With the advent of personalized medicine, long-term gains in cancer survival could be improved by running smaller, faster trials with less stringent evidence criteria, a researcher told the 2011 European Multidisciplinary Cancer Congress in late September. The introduction of targeted treatments means the traditional large-scale clinical trial is not always the most effective way of getting new treatments to the cancer patients who need them, said Dr. Marie-Cécile Le Deley, associate professor of clinical epidemiology and biostatistics at the Institut Gustave-Roussy, Villejuif, France. The increased knowledge of tumor biology has meant that common cancers are more and more frequently recognized as consisting of small subsets with particular abnormalities. These abnormalities might be targeted by specific therapies, but the ability to test many of the promising agents available is hindered by the need to invest many resources into running a single large trial over many years, Le Deley said.
Working with colleagues at the Mayo Clinic in Rochester, Minn., Le Deley simulated a series of two-treatment superiority trials (where a new treatment is compared to the existing standard therapy), taking place over 15 years and using different design parameters. These included the number of trials performed during the period, and the criteria used to adopt an experimental treatment as the new standard. The researchers used these studies to estimate, for different strategies, the survival improvements that could be expected over a 15-year research period.
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