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Guide de la Haute autorité de santé (HAS) : les études post-inscription sur les technologies de santé (médicaments, dispositifs médicaux et actes) : principes et méthodes

Authors :
Sophie Stamenkovic
Anne Solesse
Laura Zanetti
Pascale Zagury
Muriel Vray
Pascal Auquier
Elisabeth Baumelou
Frédéric de Bels
Marie-Christine Bene
Alain Bernard
Jean-Pierre Boissel
Marie-Odile Carrere
Pierre Czernichow
Benoit Dervaux
Eveline Eschwege
Pascale Fabbro-Peray
Bruno Falissard
Annie Fourrier
Didier Guillemot
François Lacoin
Maryse Lapeyre-Mestre
Patrick Maison
Jacques Massol
Emmanuel Oger
Françoise Roudot-Thoraval
Patrice Trouiller
Mahmoud Zureik
Source :
Therapies. 67:409-421
Publication Year :
2012
Publisher :
Elsevier BV, 2012.

Abstract

The assessment of a health technology is frequently accompanied by uncertainty about its impact, at short or long terms, on the health of the population. The Health Authorities may request additional « post-registration » data that will allow a relevant reassessment of these technologies. The responsibility to collect this information lies with the industry and the HAS evaluates the methodology. This guideline provides practical benchmarks on methodological aspects of these studies. It describes the different types of studies to consider depending on the objectives, including the use of databases and cohorts and European studies. It emphasizes the importance of establishing a scientific committee, clearly defining the objectives of the study, justifying the methodological choices, documenting the representativeness or completeness of centers, investigators and patients, limiting the number of lost of follow-up patients and missing data, describing the statistical analysis methods, the bias and their possible impact on results. The publication of the results of these studies is strongly encouraged.

Details

ISSN :
00405957
Volume :
67
Database :
OpenAIRE
Journal :
Therapies
Accession number :
edsair.doi...........ecd7c7d4dcdf5ea22ea12aa035d748f4
Full Text :
https://doi.org/10.2515/therapie/2012065