTN officially started to function on March 1, the groups do not yet have their letters of award (The Cancer Letter, Feb. 28).
NCI is adding resources to its national laboratory in Frederick, Md. (The Cancer Letter, Feb. 28). The institute’s spending on intramural research is above the NIH-wide average (The Cancer Letter, March 7).
Recently, NCI and NIH triggered Congressional oversight and appropriations mandates over the level of their spending on public relations activities (The Cancer Letter, Jan. 31).
Once again, the House Committee on Energy and Commerce appears to stand poised to enter the fray.
“The committee is aware of the NCI’s decision to disrupt funding for clinical trials that may jeopardize treatment for thousands of cancer patients,” a committee aide said to The Cancer Letter. “We are monitoring the situation.”
Group Chairs Say Funding Insufficient
The text of the group chairs’ letter to Varmus follows:
Dear Dr. Varmus,
As the Group Chairs of the new National Clinical Trials Network (NCTN) groups, we greatly appreciate your commitment to support efforts that meaningfully improve cancer outcomes. We recognize that the budget allocated to the NCTN by the NCI is relatively stable as compared with the 2012 budget of the legacy cooperative group system, and that this is a better scenario than seen in other NCI-supported research programs. However, the funding structure and allocations across all NCTN initiatives challenge our core network groups’ ability to effectively conduct research, and they are certainly in opposition to many of the direct recommendations made in the 2010 Institute of Medicine report, which prompted the cooperative group restructuring. We are writing in response to the preliminary funding level notices received by our NCTN operations groups and statistical centers on March 1. These funding levels represent a significant reduction from the cooperative group core budgets in 2012 and come after several consecutive years of flat or decreased funding. The proposed funding levels are markedly insufficient to maintain the robust infrastructure necessary for success.
Successful cancer clinical research requires the maintenance of an infrastructure to support required core operations activities. These activities include protocol management, biostatistics and data management, biorepository operations, study auditing, regulatory affairs, institutional member management, training for study personnel, and publications. The creation of the NCTN through mergers of former cooperative groups achieved some efficiencies of scale; however a sufficient level of infrastructure and personnel must be maintained in each of the network groups to initiate, conduct, and complete high quality cancer clinical trials. We have determined that the execution of our current active trial portfolio alone will consume the proposed funding, and we will have to make decisions that substantially and adversely affect our cancer patients, possibly including, but not limited to closing dedicated disease committees, slowing patient accrual to or closing ongoing studies, and not opening new trials.
The NCI-approved portfolio of currently active NCTN trials includes molecularly-driven evaluations of targeted agents, new imaging modalities, and studies directed towards FDA registration being performed in partnership with the NCI and industry. It is a serious ethical dilemma to consider stopping any of these critical trials in progress, to which our researchers have committed and our patients have consented. We also understand the vital importance of activating the new trials that we are developing in partnership with NCI and industry, trials which are vital to deepening our understanding of the relationship between the genomic profile of a given tumor and the likelihood of response and benefit from a defined therapy. Such trials include MATCH, ALCHEMIST, and a host of other exciting approaches previously unavailable to the patients and investigators we serve in academic and community settings.
It is increasingly apparent that the resources currently available to our core operations will not allow our network groups to conduct the type of clinical-translational research that has led to the approval of dozens of new antineoplastic agents. This research has improved the quantity or quality of life for hundreds of thousands of cancer patients, and most important, cannot and will not be carried out by any other academic or private groups. This realization is made following a full review of all the efficiencies that we can enforce in our system and with a full understanding of the serious consequences of choosing any of the options listed above. We are writing to inform you of this crisis and to engage you in this discussion so that together we can seek and identify solutions to this dilemma.
We greatly appreciate your consideration of these issues and would certainly appreciate any other ideas you may have. We will continue to work with our colleagues in CTEP to manage this budget crisis in the most constructive possible way.
Monica Bertagnolli – Alliance
Robert Comis, Mitchell Schnall – ECOG-ACRIN
Cancer Research Group
Norman Wolmark, Philip DiSaia, Walter Curran –
Charles Blanke – SWOG
CC: James Doroshow, Jeffrey Abrams,
ASCO: Treatment Disruptions Will Occur
The text of a statement by ASCO President Hudis follows:
The nation’s clinical trial network, which provides care to thousands of cancer patients across the United States, may have no choice but to abandon life-saving and life-extending research studies, including support for the patients participating in those studies, due to crippling proposed budget cuts. For decades, federally-supported clinical trials have produced critical advances in the fight against cancer, representing one of the greatest returns on research investment anywhere. But this progress could soon grind to a halt due to far-reaching—and largely unnoticed—budgeting decisions that are happening in plain sight.
In the face of its own inadequate budget, which Congress should address, the National Cancer Institute has made the decision to end funding for federally-funded clinical trials in the community setting through the Community Clinical Oncology Program (CCOP). As of June 1, 2014, support for the CCOP program will end, jeopardizing care for thousands of patients in communities across the United States—unless and until these research programs receive new NCI research grant funding that is not available until at least September 2014. This will result in a dangerous disruption of cancer care for patients who rely on these trials. The CCOPs are 60-plus community-based cancer research programs that make participation in clinical trials possible in nearly every community across America. To be very clear, they are being forced to choose between either ceasing research activities or self-funding it.
At the same time, the new National Clinical Trials Network, which replaced the nation’s previous Cooperative Group clinical trials system, faces a 40 percent reduction in operating budgets. This is forcing NCTN leaders to make an unreasonable choice: either halt critical research studies currently underway—and in the process renege on obligations to patients committed to these studies—or cancel planned and urgently needed new trials. Either choice spells the end or a significant slowing of research that could have delivered new treatments and more personalized and effective care to millions of Americans with cancer.
These budget decisions mean that progress will slow. Life-saving therapies will be significantly delayed or not studied at all, local access to state-of-the-art treatments will be reduced, and patients currently receiving study treatments may no longer have expenses reimbursed or could even see their therapy interrupted.
At a time when there are enormous and unprecedented opportunities to improve cancer care, America shouldn’t be turning its back on cancer patients and science. Federally-funded trials have produced some of the biggest advances in cancer care, saving and improving countless lives over the last 50 years. We should not put cancer patients and our scientific leadership in jeopardy by interrupting funding for community-based cancer research.
We urge NCI to restore budgets to CCOPs to prevent the gap in funding to community-based centers and to NCTN operations to prevent this otherwise avoidable damage to our research infrastructure and progress while ensuring that patients with cancer receive critically important, life-extending care, regardless of where they live.