Literature review of methods to translate health-related quality of life questionnaires for use in multinational clinical trials.
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| Acquadro C, Conway K, Hareendran A, Aaronson N; European Regulatory Issues and Quality of Life Assessment (ERIQA) Group. Literature review of methods to translate health-related quality of life questionnaires for use in multinational clinical trials. Values in Health 2008; 11(3) : 509-521 |
An Evaluation of the EMEA recommendations on the use of Quality of Life measures in drug approval.
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| Apolone G, De Carli G, Brunetti M, Garattini S. An Evaluation of the EMEA recommendations on the use of Quality of Life measures in drug approval. PharmacoEconomics 2001; 19(2) : 187-195 |
Patient Reported Outcomes and Regulatory Issues: the Example of Health-related Quality of Life - A European Guidance Document for the Improved Integration of HRQL Assessment in the Drug Regulatory Process.
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| Chassany O, Sagnier P, Marquis P, Fulleton S, Aaronson N. Patient Reported Outcomes and Regulatory Issues: the Example of Health-related Quality of Life - A European Guidance Document for the Improved Integration of HRQL Assessment in the Drug Regulatory Process. Drug Information Journal 2002; 36(1) : 209-238 |
Task Force Report of the Patient-Reported Outcomes Harmonization group: Too Much Harmony, Not Enough Melody?
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| William Lenderking- Task Force Report of the Patient-Reported Outcomes Harmonization group: Too Much Harmony, Not Enough Melody? Value In Health 2003; 6 (5) : 503-504 |
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.
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| Acquadro C, Berzon R, Dubois D, Kline Leidy N, Marquis P, Revicki D, Rothman,M for the PRO Harmonization Group. 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. Value in Health 2003; 5 : 522-531 |
A Comprehensive Strategy for the Interpretation of Quality-of-Life Data Based on Existing Methods
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| Patrick Marquis, Olivier Chassany, Linda Abetz- A Comprehensive Strategy for the Interpretation of Quality-of-Life Data Based on Existing Methods Value In Health 2004; 7 (1) : 93-104 |
Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels
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| Richard J. Willke, Laurie B. Burke, Pennifer Erickson- Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels Controlled Clinical Trials 2004; 25 : 535-552 |