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.
|Journal||Therapeutic Innovation & Regulatory Science (SPRINGER)|
|Early online date||16 Feb 2021|
|Publication status||E-pub ahead of print - 16 Feb 2021|
Bibliographical noteFunding Information:
Although the survey was anonymous, some respondents agreed for their names to be listed. We would like to thank the following individuals for completing the online survey: Adrian Jonas, The National Institute for Health and Care Excellence (NICE); Prof Alastair K Denniston, University Hospitals Birmingham NHSFT and University of Birmingham; Alice Turnbull, National Programme Director, Better Care, HDR UK; Amanda Hunn, Director A J Hunn Associates; Arsenio Paez IDEAL Collaboration, University of Oxford, Oxford, UK; Ben Jacoby, Director, Cambridge-RA Ltd; Prof Bryan Morton CBE, Entrepreneur; Christopher Kelly, Google Health, London; Health Research Authority; Diana Rofail, PhD CPsychol MBA Head of Patient-Centred Outcomes, Regeneron; Deborah Morrison, Principal Scientific Adviser, The National Institute for Health and Care Excellence (NICE) Scientific Advice; Elaine Manna, Patient at Moorfields Eye Hospital; Gary Price, PPIE lead, Centre for Patient Reported Outcomes Research (CPROR); Dr Hugh Harvey, MBBS BSc(hons) FRCR MD(Res) FBIR and Managing Director, Hardian Health; Jacqui Gath, ICPV; Jeremy Wyatt, Emeritus Professor of Digital Healthcare, University of Southampton; James Pink, Senior Director NSF Health Sciences; Prof James S. Wolffsohn, Aston University, Birmingham, UK; Jessica Roydhouse, Select Foundation Senior Research Fellow in Health Services Research; Joseph C. Cappelleri, Pfizer Inc.; Joanne Holden, Associate Director, Centre for Health Technology Evaluation, The National Institute for Health and Care Excellence (NICE); Kathy Oliver, Chair and Co-Director, International Brain Tumour Alliance (IBTA); Kim Wharton, Managing Director, Regulis Consulting; Michael Pogose BEng (Hons) MSc CEng MIET MAPM SenNoSen Ltd; Dr Marcus Ong, Spectra Analytics; Dr Patrick Ginty, Head of Regulatory Affairs, Cell and Gene Therapy Catapult; Pearse A Keane, Consultant Ophthalmologist, Moorfields Eye Hospital NHS Foundation Trust Associate Professor and University College London (UCL) Institute of Ophthalmology; Prof Pete Wall, Clinical Director, Isca Healthcare Research Limited; Phil Collins, Patient Advocate; Richard Stephens, Patient Advocate; Rob Turpin, Head of Sector, BSI Knowledge Solutions; Roger Wilson, Patient Advocate; Prof Ruth Roberts, ApconiX, UK and The University of Birmingham; Simon Oakley; Sophie C. Cox, Healthcare Technologies Institutes; Steve Hoare, Association of the British Pharmaceutical Industry (ABPI); Menzies Institute of Medical Research and University of Tasmania; Vishal Bhatnagar, Oncology Centre of Excellence, US, FDA; Xiaoxuan Liu, University Hospitals Birmingham NHS Foundation Trust. We also thank all the individuals who agreed to participate in the online survey and prefer to remain anonymous.
This work was supported by a Quality-related Research (QR) grant from Research England.
© 2021, The Author(s).
- Health products
- Medicines and devices
- Regulatory science
ASJC Scopus subject areas
- Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
- Public Health, Environmental and Occupational Health
- Pharmacology (medical)