Category Archive: Statistics

Apr 28

Statistical Reviews of Case Report Forms

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. The project statistician also has a clearer view of how the data will affect the …

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Sep 28

Future of Clinical Trials – Conference Review

On September 15-17, I attended the Future of Clinical Trials conference produced by Leo Intelligence. The conference consisted of professionals from many aspects of clinical drug development. The first two talks set the stage for the rest of the conference and detailed the political and industry collaboration trends currently occurring. As political pressures are making drug …

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Sep 15

Future of Clinical Trials Conference 2010

The Future of Clinical Trials conference will be held in San Francisco, CA from 15-17 September 2010.  The focus of this year’s conference is, “Exploring Efficiencies and Strategies for Smarter Clinical Trials.”  The three day conference has an impressive list of speakers lined up, and promises to: Enlighten you to emerging breakthroughs in clinical trial …

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Sep 09

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

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 things are created twice. There is a mental (first) creation, and a physical (second) creation. …

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Aug 27

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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Aug 16

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

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 few of the topics that stood out in my mind: Adaptive trials: of course, adaptive …

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Aug 16

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

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 few of the topics that stood out in my mind: Adaptive trials: of course, adaptive …

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Jul 26

Statistical Implications of Protocol Amendments

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 gets overlooked is the statistical analysis. This is because it is not always obvious that …

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May 24

When Should You Write your Statistical Analysis Plans?

Recently in the LinkedIn Biostatistics group, one user asked: A client wants me to prepare final SAP [statistical analysis plan] shortly after protocol and CRFs are finalized for a Phase 3 trial, to submit to FDA prior to start of study. I find this unusual. Any experience doing so? When? As of the time of …

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May 10

Analysis of FDA Guidance on Adaptive Designs

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 famous keynote speech on the topic accelerated interest on the topic. In the intervening years, …

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