title: [French Health Authority (HAS) Guidance: the post-registration studies on health technologies (drugs, medical devices and instruments): principles and methods].
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.
authors.affiliation: Unité Méthodologie et Études Post-Inscription, Direction de l'Évaluation Médico-Économique et de Santé Publique, HAS, Paris, France. s.stamenkovic@has-sante.fr
authors.forename: Sophie
authors.initials: S
authors.lastname: Stamenkovic
authors.forename: Anne
authors.initials: A
authors.lastname: Solesse
authors.forename: Laura
authors.initials: L
authors.lastname: Zanetti
authors.forename: Pascale
authors.initials: P
authors.lastname: Zagury
authors.forename: Muriel
authors.initials: M
authors.lastname: Vray
mesh_terms: D020811:Biomedical Technology / Q000331:legislation & jurisprudence*; D015340:Epidemiologic Research Design; D004864:Equipment and Supplies; D005602:France; D006801:Humans; D033183:Interdisciplinary Communication; D019370:Observation; D004364:Pharmaceutical Preparations; D017410:Practice Guidelines as Topic; D011358:Product Surveillance, Postmarketing / Q000379:methods; D011635:Public Health Administration / Q000331:legislation & jurisprudence*; D018581:Technology Transfer
chemical_list: D004364:Pharmaceutical Preparations