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Panel members discuss IOM Cooperative Group recommendations
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In response to the release of the report, A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI Cooperative Group Program, by the Institute of Medicine, the American Association for Cancer Research held a special session at its 101st Annual Meeting to discuss the newly issued recommendations. The session was led by John Mendelsohn, MD, chair of the Committee on Cancer Clinical Trials and the NCI Cooperative Group Program and president of The University of Texas M.D. Anderson Cancer Center.
According to Mendelsohn, there are more than 800 cancer therapeutics in development, and more oncology drugs have been approved in recent years than drugs to treat any other disease. This growing pipeline of therapies and approvals has led to an emphasis on designing innovative trials that will lead to clinical conclusions, he said.
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“The Cooperative Groups are in an important position to carry out these trials especially from the point of view of what is best for clinical practice,” Mendelsohn said. “Cooperative Groups are complementary to industry trials. Industry’s primary goal is to develop novel therapies and gain FDA approval. Cooperative Groups are more likely to do trials that industry is less likely to do.”
These can include examining the effectiveness of approved therapies, combining novel agents, looking at therapies for rare diseases, researching multimodality therapies, conducting screening and prevention trials and examining how these treatments affect quality of life.
“Challenges to the Cooperative Group system are known to anyone who is involved,” Mendelsohn said. “The clinical trials infrastructure has not evolved to adequately accommodate the rapid pace of biomedical discovery. The funding is stagnant. The processes are inefficient. There is extensive and complex government oversight, and there is a ongoing trend to conduct trials overseas.”
In response to this growing problem, the IOM coordinated a committee and asked it to make suggestions on how to:
- Improve the design, review and operation of trials.
- Reduce the time from initial concept to final approval.
- Prioritize trials and trial sights on scientific merit and performance.
- Increase clinician and patient participation.
- Make greater use of technologies such as imaging and biomarkers to select therapies to test.
- Match patients with therapies and to monitor patient response.
- Define standards for minimum data required to establish safety and efficacy.
- Reduce costs and adequately fund high-quality trials.
- Promote greater collaboration among various stakeholders.
The committee concluded that the academic, governmental and commercial stakeholders must join with the public to develop a 21st century clinical trial system to more effectively leverage scientific advancements and translate them into public health benefits by improving the science, technology, efficiency and timely completion of the very best cancer clinical trials, Mendelsohn said. – by Leah Lawrence