@article{7bc11a1595374200ac43d8a4be428e92,
title = "The impact of parallel regulatory–health technology assessment scientific advice on clinical development. Assessing the uptake of regulatory and health technology assessment recommendations",
abstract = "Aims: The parallel regulatory–health technology assessment scientific advice (PSA) procedure allows manufacturers to receive simultaneous feedback from both EU regulators and health technology assessment (HTA) bodies on development plans for new medicines. The primary objective of the present study is to investigate whether PSA is integrated in the clinical development programmes for which advice was sought. Methods: Contents of PSA provided by regulators and HTA bodies for each procedure between 2010 and 2015 were analysed. The development of all clinical studies for which PSA had been sought was tracked using three different databases. The rate of uptake of the advice provided by regulators and HTA bodies was assessed on two key variables: comparator/s and primary endpoint. Results: In terms of uptake of comparator recommendations at the time of PSA in the actual development, our analysis showed that manufacturers implemented comparators to address both the needs of regulators and of at least one HTA body in 12 of 21 studies. For primary endpoints, in all included studies manufacturers addressed both the needs of the regulators and at least one HTA body. Conclusions: One of the key findings of this analysis is that manufacturers tend to implement changes to the development programme based on both regulatory and HTA advice with regards to the choice of primary endpoint and comparator. It also confirms the challenging choice of the study comparator, for which manufacturers seem to be more inclined to satisfy the regulatory advice. Continuous research efforts in this area are of paramount importance from a public health perspective.",
keywords = "clinical development, European Medicines Agency, health technology assessment, HTA bodies, parallel scientific advice, regulatory",
author = "Giovanni Tafuri and In{\^e}s Lucas and Steve Estev{\~a}o and Jane Moseley and Anne d'Andon and Hannah Bruehl and Elangovan Gajraj and Sonia Garcia and Niklas Hedberg and Marco Massari and Andrea Molina and Merc{\`e} Obach and Leeza Osipenko and Frank Petavy and Marco Petschulies and Caridad Pontes and Pierluigi Russo and Anja Schiel and {Van de Casteele}, Marc and Zebedin-Brandl, {Eva Maria} and Guido Rasi and Spiros Vamvakas",
note = "Funding Information: 1Italian Medicines Agency (AIFA), Via del Tritone, 181-00187 Rome, Italy, 2European Medicines Agency (EMA), 30 Churchill Place, London E14 5EU, United Kingdom, 3The National Health Care Institute (ZIN), 4 Eekholt, Diemen 1112 XH, The Netherlands, 4Haute Autorit{\'e} de Sant{\'e} (HAS), 5 Avenue du Stade de France, 93210 Saint-Denis, France, 5The Federal Joint Committee (G-BA), Wegelystr. 8, D-10623 Berlin, Germany, 6The National Institute for Health and Care Excellence (NICE), 10 Spring Gardens, London SW1A 2BU, United Kingdom, 7Spanish Agency of Medicines and Medical Devices (AEMPS), Calle Campezo 1, Edificio 8, 28022 Madrid, Spain, 8Dental and Pharmaceutical Benefits Agency (TLV), Fleminggatan 18, 104 22 Stockholm, Sweden, 9Servei Catal{\`a} de la Salut (CatSalut), Travessera de les Corts, 131-159, Edifici Ol{\'i}mpia, 08028 Barcelona, Spain, 10Norwegian Medicines Agency (NoMA), Str{\o}msveien 96, 0663 Oslo, Norway, 11National Institute for Health and Disability Insurance (INAMI-RIZIV), Avenue de Tervueren 211, 1150 Bruxelles, Belgium, and 12Main Association of Austrian Social Security Institutions (HVB), Kundmanngasse 21, A-1031 Vienna, Austria Publisher Copyright: {\textcopyright} 2018 The British Pharmacological Society Copyright: Copyright 2019 Elsevier B.V., All rights reserved.",
year = "2018",
month = may,
doi = "10.1111/bcp.13524",
language = "Ingl{\'e}s estadounidense",
volume = "84",
pages = "1013--1019",
journal = "British Journal of Clinical Pharmacology",
issn = "0306-5251",
number = "5",
}