The use of patient-reported outcomes in advanced breast cancer clinical trials: a review of the published literature

Author:

Turner-Bowker Diane M.1,Hao Yanni2,Foley Catherine1,Galipeau Nina1,Mazar Iyar1,Krohe Meaghan1,Globe Denise2,Shields Alan L.1

Affiliation:

1. Adelphi Values, Boston, MA, USA;

2. Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA

Funder

Novartis Pharmaceuticals Corporation

Publisher

Informa UK Limited

Subject

General Medicine

Reference35 articles.

1. Cancer statistics, 2015

2. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health. Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims. London, UK: European Medicines Agency, 2005. Available at http://www.ispor.org/workpaper/emea-hrql-guidance.pdf [Last accessed 29 July 2016]

3. European Medicines Agency. Reflection Paper on the Regulatory Guidance for the Use of Health-related Quality of Life (HRQL) Measures in the Evaluation of Medicinal Products. London, Uk: European Medicines Agency, 2005. Available at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/06/WC500168852.pdf [Last accessed 29 July 2016]

4. European Medicines Agency. Reflection Paper on the Use of Patient Reported Outcome (PRO) Measures in Oncology Studies (draft). London, UK: European Medicines Agency, 2014. Available at http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/06/WC500168852.pdf [Last accessed 29 July 2016]

5. The Prognostic Significance of Patient-Reported Outcomes in Cancer Clinical Trials

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