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Review

Patient-reported outcomes in support of oncology product labeling claims: regulatory context and challenges

Pages 407-420 | Published online: 09 Jan 2014

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Yanni Hao, Meaghan Krohe, Iyar Mazar, Nina Galipeau, Catherine Foley, Denise Globe, Diane M. Turner-Bowker & Alan L. Shields. (2016) Patient-reported outcomes in advanced breast cancer: inside the label and approval documents. Expert Review of Quality of Life in Cancer Care 1:3, pages 197-205.
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Wen-Hung Chen, Lori D McLeod, Lauren M Nelson, Valerie SL Williams & Sheri E Fehnel. (2014) Quantitative challenges facing patient-centered outcomes research. Expert Review of Pharmacoeconomics & Outcomes Research 14:3, pages 379-386.
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Articles from other publishers (13)

Michela Meregaglia, Francesco Malandrini, Stefania Angelini & Oriana Ciani. (2023) The Assessment of Patient-Reported Outcomes for the Authorisation of Medicines in Europe: A Review of European Public Assessment Reports from 2017 to 2022. Applied Health Economics and Health Policy 21:6, pages 925-935.
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Maria Manuel Teixeira, Fábio Cardoso Borges, Paula Sousa Ferreira, João Rocha, Bruno Sepodes & Carla Torre. (2022) A review of patient-reported outcomes used for regulatory approval of oncology medicinal products in the European Union between 2017 and 2020. Frontiers in Medicine 9.
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Oriana Ciani & Carlo Baldassarre Federici. (2020) Value Lies in the Eye of the Patients: The Why, What, and How of Patient-reported Outcomes Measures. Clinical Therapeutics 42:1, pages 25-33.
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Paul Kamudoni, Nutjaree Johns & Sam SalekPaul Kamudoni, Nutjaree Johns & Sam Salek. 2018. Living with Chronic Disease: Measuring Important Patient-Reported Outcomes. Living with Chronic Disease: Measuring Important Patient-Reported Outcomes 143 165 .
Leslie Wehrlen, Mike Krumlauf, Elizabeth Ness, Damiana Maloof & Margaret Bevans. (2016) Systematic collection of patient reported outcome research data: A checklist for clinical research professionals. Contemporary Clinical Trials 48, pages 21-29.
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Yanni Hao, Meaghan Krohe, Andrew Yaworsky, Alan L. Shields, Iyar Mazar, Catherine Foley & Denise Globe. (2016) Clinical Trial Patient-reported Outcomes Data: Going Beyond the Label in Oncology. Clinical Therapeutics 38:4, pages 811-820.
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Sam Salek & Paul Kamudoni. (2015) Streamlining the Validation of Patient Reported Outcome (PRO) Measures in Drug Regulatory Processes. Pharmaceutical Medicine 29:5, pages 255-268.
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Melanie Calvert, Derek Kyte, Helen Duffy, Adrian Gheorghe, Rebecca Mercieca-Bebber, Jonathan Ives, Heather Draper, Michael Brundage, Jane Blazeby & Madeleine King. (2014) Patient-Reported Outcome (PRO) Assessment in Clinical Trials: A Systematic Review of Guidance for Trial Protocol Writers. PLoS ONE 9:10, pages e110216.
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Jing Zhao, Xinxiao Chen, Aimu Zhang, Feng Xu, Meilong Hu, Congying Xie & Shengliu Xue. (2014) A pilot study of combination intraperitoneal recombinant human endostatin and chemotherapy for refractory malignant ascites secondary to ovarian cancer. Medical Oncology 31:4.
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Dominique Niesten, Krista van Mourik & Wil van der Sanden. (2013) The impact of frailty on oral care behavior of older people: a qualitative study. BMC Oral Health 13:1.
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Zheng-kun Hou, Feng-bin Liu, Ji-qian Fang, Xiao-ying Li, Li-juan Li & Chu-hua Lin. (2012) Advising on Preferred Reporting Items for patient-reported outcome instrument development: the PRIPROID. Chinese Journal of Integrative Medicine 19:3, pages 172-181.
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G.D. Slade. (2012) Are Dental Health Behaviors Rational, after All?. Journal of Dental Research 92:1, pages 5-6.
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P. Wimberger, H. Gilet, A.-K. Gonschior, M.M. Heiss, M. Moehler, G. Oskay-Oezcelik, S.-E. Al-Batran, B. Schmalfeldt, A. Schmittel, E. Schulze & S.L. Parsons. (2012) Deterioration in quality of life (QoL) in patients with malignant ascites: results from a phase II/III study comparing paracentesis plus catumaxomab with paracentesis alone. Annals of Oncology 23:8, pages 1979-1985.
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