Patient Reported Outcomes Harmonization Group

"Harmonizing Patient Reported Outcomes issues used in Drug Development and Evaluation"

 

 

Nov. 1999: ISOQOL Satellite Symposium Barcelona, Spain
One of the conclusions of his symposium was to suggest the idea of organizing Harmonization Meetings on HRQL evaluation.

1. The European Regulatory Issues on Quality of Life Assessment  (ERIQA) Project: Overview.
Catherine Acquadro, MD
2. Quality of Life Claims: The ISOQOL Perspective. 
 Ivan Barofsky, Ph.D.
3. HRQoL & Regulatory Issues in Europe. 
Olivier Chassany, MD
4. HRQL and Regulatory Issues : Status Comparison of US and EU initiatives.
Patrick Marquis, MD
5.  Perspectives for the future 
Jean Paul Gagnon, Ph.D.
6.  HRQL and Regulatory Initiatives in the United  States: a Synthesis.
Dennis Revicki, Ph.D.
March 31, 2000: HRQL Harmonization Meeting Pentagon City, VA, USA
1.  Comparison of Health related Quality of Life and Regulatory Initiatives in Europe and in the USA --selection of problematic issues and possible solutions
2. HRQL & Regulatory Issues, Analysis & Comparison of Initiatives - Similarities and Differences
3. Data Analysis- Interpretation and Reporting
4. Conditions for claim
5. Report 
September 14, 2000: The added value of HRQL Outcomes: Preliminary Conclusions FDA, Rockville, MD, USA
1. The Added Value of HRQL Outcomes: PreliminaryConclusions
2. Report: Summary of Decisions
February 16, 2001: Important Issues in PRO Research FDA, Rockville, MD,USA
1. Important Issues in Patient Reported Outcome (PRO) Research 
2. Report: A decisive step in the recognition of Patient Reported Outcomes in clinical trials - Important Issues in Patient Reported Outcomes (PROs) Research
November 11, 2001: ISPOR Meeting Cannes France
1. Patient Reported Outcomes  (PRO) Harmonization Team Group Reports
March 1, 2002: Important Issues in PRO Research Continued Discussions, FDA, Rockville, MD,USA

1. Important Issues in PRO Research Continued Discussions, FDA, Rockville, MD,USA