FDA's New Guidance on Using Patient Diaries to Capture Primary Endpoints

Why should you take this eConference?
Because the Center for Devices recently endorsed the draft guidance “Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.”

Objective:
Why and how to use Patient Diaries to capture the primary study data

Description:
Learn when Patient Diaries should be used to capture primary endpoints, how to develop and validate them, and the special statistical considerations that apply to their data.

Presenter:
Michelle Secic is the President of Secic Statistical Consulting, Inc. where she works on a variety of medical research projects. The second edition of her book, "How To Report Statistics in Medicine" is due out in May 2006. Ms. Secic can be reached at consult@secicstats.com

The purchase is $403 for the CD. Event materials are available on the CD itself. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.