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PROLABELS

Articles

Kitchen H, Rofail D, Caron M, Emery MP. Oncology patient-reported claims: maximizing the chances for success. Ecancermedicalscience 2011;5:212.

Caron M, Emery MP, Marquis P, Piault E, Scott J. Recent Trends in the Inclusion of Patient-Reported Outcome (PRO) Data in Approved Drugs Labeling by the FDA and EMEA. Patient Reported Outcomes Newsletter. Fall Issue 2008:40:8-10.

Posters

Stott T, Lien S, Desvignes-Gleizes C, Bothorel S, Sherafat-Kazemzadeh R. 10 Years on From the FDA’s Women’s Health Research Roadmap: A Landscape Review of Female-Specific Clinical Outcome Assessments (COA), Health Agency Recommendations and Drug Label Claims With COA Related to Women’s Health. Presented at ISPOR Europe 2024.

Perrier LL, Caron M, Murison A. Overview of the PROLabels database six years after its implementation. Presented at ISPOR 5th Asia Pacific-Conference, Taipei, Taiwan, September 2012.

Caron M, Acquadro C, Emery MP. What is the influence on clinical research of the EMA guideline on medicinal products for the treatment of Alzheimer's disease? Presented at the ISPOR 17th Annual International Meeting, Washington DC, USA, June 2012.

Caron M, Emery MP. The role of Patient-Reported Outcomes (PRO) as primary endpoints in the evaluation of medicines approved with PRO claims. Value in Health, November 2010; 13 (7), pA338:PMC49. Presented at ISPOR 13th Annual European Congress, Prague – Czech Republic, November 2010.

Caron M, Emery MP. PRO labelling claims in antineoplastic agents. Value in Health, May 2010; 13 (3), pA45:PCN111. Presented at ISPOR 15th International Meeting, Atlanta – USA, May 2010.

Caron M, Emery MP. Comparison of the PRO endpoints found in labeling claims of products for the treatment of psoriasis with those recommended by the corresponding EMEA guidance.
Value in Health, May 2010; 13 (3), pA148:PSS15. Presented at ISPOR 15th International Meeting, Atlanta – USA, May 2010.

Caron M, Emery M P, Marquis P, Piault E, Scott J. Patient-Reported Outcome (PRO) labeling claims in pain treatment: overview of us and European drug approvals. Presented at the 14th Annual International Meeting of the ISPOR, Orlando, USA, May 2009.

Caron M, Emery MP, Marquis P, Piault E. Update of recent trends in the inclusion of Patient-Reported Outcome (PRO) data in approved drugs labeling by the FDA and EMEA. Presented at the 11th Annual European Meeting of the ISPOR, Athens, Greece, November 2008.

Anfray C, Emery MP. Access to Patient-Reported Outcome (PRO) instruments and their translations in the light of FDA recommendations. Presented at the 13th Annual International Meeting (ISPOR), Toronto, Ontario, Canada, May 3-7, 2008.

Caron M, Emery MP, Marquis P, Piault E. Recent trends in the inclusion of Patient-Reported Outcome (PRO) data in approved drugs labeling by FDA and EMEA. Presented at the 13th Annual International Meeting (ISPOR), Toronto, Ontario, Canada, May 3-7, 2008.

Emery MP, Caron M, Marquis P, Piault E. Patient-Reported Outcome (PRO) labeling claims in Parkinson's disease: overview of US and European drug approvals. Value in Health. November/December 2007;10(6):A392. Presented at the Tenth Annual European Congress (ISPOR), Dublin, Ireland, October 20, 2007.

Caron M, Marquis P, Piault E, Emery MP. Analysis of the Patient-Reported Outcome (PRO) endpoints found in labeling claims of asthma drugs in Europe. Presented at the Annual Congress 2007 of the European Respiratory Society (ERS), Stockholm, Sweden September 2007.

Emery MP, Caron M, Marquis P, Piault E. Patient Reported Outcomes in labeling for oncology products: review of FDA and EMEA labels. Value in Health. May/June 2007;10(3):A141. Presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 12th Annual International Meeting, Arlington, May 2007.

Emery MP, Caron M, Marquis P, Acquadro C, Piault E. Comparison of the PRO endpoints found in labeling claims of urinary incontinence drugs with those recommended by the corresponding EMEA Note for Guidance. Value in Health. November/December 2006;9(6):A391. Presented at the 9th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Copenhagen, October 2006.

Caron M, Emery MP, Marquis P, Acquadro C, Piault E. The PROLabels database: a new on-line tool to explore the wording and types of PRO included in approved medicinal products labels. Value in Health. May/June 2006;9(3):A61. Presented at the 13th Annual Conference of the International Society for Quality of Life Research (ISOQOL), Lisbon, October 2006 and at the 11th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Philadelphia, May 2006.

Oral Presentations

Marquis P, Caron M, Emery M.P, Scott J.A, Arnould B, Acquadro C. The role of health-related quality of life data in the drug approbal processes in the USA and Europe: A review of guidance documents and authorizations of medicinal products from 2006 to 2010. Presented at ISOQOL 18th Annual Conference, Denver - USA, October 2011.