Patient Reported Outcomes (PROs): Overview and Guidance for clinical trials and medical product labeling December 12, 2012

This webinar on patient-reported outcomes (PRO) will discuss the conceptual framework of PRO, its reliability, validity, and sensitivity when used in clinical trials. The current guidelines released to standardize PRO usage and interpretation in clinical trials will also be discussed.

Why Should You Attend:

A patient-reported outcome (PRO) is “any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.” Use of such outcome measures has recently increased as PROs have gained greater credibility and can play an important role in drug approval. Regulatory bodies in the US and EU have released guidelines aiming to standardize PRO use and interpretation in clinical trials supporting medicinal product submissions. This webinar provides an overview of the philosophy and assumptions underlying the use of PROs, current perspectives and guidance for their use in clinical trials.

Areas Covered in the Webinar:

- PRO instruments: Conceptual framework, endpoint models.
- Reliability, Validity, and Sensitivity.
- Existing instruments, modified instruments, and newly created instruments. Types of evidence needed for FDA review.
- Protocol Considerations.
- Electronic Data Capture.
- Multiple and Composite Endpoints.
- Statistical Considerations: SAPs
- Interpretation of Clinical Trial Results.

Who will Benefit:

Professionals who will benefit from this webinar include:

- Pharmaceutical and Medical Device Company Representatives and Decision-Makers
- Clinical Research Professionals
- Clinical Protocol Developers
- Clinical Study Managers

Official Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702564?channel=yahooevent