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Table 1 Data structure and analysis plan for specific research questions within the ‘Partnerships’ cross-cutting theme

From: Maximising value from a United Kingdom Biomedical Research Centre: study protocol

Research question Methodology First-order data Higher-order data
1. DRUG DEVELOPMENT. How can we improve the efficiency and patient-relevance of early-stage biotechnology drug development? ‘Open-source’ approach to early drug development and testing. Emphasis on knowledge sharing, industry collaborations and efficient harnessing and use of patient capital funds and venture capital Narrative accounts of how drug ‘probes’ were developed, de-risked, linked with investment funding and channelled into Phase I and IIa clinical testing. Cross-case insights into blocks and bottlenecks in this pathway Generalisable insights on how to generate the pipeline, momentum and precedent to ‘unlock’ the potential for new drug and medical device development from excellent basic science and experimental medicine
2. MEDICAL DEVICE DEVELOPMENT. How can we improve the efficiency and patient-relevance of early-stage medical device development? Case-based interdisciplinary approach to device development that brings together clinical entrepreneurs, bioengineers, business experts and social scientists Longitudinal narrative accounts of the unfolding fortunes of a sample of new medical devices and their inventors. Cross-case insights into technical, financial, logistical and regulatory challenges and key training needs
3. BUSINESS DEVELOPMENT AND COMMERCIALISATION. How can we ensure that intellectual property developed as part of NHS-university partnerships is rapidly commercialised and brings prompt benefits to NHS patients? Case-based interdisciplinary research on the fortunes of candidate innovations as they move from an abstract idea to a business case and thence to testing, trialling and scale-up Longitudinal narrative accounts of the organisational, regulatory, political and policy challenges involved in bringing innovations to market (including the process of leveraging capital, growing a value network and tightening the value chain) Generalisable insights on how best to support clinical entrepreneurs and how to select, de-risk and nurture innovative ideas for patient benefit in the NHS setting
4. RESEARCH METHODOLOGY, STATISTICS AND HEALTH ECONOMICS. How can we reduce waste in clinical trials of drugs, medical devices and diagnostics? Methodological, statistical and health economics support for BRC studies from inception to ensure that clinical trials are optimally designed, the right data are collected and the best analytic and reporting methods are used Descriptive statistics on degree of alignment between Oxford BRC’s trials and observational studies and expert standards for methodological and publication quality. Significant events. Generalisable insights on how to improve study design, monitor and refine methodological quality as studies unfold, improve accuracy of economic modelling, and ensure consistent and high-quality reporting in publications
5. PATIENT AND PUBLIC INVOLVEMENT AND ENGAGEMENT (PPI/E) AND ETHICS. How can we achieve responsible research and innovation (reduce misalignments between entrepreneurial and commercial goals and the public good?) Develop more efficient and scalable ways for patients and citizens to prioritise research questions and ways to follow through on such prioritisation exercises Ensure that social accountability is woven into the governance and activities of the BRC through genuine patient and citizen involvement at every level Narrative accounts and evaluations of research prioritisation exercises; follow-up data on James Lind Alliance and similar priority-setting partnerships. Qualitative description and quantitative benchmarking of the BRC’s PPI/E activities Generalisable insights on how to harness patient and citizen involvement in a way that ensures that innovations and research studies are desirable and aligned with the public good, and on how to measure progress towards this goal. Insights into the ethics and practicalities of managing commercial interests in the context of publicly-funded research
6. KNOWLEDGE TRANSLATION. How can we translate the findings from clinical trials rapidly and efficiently into practice? Targeted support for BRC themes by applying the evidence base on ‘T2’ knowledge translation Narrative accounts and evaluations of knowledge translation efforts linked to BRC biomedical themes Generalisable insights that add to the knowledge base on research translation and implementation science
7. EDUCATION AND TRAINING. How can we best support and develop the next generation of researchers? Ongoing training needs analysis and evaluation. Range of established courses, e.g. research design, health economics. Develop new courses, e.g. entrepreneurship, regulation, PPI/E, implementation science Development of new courses; alignment of these with programme needs. Uptake of courses. Retention rates at every stage of early career development. Critical case studies, e.g. significant events Generalisable insights into how to develop and support the development of individual researchers and into how education and training can efficiently and effectively build capacity for research and entrepreneurship
8. RESEARCH ON RESEARCH. What can we learn from the Oxford BRC about how best to support multi-stakeholder health research partnerships? Targeted interview and ethnographic research on selected activities and research studies within the BRC and its linked partners Longitudinal case narratives of particular projects or topics (research on research), incorporating both qualitative and quantitative data and applying relevant theory, e.g. from sociology and/or science and technology studies Formative and summative learning on how to develop individuals, strengthen partnerships and maximise translational efficiency