NEWCASTLE UPON TYNE HOSPITALS NHS FOUNDATION TRUST RESEARCH STRATEGY

Transcription

1 NEWCASTLE UPON TYNE HOSPITALS NHS FOUNDATION TRUST RESEARCH STRATEGY Authors: John Simpson R&D Director Julia Newton Associate Medical Director Research Approved by: R&D executive Joint Research Executive Newcastle Biomedicine Executive 1

2 INTRODUCTION Newcastle has a burgeoning reputation for excellence in clinical research. For example: Newcastle is home to the only NIHR Biomedical Research Centre (BRC) north of Cambridge (dedicated to the study of ageing and chronic diseases); Newcastle also has a NIHR Biomedical Research Unit (BRU, for the study of Lewy Body Dementia); Newcastle upon Tyne Hospitals NHS Foundation Trust (NuTH) participated in more clinical research studies on the NIHR portfolio than any other Trust in England in The Newcastle upon Tyne Hospitals NHS Foundation Trust is committed to further promoting the reputation for excellence in clinical research and the advancement of medicine, through innovation, for several reasons. In particular, these aspirations align closely with NuTH s stated mission to provide patients with the highest quality of healthcare and to be the most prolific and innovative Trust in moving the frontiers of clinical excellence forward for the benefit of people everywhere. resonate with the NIHR s aim to improve the health and wealth of the nation through research. directly support the consolidation and expansion of Newcastle s reputation as a centre of excellence for medical research and innovation. The ultimate aim of our research strategy is to improve the health and care of our patients, and to consolidate Newcastle s position as one of the premier locations for clinical research in the UK. This encompasses the key aim of supporting the retention of NIHR-appointed research facilities in Newcastle (eg the BRC, BRU and the Diagnostic Evidence Cooperative), and actively supporting applications to attract further prestigious research infrastructure. In parallel, the strategy sets out to serve and support a range of key stakeholders, in particular the Faculty of Medical Sciences at Newcastle University, the local clinical research network (LCRN), industrial partners in the biomedical sciences sector, and partners dedicated to the promotion of research and innovation (such as the Academic Health Science Networks, the Northern Health Science Alliance, the Newcastle BRC, the Newcastle BRU, Academic Clinical Directorates within NuTH, partners from primary care, and others). The purpose of this strategy document is to articulate the means by which we propose to enhance and promote research in NuTH, with the clear ultimate focus of improving standards in patient care. A central element of the strategy is that the success of each of 10 core aims (described below) should be quantifiable against pre-defined targets and within a stated time frame. The core aims are viewed as complementary, and it is highly likely that important synergies will emerge if multiple aims are successfully pursued. This strategy document will be reviewed annually. 1. INCREASE THE NUMBER AND QUALITY OF CLINICAL STUDIES LED FROM NEWCASTLE Background. Newcastle makes a substantial contribution to clinical studies on the NIHR portfolio. However the proportion of these led by investigators from Newcastle is relatively small. To reflect and enhance Newcastle s reputation as a leader in translational medicine, our aim is to help increase the number of Newcastle-led studies. Increase the number of Newcastle-led studies on the NIHR portfolio by 10% by the end of

3 A 10% increase in the number of published papers involving patients, and with Newcastle staff as first or last author, in medico-scientific journals rated as 3* or 4* (as judged by metrics used internally as part of preparatory exercises for the Research Excellence Framework (REF) 2013), by the end of A 10% increase in funded grants with NuTH as the lead institution by the end of Complete documented performance reviews of established Academic Clinical Directorates, and provide written summaries/feedback within 30 days. The target would be to perform annual review (with written feedback within 30 days) in at least 90% of Clinical Academic Directorates by the end of INCREASE THE RECRUITMENT OF PATIENTS TO COMMERCIAL STUDIES Background. While Newcastle recruits approximately 14,000 patients per annum to NIHR portfolio studies, only approximately 6% of these are in commercial studies. We aim to increase the emphasis on commercial studies, with a view to accelerating the delivery of new treatments, and with a view to generating research-related income. Increase the number of commercial portfolio studies by 10% by the end of Increase the number of patients entered into commercial portfolio studies by 20% by the end of ESTABLISH A CLEAR, TRANSPARENT AND PROPORTIONAL LIST OF SPONSOR REQUIREMENTS FOR CLINICAL TRIALS SPONSORED BY NuTH Background. With a view to increasing the value-for-money (and thereby competitiveness) of grant applications, and in order to reduce a perceived burden of bureaucracy in preparing grant applications, a framework of proportional sponsor requirements should be established. This should ensure that smaller, less complex clinical trials receive the appropriate level of governance and oversight without being subject to the rigours of large, complex clinical trials (which must retain proportionally greater levels of scrutiny) Develop a policy document outlining the generic requirements for clinical trials of varying numerical and scientific complexity, and make this available on the Research website, by the end of MAINTAIN THE NUMBER OF PATIENTS ENTERED INTO PORTFOLIO STUDIES IN NuTH Background. The considerations in items 1-3 speak to a broader aim of increasing the complexity and quality of research carried out in Newcastle. Recognising the increased per patient workload that this implies, we seek to maintain our current levels of recruitment to portfolio studies Target recruitment to portfolio studies of 14,200 patients per annum. As above, an associated aim is to incorporate a higher proportion of patients in commercial studies within this. 3

4 5. INCREASE HEALTHCARE WORKERS AWARENESS OF, AND ACCESS TO, CLINICAL RESEARCH Background. There is a perception that clinician end-users find the route to carrying out good quality clinical research both obscure and bureaucratic. The intranet information relating specifically to clinical research is currently inadequate. We shall seek to grow a culture of celebrating research success in NuTH, with greater visibility in public spaces, on the intranet, through Twitter feeds, etc. Revise the Research sections of the NuTH and Joint Research Office websites by end Create a 1-2 page factsheet for any clinician wishing to carry out research by the end of Aim for at least 10 hits on the revised Research website per month by the end of Establish well-publicised research clinics to assist aspiring researchers by the end of Aim for at least 3 users of the service per month. Increase the visibility of promotional material relating to research in NuTH, in areas commonly used by NuTH staff, as judged by staff questionnaire, seeking for >75% to say they have noticed more research publicity, by end IMPROVE TRAINING AND WORKING CONDITIONS FOR CLINICAL RESEARCH STAFF Background. The research staff in NuTH have established Newcastle s reputation for delivering more NIHR portfolio studies than any other Trust in the country. However, space devoted to research staff is at a premium in NuTH. Lack of space creates a suboptimal working environment for several research staff and is a hindrance to delivering this strategy. In addition, we recognise that the ambition to grow research complexity/volume is unsustainable without a commensurate increase in the number of skilled research staff. Furthermore we recognise that there are some disincentives to taking up research posts. Among these are short-term fixed contracts for research nurses, a lack of training days, and lack of opportunities to disseminate the findings of work produced by research teams. We aim to address these issues with the intention of making research posts more attractive. Increase space devoted to research by at least 10% of square footage by the end of 2017, to reflect recent increases in research activity, projected increases in research complexity, and increased numbers of research staff. Ensure regular review of staffing requirements when planning new research (with clear identification of funding streams) and aim to increase research staff in NuTH by 10% by 2019, in line with the projected growth of Newcastle-led and portfolio studies, outlined above. Obtain a commitment to provide contractual arrangements for research nurses in line with other nursing staff in NuTH by the end of Fund at least one educational event per delivery team per annum, at which the team can showcase their work, by the end of Establish funds to enable nurses and other members of NuTH research teams to attend conferences relevant to research and its delivery. In the first instance, aim to fund 2 conference visits per delivery team per annum by end 2015, giving priority to staff presenting talks/posters. 4

5 Establish an annual NuTH workshop for non-medical allied health professionals to showcase research and related opportunities, by the end of Increase availability of research secondments/rotations for nursing and other staff by 10% by the end of INCREASE THE INVOLVEMENT OF PATIENTS IN RESEARCH Background. Research questions should be informed, at least in part, by the patients for whom new medical developments are intended. NHS England has recommended that all patients should have the right to participate in clinical research. Provide written information relating to research in NuTH, and the opportunities arising, to 90% of out-patients and 75% of in-patients in NuTH by the end of 2016 Create a patient s research council for the exchange of ideas and information with the patient body. Aim for this group to meet at least 3 times per annum by the end of MAINTAIN A ROBUST GOVERNANCE FRAMEWORK FOR CLINICAL RESEARCH Background. Newcastle has an effective governance team, and has performed well when visited by regulatory authorities such as the MHRA. A distinct challenge, and opportunity, in the coming years revolves around the governance and oversight of biological samples, and linking these to high quality clinical information in a secure fashion that preserves patients rights and anonymity while promoting high quality research. Achieve at least 70% recruitment to time and target as judged against NIHR metrics (the 70-day rule ) by the end of Ensure a position above the national average for recruitment to time and target as measured against Trusts of comparable size, in national reports, by the end of Ensure that the time from receipt of a valid research application to Research approval is less than 15 days for at least 80% of submissions, by the end of Have no critical events in the next MHRA and HTA inspections in relation to the Research Licenses held by NuTH and the University. Deliver a highly efficient archiving system for retention of research data. Within this system, by the end of 2015, we shall perform an annual audit of 100 randomly identified documents (including documents in site files), with the aim of achieving at least 95% retrieval of legible, appropriately completed forms. In the event that an accuracy of less than 95% is achieved, systems will be reviewed and a further 100 documents audited one month later until 95% accuracy is achieved. Monitor retention of samples in accordance with ethics permissions. Within this system, by the end of 2015, we shall perform an annual audit of 100 randomly identified ethics permissions, with the aim of achieving at least 80% conformity with the plans for sample and data retention stated. 5

6 9. DEVELOP RAPID AND SECURE I.T. SYSTEMS AND INCREASE SECURE SHARING OF RESEARCH DATA Background. The enormous volume of research data that requires to be held by NuTH requires an efficient, secure, user-friendly, high capacity I.T. system. We shall strive to maximise the research potential afforded by patients electronic records. In parallel with item 8 above, by the end of 2015, perform an annual audit of 100 randomly selected datasets, aiming for at least 80% accuracy of data entry and 100% security of those data. 10. DEPLOY DEDICATED FUNDING TRANSPARENTLY, TO PROMOTE CLINICAL RESEARCH Background. We seek to grow the research contribution of high potential clinicians by funding time dedicated to the delivery of research. We recognise that this aspiration depends partly on generating more streamlined finance reporting lines. Improve usage of NuTH s Electronic Staff Record (ESR) for recording/reporting staff finances, and map expenditure to activity within assigned delivery teams and specialty teams. The metric for this target will be approved re-design of the Research ESR Structure by the end of Identify new consultant appointments with especially high research potential and provide half time research funding for 2 years, seeking to fund at least 1 such individual per annum, by the end of In all instances, by the end of 2015, where Trust Research/LCRN funds are identified for use in salaries to develop research capacity, we shall define before the post starts, and in written agreement with the appointee proposed markers of success. These will typically equate to delivery of a grant application of sufficient standard that it is approved for sign off by the university/nhs and/or publication of a high quality manuscript(s). Our metric for achievement of this target will be to have documented targets set with researchers, before funding starts, in at least 80% of awards. Deliver 2 rounds of Research Capability Funding (RCF) per annum, using a transparent and accountable peer-reviewed system, by the end of Increase the transparency and efficiency of commercial drug therapy (DT) accounts, by amalgamating the vast numbers of existing, small holding accounts into smaller numbers of pooled resources dedicated to research, and managed within directorates, with oversight from the Research Director/Associate Medical Director for Research. Our metric is to reduce the current number of DT holding accounts in NuTH by 50% by the end of 2015, while retaining the funds in traceable, manageable systems using the Trust s financial ledger. The success of the strategy will be judged against the metrics described above, and quantified in the matrix in the Appendix. A successful target score of >80% will be considered highly satisfactory, >60% will be considered satisfactory. 6