ERIQA/PRO harmonization

Articles

Regnault A, Acquadro C. FDA Workshop Measurement in Clinical Trials: Review and Qualification of Clinical Outcome. Patient Reported Outcomes Newsletter. Spring Issue 2012; 47, pp.12-17.

Acquadro C., Berzon R., Dubois D., Nancy Kline L., Marquis P., Revicki D., and Rothman M. 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; 6(5):522-531.

Wiklund I, Acquadro C, Chassany O. Patient-Reported Outcomes in a regulatory environment, there is a need for guidance. In Qualité de vie liée à l'état de santé: critère d'évaluation. Edited by Chassany O, Caulin C. Collection Recherche clinique & Décision Thérapeutique. Springer, Paris © 2002:63-69.

Conway K, Mear I, Acquadro C for the ERIQA Group. An attempt to develop minimal requirements for the 1 st step of cross-cultural adapation of patient reported outcomes (PROs) measures. Quality of Life Newsletter. 2001:27(July-Dec):6

Acquadro C for the PRO Harmonization Group. Important issues in patient reported outcomes (PROs) Research. A brief report of the activities of the PRO harmonization group. Quality of Life Newsletter. 2001:27(July-Dec):8

Acquadro C for the ERIQA Group. A decisive step towards the recognition of patient reported outcomes in clinical trials. Quality of Life Newsletter. 2001:26 (Jan-Jun):24-25

Acquadro C for the ERIQA Group. The European Regulatory Issues on Health-Related Quality of Life Assessment (ERIQA) Project: Preliminary Results and Plans for the future. Quality of Newsletter. 2000:24(Jan-Jun):1-3.

ERIQA Group. The European Regulatory Issues on QoL Assessment (ERIQA) project. Quality of Newsletter. 1999:21(Jan-Apr):1-2.

Workshops

Acquadro C for the ERIQA Group. The European Regulatory Issues on quality of Life Assessment (ERIQA) project. Plenary session at the 7 th annual symposium of contributed papers on QoL Evaluation, Hilton Head, USA, April 2000

Acquadro C for the ERIQA Group. The European Regulatory Issues on Quality of Life Assessment (ERIQA) project. ISPOR Health Policy Session at the 5th annual international meeting, International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Crystal City, USA, May 2000.

Oral Presentations

Acquadro C. for the ERIQA Group. EMEA/ERIQA Guidelines for Translation and Cultural adaptation. Presented at the 6 th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research, Barcelona, Spain, November 2003 during the Quality of Life Special Interest Group form “Translation and Cultural Adaptation: is it time for a harmonized approach to Linguistic Validation?”

Acquadro C, Staniek V for the ERIQA Group. The European Regulatory Issues on Quality of Life Assessment (ERIQA) Project. Presented at the Pan Pacific Conference of ISOQOL . Tokyo, Japan, April 2001.

Staniek V, Acquadro Cfor the ERIQA. Role of Health-Related Quality of Life (HRQL) outcomes in the European Drug Regulatory Process: A review of the EMEA documents. Taking the QoL research into the new millenium. Presented at the Pan Pacific Conference of ISOQOL. Tokyo, Japan, April 2001.

Acquadro C for the ERIQA Group. The European Regulatory Issues on quality of Life Assessment (ERIQA) project. Presented at the Health Outcomes Conference, Canberra, Australia, July 1999.

Posters

Lobo-Luppi L, Acquadro C. Pre-selection of EMEA efficacy working party guidance for review and comments. Quality of Life Research. 2002;11(7):685. Presented at the 9 th Annual Conference of the International Society for Quality of Life Research (ISOQOL), Orlando, USA, November 2002.

Acquadro C for the ERIQA Group. A decisive step towards the recognition of patient reported outcomes in clinical trials: report of a meeting at the FDA on February 16, 2001. Quality of Life Research. 2001;10(3):270. Presented at the 8th Annual Conference of the International Society for Quality of Life Research (ISOQOL), Amsterdam, The Netherlands, November 2001.

Acquadro C, Staniek V for the ERIQA Group. Role of Health-Related Quality of Life (HRQL) outcomes in the European Drug Regulatory Process: A review of the EMEA documents. Value in Health. 2001;4(2):177. Presented at the 6 th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Arlington, VA, USA, May 2001.

Acquadro C, Marquis P for the ERIQA Group. Results of the spring 2000 HRQL harmonization meeting. Submitted for publication in Quality of Life Research. Quality of Life Research. 2000;9(3):27. Presented at the 7th Annual Conference of the International Society for Quality of Life Research (ISOQOL), Vancouver, Canada, October 2000.

Acquadro C for the ERIQA Group. Role of HRQL evaluation in the drug regulatory process: preliminary results from a European Regulatory survey. Value in Health. 2000;3(2):164. Presented at the 5th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Crystal City, USA, May 2000.

Marquis P, Abetz L, Acquadro C for the ERIQA Group. Health-Related Quality of Life and Regulatory issues: comparison of US and European initiatives. Value in Health. 2000;3(2):165. Presented at the 5th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Crystal City, USA, May 2000.

Chassany O, Fullerton S, Wiklund I, Apolone G, Acquadro C, Jambon B for the ERIQA Group. Minimal standards for the validation of quality of life instruments used in clinical trials. Value in Health. 2000;3(2):219. Presented at the 5th Annual International Meeting, International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Crystal City, USA, May 2000.

Acquadro C. The European regulatory issues on quality of life assessment (ERIQA) project. Quality of Life Research. 1999;8(7):658. Presented at the 6 th Annual Conference of the International Society for Quality of Life Research (ISOQOL), Barcelona, Spain, November 1999.

Wiklund I, Apolone G, Acquadro C, Chassany O, Jabmon B, Fullerton S. A comparison of the EMEA and FDA draft guidelines in congestive heart failure (CHF) with particular reference to Health-Research quality of life (HRQL) outcomes. Quality of Life Research. 1999;8(7):658. Presented at the 6 th Annual Conference of the International Society for Quality of Life Research (ISOQOL), Barcelona, Spain, November 1999.

Apolone G, Brunetti M, De Carli G, Acquadro C. A review and evaluation of the EMEA documents with reference to QoL assessment. Quality of Life Research. 1999;8(7):657. Presented at the 6 th Annual Conference of the International Society for Quality of Life Research (ISOQOL), Barcelona, Spain, November 1999.