Samantha Cruz Rivera1,2,3, Barbara Torlinska1,2,3, Eliot Marston1, Alastair K Denniston1,2,4,5,6, Kathy Oliver7, Steve Hoare8, Melanie J Calvert9,10,11,12,13,14,15. 1. Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK. 2. Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. 3. Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. 4. Health Data Research, London, UK. 5. University Hospitals Birmingham NHSFT, Birmingham, UK. 6. Regulatory Horizons Council, London, UK. 7. International Brain Tumour Alliance (IBTA), Tadworth, UK. 8. The Association of the British Pharmaceutical Industry, London, UK. 9. Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK. M.Calvert@bham.ac.uk. 10. Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. M.Calvert@bham.ac.uk. 11. Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. M.Calvert@bham.ac.uk. 12. Health Data Research, London, UK. M.Calvert@bham.ac.uk. 13. National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, University of Birmingham, Birmingham, UK. M.Calvert@bham.ac.uk. 14. NIHR Surgical Reconstruction and Microbiology Research Centre, University Hospitals Birmingham NHS Foundation Trust, University of Birmingham, Birmingham, UK. M.Calvert@bham.ac.uk. 15. National Institute for Health Research (NIHR) Applied Research Centre West Midlands, University of Birmingham, Birmingham, UK. M.Calvert@bham.ac.uk.
Abstract
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.
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.
Entities:
Keywords:
Health products; Medicines and devices; Regulatory science
Authors: Matthew S Davenport; Tom Fruscello; Mythreyi Chatfield; Stefanie Weinstein; William F Sensakovic; David B Larson Journal: J Am Coll Radiol Date: 2020-10-21 Impact factor: 5.532