Building HTA insights into the drug development plan: Current approaches to seeking early scientific advice from HTA agencies.

Autor: Wang T; Centre for Innovation in Regulatory Science (CIRS), London, UK; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands. Electronic address: twang@cirsci.org., McAuslane N; Centre for Innovation in Regulatory Science (CIRS), London, UK., Gardarsdottir H; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands., Goettsch WG; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands; National Health Care Institute, Diemen, the Netherlands., Leufkens HGM; Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, the Netherlands.
Jazyk: angličtina
Zdroj: Drug discovery today [Drug Discov Today] 2022 Jan; Vol. 27 (1), pp. 347-353. Date of Electronic Publication: 2021 Sep 28.
DOI: 10.1016/j.drudis.2021.09.014
Abstrakt: There is a growing trend for pharmaceutical companies to seek scientific advice on drug development from a Health Technology Assessment (HTA) perspective, to improve the efficiency of their studies, enable better trial design, and support the goals of positive HTA recommendation for reimbursement. This study uses information collected directly from companies on individual products to assess their strategies and practices for seeking HTA-related scientific advice in terms of which stakeholders to engage and for what purpose, when to seek scientific advice, and whether to implement that advice within global clinical development.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2021 Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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