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The Marshall Protocol Study Site > PROF. MARSHALL'S PERSPECTIVE > Prof. Marshall's Perspective > Dr Janet Whitley, of FDA, explains Clinical Studies


Dr Janet Whitley, of FDA, explains Clinical Studies
 Moderated by: Prof Trevor Marshall
 

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Prof Trevor Marshall
Foundation Staff


Joined: Fri Jul 9th, 2004
Location: Thousand Oaks, California USA
Posts: 16043
Status:  Offline
 Posted: Thu Jun 16th, 2011 11:46

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At our Chicago conference in 2005, Dr Janet Whitley, of FDA, gave an excellent explanation of the Drug Approval process, and especially the types of Clinical Studies which we will probably be using.

The next time anybody tells you that the MP hasn't been subjected to a placebo, double-blind, clinical trial please tell them to bring their understanding up-to-date by looking through this video.

Even though even more new study methodologies have occurred in the last 5 years (such as 'adaptive' trials), this video will  give a good start in understanding the importance of "historical comparator" and other methodologies which have been around for quite some time...

This was originally on our DVDs of the conference. I dragged out the original files from 2005 so that this video can be considered "remastered". In a couple of years I may well release an HD "gold remaster" edition :)

http://www.youtube.com/watch?v=SYaRIIiZ4GI

..Trevor..


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