Regulatory Open Forum

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  • 1.  Patient Registries

    Posted 01-Jul-2015 10:36
    Does anyone have any good information out there about pre-study patient registries? Basically building a potential patient database via internet before the study begins.

    Thanks so much for any insight

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    Renee Greene
    United States
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  • 2.  RE: Patient Registries

    Posted 02-Jul-2015 08:30
    Hello Renee,
    We have used pre-study patient registries as a strategy for identifying potential patients for clinical studies in rare disease populations. Typically they are set up as natural history or "research study invitation" registries.  In some cases they can provide individual patient data (for example on rate of progression of a disease marker or outcome) that can then be used as baseline data for comparison in a treatment trial after a period of time. For browsing through some good examples, you might want to look at the AHRQ Registry of Patient Registries website:  https://patientregistry.ahrq.gov/

    If you search on rare disease there you will find a good number.

    I'd be glad to talk about this further if you want to get in touch.

    Best regards,
    Kathy
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    Kathryn Wekselman
    Senior Director, Regulatory and Scientific Affairs
    CTI Clinical Trial and Consulting Services
    Cincinnati OH
    United States
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