Tag Archives: statistical analysis

Statistics and Statisticians in Clinical Trials – Beginning with the End in Mind

Posted on 9 September 2010 by Ask-Cato.com Contributor

Cover of The 7 Habits of Highly Effective People Begin with the end in mind … is imagination–the ability to envision in your mind what you cannot at present see with your eyes. It is based on the principle that all … Continue reading →

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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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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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Statistical Implications of Protocol Amendments

Posted on 26 July 2010 by Ask-Cato.com Contributor

Clinical trial protocol amendments occur for good reasons. An unanticipated safety issue may arise, new information about the disease or treatment may suggest alterations, or recruitment and enrollment may not go as planned. One aspect of protocol amendments that often … Continue reading →

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New Draft Guidance on Noninferiority Trials

Posted on 16 June 2010 by Evan Richardson

In March 2010, the FDA issued a draft guidance on the use of noninferiority (NI) trials.  While not in final form, this guidance should help sponsors understand the issues the FDA considers when reviewing NI trials. In contrast to statements … Continue reading →

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