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Advancing UK Regulatory Science Strategy in the Context of Global Regulation: a Stakeholder Survey

BACKGROUND: The UK’s transition from the European Union creates both an urgent need and key opportunity for the UK and its global collaborators to consider new approaches to the regulation of emerging technologies, underpinned by regulatory science. This survey aimed to identify the most accurate de...

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Autores principales: Cruz Rivera, Samantha, Torlinska, Barbara, Marston, Eliot, Denniston, Alastair K., Oliver, Kathy, Hoare, Steve, Calvert, Melanie J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7885762/
https://www.ncbi.nlm.nih.gov/pubmed/33591566
http://dx.doi.org/10.1007/s43441-021-00263-2
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author Cruz Rivera, Samantha
Torlinska, Barbara
Marston, Eliot
Denniston, Alastair K.
Oliver, Kathy
Hoare, Steve
Calvert, Melanie J.
author_facet Cruz Rivera, Samantha
Torlinska, Barbara
Marston, Eliot
Denniston, Alastair K.
Oliver, Kathy
Hoare, Steve
Calvert, Melanie J.
author_sort Cruz Rivera, Samantha
collection PubMed
description BACKGROUND: The UK’s transition from the European Union creates both an urgent need and key opportunity for the UK and its global collaborators to consider new approaches to the regulation of emerging technologies, underpinned by regulatory science. This survey aimed to identify the most accurate definition of regulatory science, to define strategic areas of the regulation of healthcare innovation which can be informed through regulatory science and to explore the training and infrastructure needed to advance UK and international regulatory science. METHODS: A survey was distributed to UK healthcare professionals, academics, patients, health technology assessment agencies, ethicists and trade associations, as well as international regulators, pharmaceutical companies and small or medium enterprises which have expertise in regulatory science and in developing or applying regulation in healthcare. Subsequently, a descriptive quantitative analyses of survey results and directed thematic analysis of free-text comments were applied. RESULTS: Priority areas for UK regulatory science identified by 145 participants included the following: flexibility: the capability of regulations to adapt to novel products and target patient outcomes; co-development: collaboration across sectors, e.g. patients, manufacturers, regulators, and educators working together to develop appropriate training for novel product deployment; responsiveness: the preparation of frameworks which enable timely innovation required by emerging events; speed: the rate at which new products can reach the market; reimbursement: developing effective tools to track and evaluate outcomes for “pay for performance” products; and education and professional development. CONCLUSIONS: The UK has a time-critical opportunity to establish its national and international strategy for regulatory science leadership by harnessing broader academic input, developing strategic cross-sector collaborations, incorporating patients’ experiences and perspectives, and investing in a skilled workforce. SUPPLEMENTARY INFORMATION: The online version of this article (10.1007/s43441-021-00263-2) contains supplementary material, which is available to authorised users.
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spelling pubmed-78857622021-02-16 Advancing UK Regulatory Science Strategy in the Context of Global Regulation: a Stakeholder Survey Cruz Rivera, Samantha Torlinska, Barbara Marston, Eliot Denniston, Alastair K. Oliver, Kathy Hoare, Steve Calvert, Melanie J. Ther Innov Regul Sci Original Research BACKGROUND: The UK’s transition from the European Union creates both an urgent need and key opportunity for the UK and its global collaborators to consider new approaches to the regulation of emerging technologies, underpinned by regulatory science. This survey aimed to identify the most accurate definition of regulatory science, to define strategic areas of the regulation of healthcare innovation which can be informed through regulatory science and to explore the training and infrastructure needed to advance UK and international regulatory science. METHODS: A survey was distributed to UK healthcare professionals, academics, patients, health technology assessment agencies, ethicists and trade associations, as well as international regulators, pharmaceutical companies and small or medium enterprises which have expertise in regulatory science and in developing or applying regulation in healthcare. Subsequently, a descriptive quantitative analyses of survey results and directed thematic analysis of free-text comments were applied. RESULTS: Priority areas for UK regulatory science identified by 145 participants included the following: flexibility: the capability of regulations to adapt to novel products and target patient outcomes; co-development: collaboration across sectors, e.g. patients, manufacturers, regulators, and educators working together to develop appropriate training for novel product deployment; responsiveness: the preparation of frameworks which enable timely innovation required by emerging events; speed: the rate at which new products can reach the market; reimbursement: developing effective tools to track and evaluate outcomes for “pay for performance” products; and education and professional development. CONCLUSIONS: The UK has a time-critical opportunity to establish its national and international strategy for regulatory science leadership by harnessing broader academic input, developing strategic cross-sector collaborations, incorporating patients’ experiences and perspectives, and investing in a skilled workforce. SUPPLEMENTARY INFORMATION: The online version of this article (10.1007/s43441-021-00263-2) contains supplementary material, which is available to authorised users. Springer International Publishing 2021-02-16 2021 /pmc/articles/PMC7885762/ /pubmed/33591566 http://dx.doi.org/10.1007/s43441-021-00263-2 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) .
spellingShingle Original Research
Cruz Rivera, Samantha
Torlinska, Barbara
Marston, Eliot
Denniston, Alastair K.
Oliver, Kathy
Hoare, Steve
Calvert, Melanie J.
Advancing UK Regulatory Science Strategy in the Context of Global Regulation: a Stakeholder Survey
title Advancing UK Regulatory Science Strategy in the Context of Global Regulation: a Stakeholder Survey
title_full Advancing UK Regulatory Science Strategy in the Context of Global Regulation: a Stakeholder Survey
title_fullStr Advancing UK Regulatory Science Strategy in the Context of Global Regulation: a Stakeholder Survey
title_full_unstemmed Advancing UK Regulatory Science Strategy in the Context of Global Regulation: a Stakeholder Survey
title_short Advancing UK Regulatory Science Strategy in the Context of Global Regulation: a Stakeholder Survey
title_sort advancing uk regulatory science strategy in the context of global regulation: a stakeholder survey
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7885762/
https://www.ncbi.nlm.nih.gov/pubmed/33591566
http://dx.doi.org/10.1007/s43441-021-00263-2
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