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Cancer drug trials program in crisis

The system for conducting cancer clinical trials in the United States is "at a breaking point" and needs a major overhaul, a panel of experts said on Thursday.
/ Source: Reuters

The system for conducting cancer clinical trials in the United States is "at a breaking point" and needs a major overhaul, a panel of experts said on Thursday.

The Institute of Medicine panel said inefficient management, complicated government oversight and inadequate funding hamper the ability of the National Cancer Institute's Clinical Trials Cooperative Group Program to design and run studies that answer important questions about new therapies.

"Cooperative group studies have steadily improved the care of cancer patients for more than 50 years, but the program is at a breaking point," John Mendelsohn, president of the University of Texas M.D. Anderson Cancer Center in Houston, who chaired the panel, said in a statement.

He said the program's effectiveness is threatened just as biomedical research is making rapid advances in more personalized cancer treatments.

"A few isolated or partial measures won't suffice," Mendelsohn said.

"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."

The Cooperative Group Program involves more than 3,100 institutions and 14,000 investigators who enroll more than 25,000 patients in clinical trials each year.

For these trials to be successful, they require a significant investment of time by busy doctors and other healthcare workers to manage patients' care during the studies, according to the report by the 17-member panel appointed by the IOM, one of the National Academies of Sciences.

Doctors not reimbursed enough, panel says
But doctors are less willing to take part because they are not reimbursed adequately, the panel said in the report.

Doctors and their clinics must pay for as much as half of the cost of clinical trials and nearly all must seek support from outside sources such as drug companies.

And trials are getting more expensive as researchers develop more personalized cancer treatments, including the use of so-called biomarkers to see how a treatment is working.

When inflation is taken into account, there is less money for the trials now than in 1999 — meaning researchers will be unable to conduct increasingly complex clinical trials that focus on developing drugs tailored to a person's genetic makeup.

One major problem is that the system of designing a clinical trial is lengthy and redundant, and can take an average of two years to complete.

In fact, only about 60 percent of National Cancer Institute-sponsored late-stage clinical trials are completed, a waste of human and financial resources, the committee said.

The group urged the National Cancer Institute, one of the National Institutes of Health, to devote more of its research budget to the program. If not, groups should take on fewer NCI-funded trials, the panel said.

The American Society of Clinical Oncology applauded the IOM report and urged the National Cancer Institute to double its support for the network within five years.

An ACSO-sponsored survey of more than 500 U.S. and Canadian groups found as many as a third plan to reduce their participation in NCI-sponsored trials.

ASCO said NCI devotes about $145 million a year to the program, representing just 1.2 percent of the institute's 2009 fiscal year budget of about $5 billion.

"Considering the program's vital importance to the nation's fight against cancer, it is clearly not in the public interest that it receives such a small fraction of NCI's overall budget," Dr. Richard Schilsky, past president of the ASCO, said in a statement.