Cultivating Versatility in Statistical Consultants

Posted by Esha Senchaudhuri

Dec 16, 2014 4:56:00 PM

Richard Branson once wrote: “I have always valued capability over expertise. While you may need to hire specialists for some positions, take a close look at people who have thrived in different industries and jobs – they are usually more versatile, have transferable skills, and can potentially tackle problems creatively.”

He goes on to write: “Obviously a healthy mix of experience and novel thinking is the ideal, but on balance I would anticipate more fresh and objective solutions to flow from the smart and curious inexpert outsider than the ‘been there done that’ experts.”

Although the versatility to which Branson alludes is instrumental for successful statistical consulting, it is also obvious that an inexpert outsider would not be able to waltz into the drug development industry and make successful contributions. The expertise that is required is simply too much for a non-specialist. This raises an important question:

How should we, as an industry, walk this fine line between specialized expertise and versatile capabilities? 

Consider, for example, the list of seven questions provided below. 

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Topics: Nitin Patel, Cytel Consulting, Entrepreneurship, Clinical Development Strategy, Richard Branson


Adaptive Designs for Infectious Diseases Clinical Development Strategy

Posted by Esha Senchaudhuri

Dec 11, 2014 1:14:00 PM

 

A common framework for the clinical development of vaccines involves the study of several candidate compounds in Phase 1 followed by the selection of potential vaccine regimens for study in Phase 2 and Phase 3. In the attached presentation, Cytel Consulting’s Jim Bolognese compares traditional and adaptive Phase 1/Phase 2 studies for vaccines and infectious diseases, providing simulations results for both 2-stage and multi-stage adaptive designs. Jim also outlines a structure for a Hybrid Adaptive Study.

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Topics: Infectious Diseases, Clinical Development Strategy, Adaptive Clinical Trials


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