Regulatory and health technology assessment advice on postlicensing and postlaunch evidence generation is a foundation for lifecycle data collection for medicines

Autor: Agnese Cangini, Maren Koban, Leonor Varela Lema, Spiros Vamvakas, Deborah Morrison, Sonia Garcia, Solange Corriol-Rohou, Emmanuel Gimenez Garcia, Anders Viberg, Piia Rannanheimo, Muriel Pasté, Alison Cave, Catherine Cohet, Peter Arlett, Xavier Kurz, Susan Sandler, Mercè Obach, Amr Makady, Hanna-Mari Jauhonen, Michael Berntgen, Virginia Acha, Emma Du Four, Jane Moseley, Karin Van Baelen, Chantal Guilhaume, Anja Langeneckert, Anna Strömgren, Marc Van De Casteele, Christelle Lamoril, Simon Bennett
Rok vydání: 2020
Předmět:
Zdroj: British Journal of Clinical Pharmacology
ISSN: 1365-2125
0306-5251
DOI: 10.1111/bcp.14279
Popis: The understanding of the benefit risk profile, and relative effectiveness of a new medicinal product, are initially established in a circumscribed patient population through clinical trials. There may be uncertainties associated with the new medicinal product that cannot be, or do not need to be resolved before launch. Postlicensing or postlaunch evidence generation (PLEG) is a term for evidence generated after the licensure or launch of a medicinal product to address these remaining uncertainties. PLEG is thus part of the continuum of evidence development for a medicinal product, complementing earlier evidence, facilitating further elucidation of a product's benefit/risk profile, value proposition, and/or exploring broader aspects of disease management and provision of healthcare. PLEG plays a role in regulatory decision making, not only in the European Union but also in other jurisdictions including the USA and Japan. PLEG is also relevant for downstream decision-making by health technology assessment bodies and payers. PLEG comprises studies of different designs, based on data collected in observational or experimental settings. Experience to date in the European Union has indicated a need for improvements in PLEG. Improvements in design and research efficiency of PLEG could be addressed through more systematic pursuance of Scientific Advice on PLEG with single or multiple decision makers. To date, limited information has been available on the rationale, process or timing for seeking PLEG advice from regulators or health technology assessment bodies. This article sets out to address these issues and to encourage further uptake of PLEG advice. ispartof: British Journal Of Clinical Pharmacology vol:86 issue:6 pages:1034-1051 ispartof: location:England status: Published online
Databáze: OpenAIRE
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