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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/18771

Title: Endpoints for relative effectiveness assessment (REA) of pharmaceuticals
Authors: Pavlovic, Mira
Teljeur, Conor
Wieseler, Beate
Klemp, Marianne
Neyt, Mattias
Issue Date: 2014
Abstract: Objectives: Clinical endpoints are defined as valid measures of clinical benefit or harm due to treatment, that describe the impact of treatment on how a patient feels, functions, and survives. The choice of endpoints and the manner in which they are reported have a major impact on the relative effectiveness assessment (REA) of pharmaceuticals. The aim of this article is to describe the guideline development process and the key findings that set a framework for appropriate use of endpoints in REAs in Europe. Methods: A multi-health technology assessment (HTA)-agency collaborative process in EUnetHTA JA1 was used to scope, draft, and finalize methodological guidelines for REA in Europe. Results: Patient-relevant clinical endpoints can be broadly categorized into: mortality, morbidity and health-related quality of life. A clinical endpoint is a main symptom or sign of a disease that is clinically relevant, valid, reproducible and responsive to change. Preference is for long-term or final endpoints whenever possible. Surrogate endpoints may be used when there is compelling evidence of a clear and consistent correlation of treatment effects on the surrogate and final outcome of interest. Conclusions: The relevance and hierarchy of the different types of clinical endpoints depend on the research question, disease, and the treatment investigated. Not only the primary endpoint, but also other relevant endpoints are assessed in comparison to adequate comparator(s). This simultaneous assessment of all relevant endpoints is a hallmark of REA.
Notes: [Pavlovic, Mira] Haute Autor Sante, F-93218 La Plaine St Denis, St Denis La Pla, France. [Teljeur, Conor] Hlth Informat & Qual Author, Dublin, Ireland. [Wieseler, Beate] Inst Qual & Efficiency Hlth Care, Cologne, Germany. [Klemp, Marianne] Norwegian Knowledge Ctr Hlth Serv, Oslo, Norway. [Cleemput, Irina; Neyt, Mattias] Belgian Hlth Care Knowledge Ctr, Brussels, Belgium. [Cleemput, Irina] Hasselt Univ, Diepenbeek, Belgium.
URI: http://hdl.handle.net/1942/18771
DOI: 10.1017/S0266462314000592
ISI #: 000351057600006
ISSN: 0266-4623
Category: A1
Type: Journal Contribution
Validation: ecoom, 2016
Appears in Collections: Research publications

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