Grasping the FDA's PRO Guidance, Applied Clinical Trials, August 2006

Summary

By setting ground rules for the use of Patient Reported Outcomes (PROs), the FDA has implicitly given credibility to PROs as the basis for evaluating drugs and biologics. However, some researchers perceive a few challenges in the guidance FDA has issued. The objective of this article is to give an overview of the PRO Guidance for clinical researchers implementing PROs, with specific focus on how to document the history and psychometric properties of their PRO instruments and how to determine the amount of revalidation, if any, might be necessary in light of the guidance.

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