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Biomarker breakthrough highlights potential of adaptive trials

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Researchers reported a major breakthrough on their use of biomarkers in a study of several existing lung cancer therapies, and their fresh insights into adaptive clinical trials are likely to have a major impact on the way new cancer drugs are studied.

The Battle cancer study was mounted by the renowned M.D. Anderson Cancer Center. Tumor biopsies from the 255 patients enrolled in the study were examined and the patients were randomly assigned one of four cancer therapies. Eight weeks after dosing began, the researchers again examined the samples to see if disease progression had been stymied or if the drug should be changed. This same kind of adaptive trial design can be used to identify specific groups of patients who are likely to respond to an experimental therapy, greatly improving the chance of success in mid- to late-stage trials.

"This is the future," Tyler Jacks, a cancer researcher at Massachusetts Institute of Technology and president of the American Association of Cancer Research, told the Wall Street Journal. "This is how drugs will be developed and clinical trials organized."

"A trial like this is unprecedented," said Anil Potti, an associate professor of medicine at Duke University. "It shows that getting biopsies and treating patients based on those biopsies is feasible in lung cancer today. It's a huge advance in lung cancer research and in the whole concept of personalized medicine."

- read the story from the Wall Street Journal
- here's the Bloomberg article

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