A call to action to harmonize patient-reported outcomes evidence requirements across key European HTA bodies in oncology-Reference-Cited by-同舟云学术

A call to action to harmonize patient-reported outcomes evidence requirements across key European HTA bodies in oncology

Published:2022-09 Issue:29 Volume:18 Page:3323-3334
ISSN:1479-6694
Container-title:Future Oncology
language:en
Short-container-title:Future Oncology

Author:

Chassany Olivier¹²^ORCID,Engen Anke van³,Lai Livia⁴,Borhade Kunal⁵,Ravi Manukiran⁵,Harnett James⁶,Chen Chieh-I⁶,Quek Ruben GW⁶

Affiliation:

1. Health Economics Clinical Trial Unit, Hôpital Hotel-Dieu, AP-HP, 1 Place du Parvis Notre Dame, Paris, 75004, France

2. Patient-Reported Outcomes Unit (PROQOL), UMR 1123, Université Paris Cité, INSERM, Paris, F-75004, France

3. IQVIA, Herikerbergweg 314, 1101CT Amsterdam, The Netherlands

4. IQVIA, 3 Forbury Place, 23 Forbury Rd, Reading, RG1 3JH, UK

5. IQVIA, Omega Block, Embassy Tech Square, Outer Ring Road, Bangalore, 560103, India

6. Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Rd, Tarrytown, NY 10591, USA

Abstract

Patient-reported outcome (PRO) data are increasingly being included in Health Technology Assessment (HTA) submissions for oncology drugs. This study aims to provide differences in PRO evidence requirements in oncology across key HTA bodies and calls for its harmonization. Method guidance provided by HTA bodies in Germany, France and the UK, and analysis of HTA reports of 20 oncology case studies were evaluated in this review. Differences exist between HTA bodies regarding guidance on how PRO data should be collected, reported and analyzed as well as how the data are reviewed and considered in oncology HTAs. HTA bodies can play a key role to harmonize PRO method guidance in collaboration with regulators and sponsors.

Funder

Regeneron Pharmaceuticals

Publisher

Future Medicine Ltd

Subject

Cancer Research,Oncology,General Medicine

Link

https://www.futuremedicine.com/doi/pdf/10.2217/fon-2022-0374

Reference71 articles.

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3. US FDA. Guidance for industry. Patient-reported outcome measures: use in medical product development to support labeling claims (2009). www.fda.gov/media/77832/download

4. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Reflection Paper on Patient Focused Drug Development (PFDD) (2020). www.ich.org/page/reflection-papers#1-1

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