A systematic evaluation of compliance and reporting of patient-reported outcome endpoints in ovarian cancer randomised controlled trials: implications for generalisability and clinical practice

Author:

Mercieca-Bebber RebeccaORCID,Friedlander Michael,Calvert Melanie,Stockler Martin,Kyte Derek,Kok Peey-Sei,King Madeleine T.

Publisher

Springer Science and Business Media LLC

Subject

Health Information Management,Health Informatics

Reference36 articles.

1. Au, H. J., Ringash, J., Brundage, M., Palmer, M., Richardson, H., & Meyer, R. M. (2010). Added value of health-related quality of life measurement in cancer clinical trials: The experience of the NCIC CTG. Expert Review of Pharmacoeconomics & Outcomes Research, 10(2), 119–128.

2. Food and Drug Administration. Guidance for Industry: Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labelling Claims2009. Available from: http://www.fda.gov/downloads/Drugs/Guidances/UCM193282.pdf . Accessed 10 Oct 2016.

3. European Medicines Agency. (2016). Appendix 2 to the guideline on the evaluation of anticancer medicinal products in man: The use of patient-reported outcome (PRO) measures in oncology studies. London, UK. http://www.ema.europa.eu/docs/en_GB/document_library/Other/2016/04/WC500205159.pdf . Accessed 10 Oct 2016.

4. Schnipper LE, Davidson NE, Wollins DS, Blayney DW, Dicker AP, Ganz PA, et al. (2016). Updating the American Society of Clinical Oncology Value Framework: Revisions and Reflections in Response to Comments Received. Journal of Clinical Oncology, 34(24), 2925–2934. doi: 10.1200/JCO.2016.68.2518

5. Cherny, N. I., Sullivan, R., Dafni, U., Kerst, J. M., Sobrero, A., Zielinski, C., et al. (2015). A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: The European Society for Medical Oncology magnitude of clinical benefit scale (ESMO-MCBS). Annals of Oncology, 26(8), 1547–1573.

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