Papers published by ERIQA Group

There have been 6 articles about Patient Reported Outcomes and Health Related Quality of Life research, which were written on behalf of the ERIQA Group and published in professional journals including PharmacoEconomics, Drug Information Journal, Value in Health and Controlled Clinical Trials. The most recent article of the ERIQA Group “Literature Review of Methods to Translate Health-Related Quality Of Life (HRQL) Questionnaires for Use in Multinational Clinical Trials” is in press in Value in Health (VIH) and will be available online at the end of 2007.

■ 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

■ 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

■ 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

■ 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

■ 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

■ 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