Patient-reported outcomes validated in phase 3 clinical trials: a targeted literature review
Author:
Affiliation:
1. Astellas Pharma Europe Ltd, Addlestone, UK
2. Mapi Research Trust, Lyon, France
3. Astellas Pharma Inc, Westborough, MA, USA
Publisher
Informa UK Limited
Subject
General Medicine
Link
https://www.tandfonline.com/doi/pdf/10.1080/03007995.2023.2224164
Reference30 articles.
1. US Food & Drug Administration. Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims [Internet]. 2009 [cited 2022 Jun 22]. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/patient-reported-outcome-measures-use-medical-product-development-support-labeling-claims.
2. Developing a Valid Patient-Reported Outcome Measure
3. A Catalyst for Transforming Health Systems and Person-Centred Care: Canadian National Position Statement on Patient-Reported Outcomes
4. Patient-reported outcomes in clinical practice
5. The importance of patient-reported outcomes in clinical trials and strategies for future optimization
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