By Alicia Ault
Elsevier Global Medical News
Breaking News
April 15, 2010 11:34 AM EDT
Saying that the cancer clinical trials system is in a state of crisis, an expert panel of the Institute of Medicine (IOM) called for an overhaul to speed up trial design and execution, incorporate scientific discoveries more rapidly, and create a structure to reimburse physicians and cover patients’ costs for participation in studies.
In a report issued Apr. 15, the 17-member panel said the backbone of the system, the National Cancer Institute-supported Clinical Trials Cooperative Group Program, has become cumbersome and inefficient. According to the report, it takes an average two years to design, approve, and start a trial. Only half of trials are ever completed. And, while knowledge is exponentially increasing, the groups’ funding has decreased by 20% over the last 8 years.
Moreover, enrollment in trials is abysmal. The American Cancer Society estimates that only 5% of adults with cancer participate.
“Cooperative group studies have steadily improved the care of cancer patients for more than 50 years, but the program is at a breaking point,” said the IOM panel’s chairman, Dr. John Mendelsohn, president of the University of Texas M.D. Anderson Cancer Center in Houston.
“The program urgently needs changes across the board, if it is going to continue producing the kind of studies necessary to answer crucial and fundamental questions about how to successfully treat and prevent cancer, which can't be answered through other means,” he said.
The American Society of Clinical Oncologists (ASCO) applauded the IOM panel’s recommendations. “The Cooperative Clinical Research Program is the jewel in our nation’s cancer research system, and is critical to advancing progress against the disease,” said Dr. Richard L. Schilsky, immediate past president of ASCO, in a statement.
The Cooperative Group Program, which is supported by the National Cancer Institute (NCI), comprises 10 groups that incorporate 3,100 institutions and 14,000 investigators. Some 25,000 patients participate in cooperative trials each year.
The IOM says that the groups have made important contributions over the half-century they have been in existence. For instance, largely as a result of findings from cooperative trials, pediatric cancer survival rates rose from 10% in the 1950s to 80% now, said the report.
Because the program does have the potential to be more efficient and effective, “it is imperative to preserve and strengthen the unique capabilities of the Cooperative Group Program as a vital component in NCI’s translational continuum,” wrote the panelists in the report.
It will be an uphill battle. Currently, funding for the groups makes up only 3% of the NCI’s budget.
Dr. Schilsky said that “the system is being starved of funding.” In real dollars, “the program receives less funding today than it did a decade ago,” he noted.
“ASCO calls on NCI to double its support for cooperative clinical research within five years,” said Dr. Schilsky, a professor of medicine and section chief, hematology/oncology at the University of Chicago Medical Center, who also served on the panel.
The IOM panel called for increased funding, but also urged changes that could be made without new money. It recommended an evaluation of the necessity and contributions of each group, and a shift by the NCI from oversight to pure facilitation of trials. The groups need to move beyond cooperation to “integration,” said the report. That would include a consolidation of some front office and back office operations of the groups and improved collaboration among all the stakeholders.
The ability to recruit, train, and retain enough clinical investigators is also crucial to the rebuilding of the trial system, said the IOM panel. It recommended that health insurers, Medicare, and federal and state health programs cooperate to establish consistent payment policies to cover all patient care costs in a trial, except for the drugs, devices, or diagnostics, which should continue to be paid for by the manufacturers.
Such policies might act as an incentive for patients to participate in trials, said the panel.
The experts also urged the American Medical Association to create new current procedural terminology (CPT) codes that would create a payment pathway for offering, enrolling, managing, and following a patient through a clinical trial. The new codes would reflect the additional time that physicians put in to getting patients into a trial, and for managing potential adverse events.
And, they would likely be a powerful incentive for physicians to consider putting more of their patients in studies, said the panel.
Physicians, indeed, are not happy about reimbursement. An ASCO survey released Apr. 15 showed that one-third of Cooperative Group Sites said they planned to limit participation in those trials due to inadequate per-case reimbursement. Almost 40% of those who were going to limit cooperative studies said they would instead increase their participation in industry-sponsored trials.
Source:http://egmn.idsk.com/stories_us/16_ds_11270391.jsp
Take Care,
Jimmy B
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