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Experts Urge Fixes for Clinical Trials System in 'Crisis'
Date:4/15/2010

Federal report says more funding, streamlined procedures will help save lives long-term

THURSDAY, April 15 (HealthDay News) -- The U.S. cancer clinical trials system is nearing a "state of crisis" and needs to be repaired if gains in cancer treatment are going to continue, says a new government report.

The authors of the report, commissioned by the U.S. National Cancer Institute (NCI) and conducted by the Institute of Medicine (IOM), calls for a major revamping of the current system, including an injection of what they say is much-needed funding, along with reductions in bureaucratic red tape.

"The system is not broken but it could be doing a lot more if it were working better," said Dr. John Mendelsohn, chair of the committee that prepared the report and president of the University of Texas M.D. Anderson Cancer Center in Houston.

"The problems articulated by the Institute of Medicine are very real and they do create a troubling paradox," added Dr. Louis M. Weiner, director of the Georgetown Lombardi Comprehensive Cancer Center in Washington, D.C., who has been a member of the cooperative trials program most of his career.

"In an era where we have more understanding of cancer and how to attack it by going after particular targets and combinations of targets, and have a larger number of credible candidate drugs and concepts to test than at any other time, yet we have a regulatory and operational system that can't get out of its own way," he said. "It's just a tremendous shame."

"The consequence is that people will suffer and die needlessly because we haven't been able to effectively get new treatments into the marketplace where they belong," Weiner added. "What we see in the cancer world is probably a harbinger of what's likely to happen elsewhere."

The NCI-supported Clinical Trials Cooperative Group Program is comprised of more than 3,100 institutions and 14,000 investigators overse
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