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Patient reported outcomes: looking beyond the label claim

The use of patient reported outcome scales in clinical trials conducted by the pharmaceutical industry has become more widespread in recent years. The use of such outcomes is particularly common for products developed to treat chronic, disabling conditions where the intention is not to cure but to a...

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Detalles Bibliográficos
Autores principales: Doward, Lynda C, Gnanasakthy, Ari, Baker, Mary G
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2010
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2936442/
https://www.ncbi.nlm.nih.gov/pubmed/20727176
http://dx.doi.org/10.1186/1477-7525-8-89
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author Doward, Lynda C
Gnanasakthy, Ari
Baker, Mary G
author_facet Doward, Lynda C
Gnanasakthy, Ari
Baker, Mary G
author_sort Doward, Lynda C
collection PubMed
description The use of patient reported outcome scales in clinical trials conducted by the pharmaceutical industry has become more widespread in recent years. The use of such outcomes is particularly common for products developed to treat chronic, disabling conditions where the intention is not to cure but to ameliorate symptoms, facilitate functioning or, ultimately, to improve quality of life. In such cases, patient reported evidence is increasingly viewed as an essential complement to traditional clinical evidence for establishing a product's competitive advantage in the marketplace. In a commercial setting, the value of patient reported outcomes is viewed largely in terms of their potential for securing a labelling claim in the USA or inclusion in the summary of product characteristics in Europe. Although, the publication of the recent US Food and Drug Administration guidance makes it difficult for companies to make claims in the USA beyond symptom improvements, the value of these outcomes goes beyond satisfying requirements for a label claim. The European regulatory authorities, payers both in the US and Europe, clinicians and patients all play a part in determining both the availability and the pricing of medicinal products and all have an interest in patient-reported data that go beyond just symptoms. The purpose of the current paper is to highlight the potential added value of patient reported outcome data currently collected and held by the industry for these groups.
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spelling pubmed-29364422010-09-10 Patient reported outcomes: looking beyond the label claim Doward, Lynda C Gnanasakthy, Ari Baker, Mary G Health Qual Life Outcomes Commentary The use of patient reported outcome scales in clinical trials conducted by the pharmaceutical industry has become more widespread in recent years. The use of such outcomes is particularly common for products developed to treat chronic, disabling conditions where the intention is not to cure but to ameliorate symptoms, facilitate functioning or, ultimately, to improve quality of life. In such cases, patient reported evidence is increasingly viewed as an essential complement to traditional clinical evidence for establishing a product's competitive advantage in the marketplace. In a commercial setting, the value of patient reported outcomes is viewed largely in terms of their potential for securing a labelling claim in the USA or inclusion in the summary of product characteristics in Europe. Although, the publication of the recent US Food and Drug Administration guidance makes it difficult for companies to make claims in the USA beyond symptom improvements, the value of these outcomes goes beyond satisfying requirements for a label claim. The European regulatory authorities, payers both in the US and Europe, clinicians and patients all play a part in determining both the availability and the pricing of medicinal products and all have an interest in patient-reported data that go beyond just symptoms. The purpose of the current paper is to highlight the potential added value of patient reported outcome data currently collected and held by the industry for these groups. BioMed Central 2010-08-20 /pmc/articles/PMC2936442/ /pubmed/20727176 http://dx.doi.org/10.1186/1477-7525-8-89 Text en Copyright ©2010 Doward et al; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Commentary
Doward, Lynda C
Gnanasakthy, Ari
Baker, Mary G
Patient reported outcomes: looking beyond the label claim
title Patient reported outcomes: looking beyond the label claim
title_full Patient reported outcomes: looking beyond the label claim
title_fullStr Patient reported outcomes: looking beyond the label claim
title_full_unstemmed Patient reported outcomes: looking beyond the label claim
title_short Patient reported outcomes: looking beyond the label claim
title_sort patient reported outcomes: looking beyond the label claim
topic Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2936442/
https://www.ncbi.nlm.nih.gov/pubmed/20727176
http://dx.doi.org/10.1186/1477-7525-8-89
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