Ensure Content Validity of PRO Concepts and Capture Patient Data with New Technology
May 7-8, 2012
- Philadelphia, Pennsylvania
Utilize PRO Data to Enhance Patient Quality
The patient perspective is a crucial source of information that bio/pharmaceutical and medical device companies are taking into consideration as they run clinical trials. Patient Reported Outcomes (PRO) not only help in labeling claims and support clinical outcomes, they also help physicians determine appropriate treatment therapies. With the growing concern to the regulatory environment of PROs, it is important to discuss how to best utilize PRO data for improved patient outcomes.
Hear from bio/pharmaceutical leaders on the following topics being researched:
- Responder Analysis
- Content Validity
- Mode Equivalents
- PRO Data in the Label
- RASCH Analysis
- ePRO and the Mobile Device
- PROs in Confirmatory Clinical Trials
- PRO as a Non-Primary Endpoint
- FDA and EMA Regulations
