Meeting patient needs through biomedical discovery in an economically and socially sustainable manner requires a holistic approach. Facilitating strong and equitable partnerships between academia, industry and the NHS, along with effective engagement with regulators, has been a major focus of the Academy’s activities and underpins our FORUM. Our ability to connect researchers, research funders and users from across government, academia, industry, the charity sector and the NHS enables us to deliver our aims of: promoting sustainable models of translation; supporting a vibrant innovation ecosystem; and ensuring a strong UK life science industry
- Stratified medicine. Following a successful symposium in October 2012 we published our report, ‘Realising the potential of stratified medicine’ in July 2013. The report was the culmination of a project to facilitate progress in stratified medicine research and development, and implementation of this approach to the delivery of healthcare. The report addressed barriers in clinical and research infrastructure, regulation, pricing and reimbursement. At a stakeholder meeting in November 2013 to discuss implementation of the report’s recommendations, several agents agreed to take actions forward.
- Streamlining research regulation and governance. Throughout 2013-4 we engaged with policy makers and Parliamentarians around the establishment of the Health Research Authority (HRA) in primary legislation. The Academy is represented on the HRA ‘collaboration and steering group’, and an event we hosted in October 2013 provided a valuable opportunity for Fellows and the academic community to feed in directly to the HRA’s future directions and programme of work. The success of the HRA’s feasibility study into central assessment and approval for NHS research, and subsequent funding for full implementation by the Department of Health, constitutes a major impact of our 2011 report ‘A new pathway for the regulation and governance of health research’.
- Ensuring effective regulation of clinical trials. Working with partner organisations, the Academy engaged with the Medicines and Healthcare products Regulatory Agency (MHRA) to successfully inform the UK government’s negotiating position on the European Clinical Trials Regulation, including incorporation of greater risk adaption, with lower risk trials subject to a proportionate reduction in regulatory requirements.
- Use of patient data for medical research. We were actively involved in the debates around the use of patient data in research throughout 2013-4. We held a discussion dinner in November 2013 on ‘Clinical trial data sharing: privacy, ethics and good science’, bringing together experts in clinical trials, ethics and data privacy, as well as patient representatives. We also hosted a workshop in March 2014 around the theme of data ‘safe havens’ to identify the next steps in their development. The outputs of these meetings will feed into ongoing discussions around: the importance of data transparency; need for clarity about who can access patient data for what purpose; and system controls and governance required. Our work will continue to relate closely to the care.data programme and the Government’s proposed amendments to the Care Bill to strengthen the safeguards surrounding access to patient data.
- Horizon scanning to 2025. For the 2014 FORUM Annual Lecture, a panel of speakers was asked to consider the opportunities and challenges facing biomedical research in their sector over the next 10 years. The panel included Sir Gordon Duff FRSE FMedSci (Chairman, MHRA), Professor Sir Malcolm Grant CBE (Chair, NHS England), Professor Dame Nancy Rothwell FRS FMedSci (President and Vice-Chancellor, University of Manchester), and Professor Patrick Vallance FMedSci (President, Pharmaceuticals R&D, GSK). The excellent talks and lively discussion were filmed and made available on our YouTube channel.
- Embedding research in health service. In October 2013 we hosted the Chair of NHS England for a discussion with Fellows on research in the NHS. Our response to the consultation on NHS England’s draft R&D strategy empahsised the need to make research ‘everybody’s business’ and to build a culture that values and promotes research and innovation across the NHS. The Academy is also represented on the Board of NICE Implementation Collaborative, established to support consistent and prompt uptake of NICE guidance.
- Ensuring a sustainable medical science workforce. Highly skilled individuals are UK medical science’s most valuable resource. Throughout 2013-4 we engaged with the learned societies and industry around the skills agenda and continued to stress the importance of facilitating mobility of medical researchers between industry, academia and the healthcare sector in our policy work and at our career development events.
- Following up our report on stratified medicine and ensuring that its conclusions influence the development of policy in the UK and beyond, and have an impact on the awareness and future adoption of this approach to therapy by healthcare professionals.
- Continuing to explore and facilitate new relationships between academia, industry and the healthcare sector in the innovation and development pipeline, particularly through our programme of FORUM events. Engaging patients, practitioners and the NHS in the development, adoption and diffusion of new treatments will be a priority area of work.
- Delivering a four-year follow up meeting on the regulation and governance of health research to see how the landscape has altered since the publication of our report and the next steps required, as well as exploration of new modes of regulation including adaptive licensing. Contributing to the development of UK legislation and secondary EU legislation, as well as the IT infrastructure, to support the implementation of the European Clinical Trials Regulation.
- Engaging with the ongoing discussions around the use of patient data and highlighting the benefits of access to this data by medical researchers.
- Encouraging collaboration and mobility of researchers between sectors and across disciplines by drawing the different groups together at events and through structured networks.