How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory-HTA parallel scientific advice
| Autor: | Jane Moseley, Antje Behring, Frank Pétavy, Mercè Obach, Niklas Hedberg, Guido Rasi, Leeza Osipenko, Arantxa Catalan, Eva‐Maria Zebedin, Pierluigi Russo, Marco Massari, Marc Van de Casteele, Spiros Vamvakas, Elangovan Gajraj, Margherita Pagnini, Giovanni Tafuri |
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| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
Technology Assessment
Biomedical Biomedical COVERAGE DECISIONS AGENCIES Settore MED/07 03 medical and health sciences 0302 clinical medicine Qualitative analysis Technology Assessment EMA Agency (sociology) Humans media_common.cataloged_instance Medicine DRUGS Clinical Trials Pharmacology (medical) European Union 030212 general & internal medicine Pharmacology & Pharmacy European union Drug Approval media_common Pharmacology OUTCOMES Science & Technology HEALTH TECHNOLOGY ASSESSMENTS business.industry 030503 health policy & services Health technology Health Technology Assessment Public relations Advice (programming) Patient population Data extraction MARKET parallel scientific advice agreement regulatory Program Evaluation Government Regulation 0305 other medical science business ACCESS Life Sciences & Biomedicine |
| Zdroj: | British Journal of Clinical Pharmacology |
| Popis: | BACKGROUND: In 2010, the European Medicines Agency (EMA) initiated a pilot project on parallel scientific advice with Health Technology Assessment bodies (HTABs) that allows manufacturers to receive simultaneous feedback from both the European Union (EU) regulators and HTABs on their development plans for medicines. AIMS: The present retrospective qualitative analysis aimed to explore how the parallel scientific advice system is working and levels of commonality between the EU regulators and HTABs, and among HTABs, when applicants obtain parallel scientific advice from both a regulatory and an HTA perspective. METHODS: We analysed the minutes of discussion meetings held at the EMA between 2010, when parallel advice was launched, and 1 May 2015, when the cutoff date for data extraction was set. The analysis was based on predefined criteria and conducted at two different levels of comparison: the answers of the HTABs vs. those of the regulators, and between the answers of the participating HTA agencies. RESULTS: The analysis was based on 31 procedures of parallel scientific advice. The level of full agreements was highest for questions on patient population (77%), while disagreements reached a peak for questions on the study comparator (30%). With regard to comparisons among HTABs, there was a high level of agreement for all domains. CONCLUSIONS: There is evident commonality, in terms of evidence requirements between the EU regulators and participating HTABs, as well as among HTABs, on most aspects of clinical development. Indeed, regardless of the question content, the analysis showed that a high level of overall agreement was reached through the process of parallel scientific advice. ispartof: BRITISH JOURNAL OF CLINICAL PHARMACOLOGY vol:82 issue:4 pages:965-973 ispartof: location:England status: published |
| Databáze: | OpenAIRE |
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