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Thread: New LFA Flare Definition

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    tgal's Avatar
    tgal is offline Super Moderator Super ModeratorEmperor of the Solar System
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    Default New LFA Flare Definition

    I know many of you do not read the Feeds thread but this one was so important I had to post it here. The bold section is mine. Please note the and/or in the definition.
    __________________________________________________ ________________________

    Washington, DC) The Lupus Foundation of America (LFA) spearheaded a four-year worldwide initiative with more than 120 lupus experts from 11 countries, the pharmaceutical and biotechnology industries, and federal agencies, which resulted in the first-ever global definition of a lupus flare. The development of Lupus Foundation of America Flare Definition (LFA-Flare) helps to overcome long-standing barriers to the development of new, safe, and more tolerable treatments for lupus.

    For the past 15 years, many trials of new investigational medicines for lupus have failed to show significant benefits for patients. A consistent and meaningful definition for a lupus flare is critical to evaluating the effectiveness of treatment over time. The new definition will enable more precise outcome measures for future studies, such as the number of flares or the time between flares. This will have a positive impact on the quality and scientific basis of clinical trials, which are required by the U.S. Food and Drug Administration (FDA) to demonstrate the effectiveness of any new therapy before it can be approved for general use in patients.

    The consensus definition is: A flare is a measurable increase in disease activity in one or more organ systems involving new or worse clinical signs and symptoms and/or lab measurements. It must be considered clinically significant by the assessor and usually there would be at least consideration of a change or an increase in treatment.
    Mari

    Success is not final, failure is not fatal: it is the courage to continue that counts.

    ~Winston Churchill~







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    rob is offline Super Moderator Super ModeratorEmperor of the World
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    This could could cause all sorts of major (and hopefully positive) changes down the road. Nice find Mari.

    Rob

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    tgal's Avatar
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    I agree! I was so excited!!!
    Mari

    Success is not final, failure is not fatal: it is the courage to continue that counts.

    ~Winston Churchill~







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