PRO Guidance from the FDA
In December 2009 the FDA finalized PRO Guidance for Label Claims. This is great news for ePRO as the FDA emphasizes the importance of the patient perspective, that can represent a well defined and reliable measure of a claim for your compound. The purpose of this guidance is to outline the steps required to develop a PRO instrument from hypothesis of a concept or claim, through data item evaluation, collection, cognitive debriefing, interpretation, revision and finalization. Content validity is critical.
Click here to download a copy of the FDA PRO Guidance
To develop a PRO from scratch is a complex undertaking, and modifying an existing PRO can be more involved than anticipated. But PRO data has many uses beyond label claims and ERT consultants can direct you every step of the way.
The Guidance only addresses ePRO specifically with regard to data accessibility at the investigator site. All of ERT ePRO solutions will meet this requirement
ERT has been taking paper PROs, modifying, validating, and applying them in an ePRO environment for over 30 years. From hundreds of simple, linear patient diaries to the complicated clinical assessments, we have the expertise and partners to help you get from any starting point - a blank sheet of paper, or a validated PRO, - to valid ePRO collected data for FDA submission.
