Tag Archive: randomization

Jul 28 2011

Imaginary patients, Imaginary data, et Cetero, et Cetero…

The FDA recently issued a letter to a CRO based in Cary, NC, outlining serious violations at one of their facilities including “widespread falsification of dates and times in laboratory records… and the apparent manipulation of equilibration samples to meet predetermined acceptance criteria.”  This letter is a follow-up to two on-site audits, conducted as a …

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Aug 27 2010

Five Keys to Successful Adaptive Trials

Running adaptive trials is not easy. However, in a world of skyrocketing drug development costs, these trials are set to become essential tools in any drugmaker’s repertoire, especially early in clinical development. A poorly done adaptive trial can not only result in trial failure (i.e. failure of the study to produce useful information about the …

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