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Approving Cancer Therapies Faster

Approving Cancer Therapies Faster

Reported September 15, 2008

(Ivanhoe Newswire) — Cancer therapy has been a savior for many, but it can take up to 12 years to submit a new anti-cancer agent to the FDA and even then, only five to 10 percent are approved. Now, the National Cancer Institute’s (NCI) Translational Research Working Group (TRWG) has created a set of tools to make necessary cancer therapies available to the public sooner.

Each of the six “Pathways to Clinical Goals,” as the tools are called, involves a series of steps to clarify and streamline the research process. The six pathways cover six topics including anti-cancer agents (drugs or biologics), biospecimen-based assessment methods, immune response modifiers, image-based assessment modalities, intervention devices and lifestyle alterations. For each pathway, researchers must answer questions regarding the topic. If any of the answers are “no,” then research leaders are recommended to reevaluate their research plans to make them more effective.

 

 

The TRWG hopes the guidelines will be widely used. “The NCI supports a great deal of excellent translational research, but inefficiencies arising from a lack of communication and coordinated effort prevent many promising leads from reaching clinical trials and eventual approval,” Lynn Matrisian, Ph.D., a special assistant in the Office of the Director at NCI and co-chair of the TRWG, was quoted as saying. “We hope these pathways will help in placing each research opportunity in the broader context of tangible cancer detection, diagnosis, prevention, and treatment strategies.”

SOURCE: Clinical Cancer Research, published online September 15, 2008

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