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  • 1.  Clinical Trials References

    Posted 12-03-2014 10:33
    Hello,

    Would anyone happen to know of any good references that may be useful for providing information regarding study design consderations for retrospective trials using real world data (e.g., claims data bases & electronic medical records) with respect to appropriate designs, controlling for confounding, analysis plans, etc?

    Thanks.

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    James Eudicone
    HEOR Statistics & Programming
    AstraZeneca
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  • 2.  RE: Clinical Trials References

    Posted 12-04-2014 10:39
    Hi James,

    The AHRQ (Agency for Healthcare Research and Quality) have published two documents; 1) Developing a Protocol for Observational Comparative Effectiveness Research: A user's guide, and 2) Registries for Evaluating Patient Outcomes: A user's guide. These are available for free download at www.ahrq.gov and are a good place to start. I've found them to be quite useful.

    I hope this helps!
    Stephanie

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    Stephanie Sproule
    Principal Consultant / Biostatistician
    Optimum Statistics Inc.
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    Original Message


  • 3.  RE: Clinical Trials References

    Posted 12-05-2014 14:53
    Hi, Stephanie and James!

    ISPOR also has a host of good study design methods under 'Good Outcomes Research Practices'
    at
    http://www.ispor.org/workpaper/practices_index.asp

    best regards,

    Marlene Egger

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    Marlene Egger
    Professor
    University of Utah, DFPM
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    Original Message


  • 4.  RE: Clinical Trials References

    Posted 12-06-2014 19:51
    One reference that might match what you're looking for is Paul R. Rosenbaum, Design of Observational Studies, 2010 Springer Science+Business Media, LLC, ISBN 978-1-4419-1212-1. 

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    Eric Siegel
    Biostatistician
    Univ of Arkansas for Medical Sciences of Biostatistics
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    Original Message


  • 5.  RE: Clinical Trials References

    Posted 12-08-2014 11:48
    See OHDSI (pronounced "odyssey") at http://www.ohdsi.org/, and recent papers of David Madigan at http://scholar.google.com/citations?sortby=pubdate&hl=en&user=XDajlywAAAAJ&view_op=list_works

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    Martha Smith
    University of Texas
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    Original Message