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Assessing positive outcomes of phase III trials
Date:12/3/2010

t the news treatment in place of the standard treatment" and investigators should try to reach at least a clinically important difference that was specified in the protocol.

They also suggest that the FDA and EMEA "should define what constitute a positive trial based on the concept of establishing a meaningful clinical benefit for patients similar to those included in any given trial."

In an accompanying editorial, J. Jack Lee, Ph.D., of the M.D. Anderson Cancer Center, writes that this "excellent commentary" calls for a new drug approval paradigm and challenges both the medical and statistical communities to find a better way to assessing whether a drug really works.

Lee goes on to argue for the adoption of the Bayesian approach in contrast to the more conventional frequentist approach. "Statistics in medicine has passed through its infancy and childhood. As it moves into its adolescence, the growing pains of reconciling frequentist and Bayesian views continue," he writes. In his view, though, the "roadblocks" of the Bayesian approach, namely the notion of subjectivity and computation difficulty, have been overcome.

"The Bayesian approach is complementary to and can provide a superior alternative to the frequentist paradigm," Lee writes. "I encourage medical researchers to have an open mind, learn more about Bayesian methods, and apply them to provide a more accurate statistical assessment of the results in clinical trials."


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Contact: Kristine Crane
jncimedia@oxfordjournals.org
301-841-1285
Journal of the National Cancer Institute
Source:Eurekalert

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