Tag Archives: endpoints

Statistical Reviews of Case Report Forms

Posted on 28 April 2011 by Ask-Cato.com Contributor

A statistical review of a trial case report form (CRF) is highly important for various reasons. The project statistician is aware of the planned primary and secondary endpoint analyses and knows what data will be needed to implement these analyses. … Continue reading →

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Analysis of FDA Guidance on Adaptive Designs

Posted on 10 May 2010 by Ask-Cato.com Contributor

In February 2010, the FDA published a draft guidance on Adaptive Design Clinical Trials for Drugs and Biologics (“the guidance”). This highly anticipated guidance has come out in draft form 4 years after then FDA deputy commissioner Dr. Scott Gottlieb’s … Continue reading →

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