Monthly Archives: August 2010

Five Keys to Successful Adaptive Trials

Posted on 27 August 2010 by Ask-Cato.com Contributor

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 … Continue reading →

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CDRH Proposes Changes to the 510(k) Pathway

Posted on 23 August 2010 by Leo DiNapoli

All for one, one for all, that is our device. – Alexandre Dumas The Center for Devices and Radiological Health (CDRH) has been somewhat under fire in recent years, so it surprised no one when it undertook a long look … Continue reading →

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Important Steps Forward for Early Detection and Diagnose of Alzheimer’s Disease

Posted on 20 August 2010 by Ask-Cato.com Contributor

Image via Wikipedia In a recent report by Geert De Meyer of Ghent University in Belgium and colleagues, titled “Diagnosis-Independent Alzheimer Disease Biomarker Signature in Cognitively Normal Elderly People” (Arch Neurol. 2010;67(8):949-956) it was demonstrated that measuring certain proteins in … Continue reading →

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Joint Statistical Meetings 2010 Retrospective: A CRO Statistician’s Perspective

Posted on 16 August 2010 by Ask-Cato.com Contributor

Image via Wikipedia The Joint Statistical Meetings is often a good place to learn about emerging issues in the analysis of clinical trials (and all of the other fields that statistics touches, as a matter of fact). Here are just a … Continue reading →

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Accelerated Approval

Posted on 11 August 2010 by Leo DiNapoli

Image via Wikipedia One must strike the right balance between speed and quality. – Clare Short Accelerated approval has been in the news for a while, so it seems like a good time to go over some of the basics:  … Continue reading →

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