Group Works to Streamline Cancer Therapy Approvals

Sept. 20 --

FRIDAY, Sept. 19 (HealthDay News) -- A cancer research group has developed a new set of tools that it hopes will hasten and improve the process of developing and approving new drugs to fight this leading cause of death in the Unites States.

The National Cancer Institute's Translational Research Working Group (TRWG), whose ideas are published in the Sept. 15 issue of Clinical Cancer Research, breaks the process into six "Pathways to Clinical Goals" and charts the steps to clarify and streamline the research process.

"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," TRWG co-chair Lynn Matrisian, a special assistant in the National Cancer Institute's office of the director, said in a news release. The TRWG, formed in 2005 with the goal of accelerating the pace of translational cancer research, expects its pathways to be a major step forward in this process.

It can take up to 12 years for a new anti-cancer agent to reach the Food and Drug Administration, and, even then, only 5 percent to 10 percent are ever approved for use.

The six pathways address anti-cancer agents (drugs or biologics), biospecimen-based assessment methods, immune response modifiers, image-based assessment modalities, intervention devices, and lifestyle alterations. Each follows a flowchart. For example, in the anti-cancer agent pathway, researchers are encouraged at the outset to address three questions:

  • Is the empirical basis for attributing clinical potential (alone and/or in combination) convincing?
  • Does the envisioned clinical need justify expenditure of resources?
  • Is it feasible to identify/develop an agent against this target?
  • If the answer to any is "no," the researchers are encouraged to direct their efforts toward more effective plans.

    "We hope these pathways will help in placing each research opportunity in the broader context of tangible cancer detection, diagnosis, prevention, and treatment strategies. We believe the NCI's experience will be an important resource for other groups advancing translational research as well," Matrisian said.

    More information

    The National Cancer Institute has more about cancer research.

    SOURCE: American Association for Cancer Research, news release, Sept. 15, 2008