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Regenerative medicine and its development and implementation: Fieldwork interviews
Creator
Webster, A, University of York
Study number / PID
852913 (UKDA)
10.5255/UKDA-SN-852913 (DOI)
Data access
Restricted
Series
Not available
Abstract
The data set is made up of all fieldwork interviews from the 'REGenableMED' project - 72 interviews in four discrete folders. Data was generated in the UK with key research scientists, clinicians, regulators, and companies working in the cell therapy field.
The main research aims that drove the project were as follows: (1) explore emerging sub-sectors of regenerative medicine in the UK, and determine how they vary according to business, clinical and regulatory models; (2) map the value creation process across the key sub-sectors and technologies identified in the Strategy for UK Regenerative Medicine; (3) derive value chain and innovation ecosystem models that will provide a better understanding of pathways to commercial development and clinical application, and the key enablers and constraints; (4) provide a forward look (via horizon scanning and diffusion studies) in respect to the social and organisational challenges that the application of regenerative medicine is likely to create, while at the same time considering how RM will need to respond to changes in the organisation and delivery of healthcare itself; (5) provide a detailed analysis across all important areas of activity, of how the field of RM is likely to evolve in the UK, what factors will constrain its future development, and how innovation can be supported to enable delivery of societal and commercial benefits; (6) to advance interdisciplinary social science methodology by furthering the integration of clinical translation and adoption/diffusion studies with value systems approaches, including qualitative and quantitative methods. REGenableMED is an ESRC-funded project examining the dynamics of innovation within the field of regenerative medicine. Using a mixed-methods social science approach, the project undertakes a detailed analysis of the interplay between business models, measures of clinical utility, patterns of regulatory oversight and clinical workflows within healthcare settings. The...
Terminology used is generally based on DDI controlled vocabularies: Time Method, Analysis Unit, Sampling Procedure and Mode of Collection, available at CESSDA Vocabulary Service.
Methodology
Data collection period
01/03/2015 - 31/03/2017
Country
United Kingdom
Time dimension
Not available
Analysis unit
Individual
Organization
Universe
Not available
Sampling procedure
Not available
Kind of data
Audio
Data collection mode
72 in depth (average 1 hr) interviews with individuals working within the field from across the UK in different institutional settings were undertaken, including those based in research labs, teaching hospitals, companies, patient and professional bodies and government agencies. Our respondents were clinicians developing RM products and procedures that are in, or are about to begin, clinical trials; scientists working within academic networks tasked with identifying and overcoming technical, manufacturing and safety translational challenges; patient association representatives; representatives and members of trade and professional organisations with involvement in RM; representatives from regulatory agencies and other national health governance structures and organisations; and representatives from companies with an interest in RM. Interviews were anonymised, transcribed and subjected to thematic analysis using NVivo 10 software. Interview data were supplemented by RM secondary data: publicly-available committee reports and meeting minutes, company annual reports, and media coverage. Field notes of several RM-industry conferences and workshops that project members attended were drawn on as were webpages, annual reports and other official publications, and publicly available reports and minutes of other international (notably regulatory and legal) agencies working in the area.In addition, a series of in-depth Case Studies of 10 SMES was undertaken spread over 18 months to follow the development of cell therapy products.Horizon scanning techniques were used to map the core networks working in the field. The 700-item (ACCESS) international database was prepared through accessing company reports, clinical trials sources, patent information sources, and publicly available industrial commentaries.Ethics approval for the data collection activities was obtained from the relevant institutional ethics committees, and informed consent was obtained from all participants.
Funding information
Grant number
ES/L002779/1
Access
Publisher
UK Data Service
Publication year
2017
Terms of data access
The Data Collection is available for download to users registered with the UK Data Service. All requests are subject to the permission of the data owner or his/her nominee. Please email the contact person for this data collections to request permission to access the data, explaining your reason for wanting access to do the data. Once permission is obtained, please forward this to the ReShare administrator.