Patient Reported Outcomes Research Conference

April 24-25, 2006

Overall Conference Feedback:

At the recent Patient Reported Outcomes Research conference that took place April 24-24 in Arlington, Virginia, attendees really found what they were looking for. Feedback focused around a quality conference agenda highlighting the importance of a comprehensive understanding of the new FDA PRO guidance documents as well as business challenges associated with the use of PRO research in health economics and outcomes research.

Topics Addressed Included:

2-Hour Workshop
New FDA Guidance Document Review and Dissemination on Patient Reported Outcomes
The FDA is in the process of drafting a new guidance for assessing the impact and relevance of PROs in clinical research. While the guidance has not yet been formalized, the guidance will address a variety of aspects within PRO management, ranging from the conceptual through practical applications of the reporting results based on PROs, all of which a sponsor submitting a PRO application to the FDA must be prepared for. At the recent FDA/Mayo meeting, representatives from industry, government bodies and academe met to outline, interpret and discuss this new guidance document.

Joseph C. Cappelleri, PhD, MPH
Director, Biostatistics
Pfizer
Jeff A. Sloan, PhD
Professor of Oncology & Health Science Research
Mayo Clinic College of Medicine

*Feedback from this session was phenomenal, with many attendees noting that this workshop was what they came to see, and that Dr. Sloan and Dr. Cappelleri really delivered. The session material covered the new guidance document but also provided candid feedback regarding practical implementation of the guidance.

Keynote Presentation:
Overview of the Science of PROs
Arthur Stone, PhD
Associate Chair, Scientific Advisory Board
invivodata, inc.
Distinguished Professor & Vice-Chair, Psychiatric Department
Director, Applied Behavioral Medicine Research Institute
University of New York at Stony Brook

* Dr. Stone's presentation began the event on the right note, providing an excellent overview and cutting edge summary of conceptual issues and methodologic implications of the scientific foundation of Patient Reported Outcomes.

Development of a Business Case for Investments in Enhanced PRO Capabilities
Maria Watson, PhD
Health Outcomes Manager
GlaxoSmithKline

*Dr. Watson's session provided attendees with practical solutions for securing internal support of their PRO teams and initiatives, allowing delegates insights into tangible examples of successful strategies employed at GlaxoSmithKline.

Health Economics Research and Patient Reported Outcomes
Shelah Leader, PhD
Former Director, PharmacoEconomics and Outcomes Research
MedImmune, Inc.

*Dr. Leader's presentation centered around creative use of PROs and national health data sets that allow organizations to better understand product development, economic models and enhace overall clinical trials.

Recognizing the Impact of Patient Reported Outcomes Research on All Phases of Clinical Trials
Josephine Norquist
Epidemiologist, Scientific Publication
Merck

Challenges with Patient Reported Outcomes in Disease Registries for Ultra-Orphan Drug Populations
Betsy Bogard
Project Manager, Global Registry Programs
Genzyme

AND MANY MORE!!!

f you attended this conference program but were unable to update your materials, we'd be happy to provide you with the updated slides - just email us at: Info@Q1Productions.com