Navigation Links
Experts Urge Fixes for Clinical Trials System in 'Crisis'

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 overseeing trials involving more than 25,000 patients each year. It is the largest clinical trials network in the nation.

"Cooperative groups have made tremendous contributions, especially looking at new uses for approved therapies and combining novel agents that come from different sponsors, and looking at rare diseases," Mendelsohn said. "The most glorious example is all the cooperative group trials in pediatrics that led to changing the prognosis in childhood leukemia from a six months median survival to a cure rate above 75 percent."

But such victories could be in danger, a result of funding cuts, inefficiencies and other problems, the IOM report said. Since 2002, for instance, funding for the program has plummeted by 20 percent.

The report, titled A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program, identified four major areas of concern.

The first was the sheer amount of time it takes to set up a trial.

"We've learned that it takes more than two years for the average trial to be finalized, to write the trial," Mendelsohn said. "If a trial takes more than a couple of years to develop, it rarely finishes. It becomes out of date, new things come along. If you're going to do trials, you should be able to design them in less than a year, get them out and do them."

The second goal involves making greater use of scientific innovation -- such as biomarkers that can more quickly predict a tumor's response to a drug -- in clinical trials. That means that, instead of doing a trial on just breast cancer patients, researchers might select breast, colon and lung cancer patients who all had the same tumor mutation.

The report authors also want to explore ways in which two or three drugs could be used in combination to combat a particular type of cancer. For example, the IOM is recommending that the U.S. Food and Drug Administration help speed the process by which experimental drugs can be used, alone or together, without sacrificing patient safety.

The third goal involves identifying and supporting those trials that have the greatest chance of success and making sure they make it through to completion. "There are a number of ways we can centralize credentialing and improve [participant] enrollment approaches," Mendelsohn said.

Finally, the report pointed out that both patients and physicians need to be better compensated for their participation in clinical trials so they'll be motivated to participate.

One idea: make sure that public and private health plans cover the full expense to patients of participating in a clinical trial. "Patients are sometimes turning down trials because they're worried they won't be reimbursed for care, whereas if they took the standard therapy that might not work as well, they can be sure it will be paid for," Mendelsohn explained. "The new health-care bill includes provisions for [covering] the non-experimental care in a clinical trial."

Weiner added: "It's a big challenge. There are a lot of competing constituencies and a lot of competing priorities. It is a difficult river to navigate but every one of the stakeholders wants to do what's right for people who suffer from cancer and that can be highly motivating. [But] I don't think it's a matter of reshuffling processes to be more efficient. This is going to require a decision by society that clinical trials are important."

More information

The U.S. National Cancer Institute has more on the cooperative trials program.

SOURCES: John Mendelsohn, M.D., president, University of Texas M.D. Anderson Cancer Center, Houston; Louis M. Weiner, M.D., director, Georgetown Lombardi Comprehensive Cancer Center, Washington, D.C.; April 15, 2010, Institute of Medicine report, A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program

Copyright©2010 ScoutNews,LLC.
All rights reserved

Related medicine news :

1. Childhood obesity interventions must begin early, UCSF experts say
2. Childhood Obesity Interventions Must Begin Early, UCSF Experts Say
3. McGraw-Hill Signs Corporate Visions Experts to Book Deal
4. Arizona Attracts Businesses Looking For Data Center Experts
5. Stirling Dental Laboratory, Experts in Emergency Denture Repair Service, Gives Back to Community
6. Experts Say Its Not So Bad to Go a Little Mad
7. Two Top Sleep Experts Team Up On New Pillow Collection
8. Bipartisan Capitol Hill Media Event: Health Experts, Lawmakers to Urge Federal Government to Fix the Funding Failure for Chronic Viral Hepatitis
9. Alert: Bloomberg to Gather Healthcare Experts in Chicago, April 27th
10. David Wolfe Hosts 3-Day Longevity Conference: Top Wellness Experts Reveal Tomorrow's Best Natural Health and Nutrition Information Today
11. Experts support new federal center for Medicare and Medicaid innovation
Post Your Comments:
(Date:11/25/2015)... ... 2015 , ... Brillianteen, McGaw YMCA’s student-produced musical show, will ... Anniversary Brillianteen Revue, scheduled for March 4-6, 2016. Auditions for this final production ... been a treasured tradition for numerous families in the Evanston community. Over the ...
(Date:11/25/2015)... , ... November 25, 2015 , ... “While riding the ... inventor, from Bronx, N.Y. “I thought there had to be a convenient and comfortable ... PROTECTOR. , The PROTECTOR enables disabled individuals to safely travel during cold or inclement ...
(Date:11/25/2015)... , ... November 25, 2015 , ... ... provide scholarships for people struggling with eating disorders as a result of the ... second annual event, held at Fox Run Golf Club in Eureka, will help ...
(Date:11/25/2015)... ... 25, 2015 , ... "When I underwent breast reconstruction following ... uncomfortable," said an inventor from Bronx, N.Y. "In order to meet my own ... BRA for added comfort and support. The bra is easier to put on ...
(Date:11/25/2015)... ... ... An unlikely combination of recycled plastic shopping bags in ... to have a more dignified and comfortable night’s sleep. , Residents of Friendship ... bags into sleeping mats for the homeless. The project, according to Jeannette ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... 26, 2015 ... "2016 Future Horizons and Growth Strategies ... Market: Supplier Shares, Country Segment Forecasts, Competitive ... offering. --> ) has ... Future Horizons and Growth Strategies in the ...
(Date:11/26/2015)... 2015 ... the  "2016 Future Horizons and Growth ... Monitoring (TDM) Market: Supplier Shares, Country ...  report to their offering.  --> ... addition of the  "2016 Future Horizons ...
(Date:11/26/2015)... DUBLIN , Nov. 26, 2015 ... the addition of the "2016 Future Horizons ... Monitoring (TDM) Market: Supplier Shares, Country Segment Forecasts, ... offering. --> ... comprehensive analysis of the Italian therapeutic drug monitoring ...
Breaking Medicine Technology: