Guidance: Patient-Reported Outcomes

Source:  http://www.fdanews.com/ext/files/06d-0044-gdl0001.pdf

This guidance describes how the FDA evaluates patient-reported outcome (PRO) instruments used as effectiveness endpoints in clinical trials.
It also describes our current thinking on how sponsors can develop and use study results measured by PRO instruments to support claims in approved product labeling.

PRO instruments provide a means for measuring treatment benefits by capturing concepts related to how a patient feels or functions with respect to his or her health or condition.

The concepts, events, behaviors, or feelings measured by PRO instruments can be either readily observed or verified (e.g., walking) or can be non-observable, known only to the patient and not easily verified (e.g., feeling depressed).

2 Responses to Guidance: Patient-Reported Outcomes

  1. JimmyBean says:

    I don’t know If I said it already but …Great site…keep up the good work.🙂 I read a lot of blogs on a daily basis and for the most part, people lack substance but, I just wanted to make a quick comment to say I’m glad I found your blog. Thanks,🙂

    A definite great read..Jim Bean

  2. Hi Jimmy,

    Thanks for appreciating, will try to keep on posting good content which helps others.

    Regards,
    Abhishek

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