A 55-year-old cancer clinical trials network within the National Cancer Institute needs a major overhaul, says a report from the Institute of Medicine.

The network, called the Clinical Trials Cooperative Group Program, enrols 25,000 patients in trials run by 14,000 researchers at 3,100 institutions each year, according to NCI, filling a clinical trial niche that studies at single institutions or private companies can’t address. It funds large Phase 3 trials such as head to head comparisons of different therapies, tests of combinations of drugs made by two or more different companies, preventative measures, and treatments for rare diseases.

But the program is rife with inefficiency and too poorly funded to achieve its objectives, the report says. Trials take two years or more to get off the ground, and NIC funding covers only about half the costs, leaving investigators to seek out the difference from sources such as drug companies.

Compounding the problem is that the use of biomarkers and other recent approaches ups a trial’s cost, making the fact that the program is funded at 1999 levels all the more painful. And until the passage of the US health care bill last month, patients had little incentive to participate because they often incurred costs not covered by many insurance plans.

Only about half of the trials get completed, the report notes, and considering the large numbers of patients and investigators that Cooperative Group trials involve, “the waste of human effort and patient trust and participation is very sad,” says John Mendelsohn, president of the University of Texas M.D. Anderson Cancer Center in Houston, who chaired the IoM committee that wrote the report.

The report makes some rather bold suggestions. For example, do less trials, but do them better — incorporating novel techniques — and fund them in full. The 10 groups that make up the network need some serious trimming as well, the committee says, as does the cumbersome oversight process.

Though the NCI commissioned the report, says Mendelsohn, he’s not so sure the agency – or other stakeholders for that matter — will like the committee’s conclusions. “Everywhere I look, I can see people who are going to have to do a bit of give and take in order to make this work.”