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PATIENT REPORTED OUTCOMES |
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April 2006 |
ISPOR Comments on FDA Guidance for Industry – Patient Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims
http://www.ispor.org/workpaper/ISPOR%20Response%20to%20FDA%20PRO%20Guidance.pdf
|
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March 2005 |
Principles
of Good Practice for the Translation and Cultural
Adaptation Process for Patient-Reported Outcomes (PRO)
Measures: Report of the ISPOR Task Force for Translation
and Cultural Adaptation
Published in Value in Health, Vol.
8, Issue 2, 2005 pp 95-104 http://www.ispor.org/workpaper/research_practices/PROTranslation_Adaptation.pdf |
|
September 2003 |
Incorporating the Patient’s Perspective into Drug
Development and Communication: An Ad Hoc Task Force Report
of the Patient-Reported Outcomes (PRO) Harmonization Group
Meeting at the Food and Drug Administration, February 16,
2001
Published
in
Value in Health Vol. 6 Issue 5, 2003 pp 522-531 |
|
May 2002 |
Patient
Reported Outcomes “PRO’ Symposium: Conceptual and
Methodological Issues, May 19, 2002 (ISPOR pre-meeting
symposium)
http://www.ispor.org/meetings/va0502/symposium.asp |
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QUALITY OF LIFE |
|
February 2001 |
Health-related Quality of Life Harmonization Meeting, FDA,
February 16, 2001http://www.ispor.org/news/articles/0704/patientrep.htm |
|
May 2000 |
Quality of Life Promotional Claims: Methodological Issues and Potential Solutions ISPOR pre-meeting Symposium, May 21, 2000
http://www.ispor.org/meetings/ql0500/index_.asp |
|
March 2000 |
Health-related Quality of Life Harmonization Meeting (Mapi
Research Institute, ERIQA Group, and PhRMA HOC) |
|
April 1999 |
Quality of Life Promotional and Label Claim Issues for Drugs, Biologicals, and Devices Report Issues and Comments published at:
http://www.ispor.org/workpaper/consensus/index.asp#issue1
Development of a Consensus Document as a Supporting Document for FDA and Other Health Regulatory Authorities on Health-Related Quality of Life Guidances: Issues identified and comments given at:
http://www.ispor.org/consensus_index.asp |
|
March 1999 |
Recommendations for Evaluating the Validity of Quality of Life Claims for Labeling and Promotion by Nancy K Leidy, Dennis Ricki, and Bernard Geneste
Published in
Value in Health
Vol. 2, Issue 2, March-April 1999
|
|
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POPULATION HEALTH
|
|
May 2003 |
Summary Measure of Population Health: A Working Group Meeting
Pre-meeting workshop May 17, 2003
http://www.ispor.org/sigs/qol_ph.asp |
|
April 2001 |
Summary Measures of Population Health Status - WHO Cares?
by Paul Kind MPhil, University of York, York, UK
and the ISPOR Quality of Life SIG
http://www.ispor.org/news/articles/0702/measures_.html
|
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October 2000 |
The Joint United Nations Economic Commission for Europe and World Health Organization Meeting on Measuring Health Status, October 23-25, 2000 co-hosted by Statistics Canada, held in Ottawa, Ontario, Canada
Paul Kind attended as the ISPOR representative.
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