Research Strategy

Transcription

1 V1.3, October 2013 Research Strategy Page 1 of 15

2 CONTENTS Page Executive summary 3 1. Introduction and strategic context 4 2. CCC s current research portfolio 6 3. Research strategic goals GOAL ONE We will continue to support the development of academic oncology 9 GOAL TWO We will increase clinical trial participation 12 GOAL THREE We will continue to develop robust research governance arrangements 13 GOAL FOUR We will build research capability/capacity that enables a seamless transition to a relocated site Risks to strategy delivery A vision for research at CCC in References Writing Committee 15 Page 2 of 15

3 Clatterbridge Cancer Centre NHS Foundation Trust Research Strategy Executive Summary Clatterbridge Cancer Centre (CCC) is the single provider of non surgical oncology in the Merseyside & Cheshire Cancer Network, one of the largest cancer networks in the UK. It offers a full range of services in radiotherapy and systemic anti cancer therapy for all patient groups (except for the systemic therapy of haematological malignancy) and currently has the only operating proton therapy facility in Britain. CCC has strong clinical footprints in the cancer units and specialist trusts in the network and its clinical services are cohesive both on and off the CCC site. The Trust is presently sited away from the University of Liverpool, although there are plans to relocate a significant proportion of its services to central Liverpool, adjacent to the University of Liverpool, by CCC recognises the importance of and remains committed to securing an international reputation for excellence in research. At the heart of this commitment is improving outcomes for our patients. The development of a goal orientated strategy provides clarity regarding CCC s short to medium term research ambitions. CCC is nationally recognised for its contribution to National Institute for Health Research portfolio studies. CCC would benefit from further strengthening its leadership of such research. This strategy articulates the following four goals that will enable a real step change in CCC s research outputs. It will also allow the Trust to develop a longer term vision that meets the changing local and national landscape. CCC s Research Goals GOAL 1: GOAL 2: GOAL 3: GOAL 4: We will continue to support the development of academic oncology We will increase clinical trial participation We will continue to develop robust research governance arrangements We will build research capability/capacity that enables a seamless transition to a relocated site Page 3 of 15

4 1. Introduction and strategic context Research is a central component of the vision of The Clatterbridge Cancer Centre (CCC) to provide the best cancer care to the people we serve. Having a strong portfolio of original research that is internationally competitive is important for many reasons including: NHS organisations that are research active appear to have better overall performance than non research active Trusts. 1 It will enable CCC to deliver high quality patient focused research. It will strengthen CCC s academic partnership with the University of Liverpool. It increases research income. It enables CCC to help lead the way in the cancer treatments of tomorrow. It helps attract and retain high quality staff. It promotes innovation. It enhances organisational and individual reputation. It promotes an evidence based healthcare culture. CCC recognises that having a strong cross cutting research strategy is an integral part of being a leading cancer centre. This document is designed to complement other key strategies, i.e. the National Institute for Health Research (NIHR), Liverpool Health Partners, the University of Liverpool and those of our NHS partners. A number of recent national publications have generated additional challenges to deliver the national ambition for R&D 2,3,4,5,6. CCC supports the NIHR vision to improve the health and wealth of the nation through research and the following strategic objectives: To transform research in the NHS. To increase the volume of applied health research and opportunities to participate in it, for the benefit of patients and the public. To promote and protect the interests of patients and the public in health research. To drive faster translation of basic science discoveries into tangible benefits for patients. To develop and support the people who conduct and contribute to applied health research. To maximise the research potential of the NHS to contribute to the economic growth of the country through the life science industries. Page 4 of 15

5 CCC continues to make a significant contribution to patient recruitment into clinical research programmes, which is nationally recognised. CCC has historically been weaker on the development of locally led research, although significant progress has been made since the recent establishment of the Academic Unit of Oncology. Delivery of this strategy will allow a further stepchange in the Trust s research outputs and enable development of a longer term vision for research. This document will be supported by a number of detailed work plans and performance metrics. Delivery will be overseen by the Research Committee and progress reported to the Trust Board six monthly. Page 5 of 15

6 2. CCC s current research portfolio CCC s current research portfolio includes: A growing portfolio of locally led research. A portfolio of National Institute for Health Research studies (Phase II III). Pharmaceutical commercially sponsored clinical trials (Phase I III). The Liverpool Early Drug Development Unit (Translational research and Phase I/II trials). Figure 1 Key work streams and strategic partnerships. Research at Clatterbridge Cancer Centre Strategic Partnerships Academic Medical Oncology Academic Radiation Oncology Liverpool Health Partners LEDDU Translational Research and Phase I trials CRUK Centre - Liverpool NIHR NWCCRN Phase II and III trials CRUK Liverpool Cancer Trials Unit Cancer patients, relatives and carers Page 6 of 15

7 There is a growing portfolio of locally led academic research at CCC. CCC has innovative radiotherapy physics and radiobiological modelling studies, which have now progressed in terms of local implementation and national recognition. A number of academic and NHS clinicians are leading research in radiotherapy, systemic therapy, supportive care and nursing related issues. The development of such research programmes is resource intensive and requires a supportive research culture in order to flourish. CCC has successfully hosted the Merseyside and Cheshire Cancer Research Network (MCCRN) since its inception in Due to changes in the national configuration of clinical research networks the MCCRN will be hosted by the Royal Liverpool and Broadgreen University Hospitals NHS Trusts from 1 st April The aim of the research network is to provide the cancer network with an infrastructure to support randomised prospective trials of cancer treatment. These include surgery, radiotherapy, chemotherapy, palliative care, newer treatment modalities and other welldesigned studies that form part of the National Institute for Health Research (NIHR) portfolio. The purpose of the MCCRN is to benefit patients by improving the integration, quality and speed of cancer research. Patient recruitment to the NIHR portfolio studies has progressed from 4.8% in 2001/2 to 23% in 2012/13. CCC also has a growing portfolio of industry sponsored research. This provides clinicians and patients with access to novel agents, which present an additional treatment option. portfolio. Commercial research currently accounts for circa 30% of CCC s research Figure 2 Proportion of interventional studies currently open at CCC. Page 7 of 15

8 The Liverpool Early Drug Development Unit (LEDDU) is a collaboration between CCC, The Royal Liverpool Hospital and the University of Liverpool. The aim of the LEDDU is to provide the bridge between scientific research and clinical practice. The LEDDU has enabled the development of a portfolio of phase I trials at both CCC and the Royal Liverpool Hospital. Currently 13% of studies open at CCC are phase I or phase I/II. Underpinning these work streams are robust research governance arrangements. The Trust has an agreed three year research governance strategy and associated annual work plan. A comprehensive range of research governance policies and standard operating procedures (SOPs) have been developed. We provide internal and external training on the Clinical Trials Regulations (2004) and Good Clinical Practice (GCP). We have introduced the Edge system at CCC to provide a an integrated electronic database to map the CCC research portfolio, monitor activity, produce output reports, streamline the trial set up processes and facilitate compliance with legislation. We have also introduced a new financial management system designed to proactively manage research income and enable internal re distribution of funds. With further development this will allow the R&D Directorate to function as an externally funded business unit. Page 8 of 15

9 3. Research strategic goals GOAL ONE We will continue to support the development of academic oncology CCC will play a leadership role in the future development of academic oncology. CCC has invested heavily in the Academic Unit of Oncology and sees it as an excellent opportunity to strengthen its relationship with the University of Liverpool and to increase the volume of internationallycompetitive research led by CCC. The Academic Unit is led by Professor Daniel Palmer (Chair of Medical Oncology) and will serve to increase grant income from the NIHR and its partners. Having a strong portfolio of original research is a core function of a leading cancer centre. We will strive to improve our research performance and the quality of our research outputs. CCC recognises that delivery of this goal will enhance its reputation and lead to greater strategic and financial rewards. To achieve this goal we will: Establish a CCC/UoL Academic Board to oversee the strategic development of academic oncology. The Academic Board will ensure that a strategy is developed for each disease focus area as outlined below: Disease Focus Area Hepatobiliary and pancreas Lead: Professor Dan Palmer Scientific Focus Areas Develop biomarkers for early diagnosis and monitoring of hepatocellular and biliary cancers and for chemotherapyinduced liver injury using sera from the CCC biobank and in collaboration with LHP partners. Expand the early phase clinical trial programme for HPB malignancies to include novel immunotherapies in partnership with academic collaborators, commercial partners and from the Academic Oncology Unit laboratories, UoL. Increase recruitment to, and leadership of, HPB phase III NCRN portfolio and commercial trials. Page 9 of 15

10 Breast Lead: Professor Carlo Palmieri Develop of Phase II, III clinical trials as well as well as translational research. Both these will involve working with collaborators in academia and industry. Establishment of a metastatic breast cancer database Development of cross cutting research across specialities in Liverpool Bladder Lead: Dr Syed Hussain Prostate Lead: Dr Isabel Syndikus Gynaecology Lead: Dr Rosie Lord Ocular Melanoma Lead: Dr Ernie Marshall Head and Neck Lead: TBA Lung Lead: TBA Raising awareness of breast cancer locally and increasing screening rates Develop early phase (phase I/II) and late phase (phase III) trials with linked translational research. Development of academic and industrial partnerships. Strengthen the participation in trials for localised and metastatic disease. Develop early phase (phase I/II) and late phase (phase III) trials with linked translational research. Development of academic and industrial partnerships. Strengthen the participation in trials for localised and metastatic disease, support relevant NCRI studies, develop a new randomised multicentre trial including dose painting radiotherapy; recruit patients to the LTCU led BIOPROP20 trial. Develop early phase trials and translational research in partnership with the academic unit and industry partners. Strengthen existing collaborations with the Endometrial Cancer Group and Head and Neck HPV Group (cervix) University of Liverpool. Metastatic screening, phase I/II/III drug trials, translational research Develop early phase (phase I/II) and late phase (phase III) trials with linked translational research. Development of academic and industrial partnerships. Implementation of modern radiotherapy technology combined with novel dose escalation strategies in Phase II/III trials to improve results in locally advanced NSCLC. Maintain active membership of the Liverpool Health Partners Board. Support the Cancer Research UK Centre Liverpool agenda through the centre s Governance Board. Page 10 of 15

11 Contribute to the work of relevant academic committees, e.g. the Joint Research Office and LEDDU Management Committee. Work with the Joint Research Office at the University of Liverpool to streamline sponsorship arrangements for joint projects, i.e. projects involving a CCC employee and utilising UoL services. Work with the North West Coast Clinical Research Network to secure the National Institute for Health Research infrastructure required to support the outputs of the Academic Unit of Oncology. Establish a CCC Biobank which will store blood, plasma, cellular material and urine. The Biobank will facilitate research into the molecular mechanisms of cancer / biomarker discovery for early detection of cancer and will be accessible to local and national collaborators. It is envisaged that the CCC Biobank will join the NCRI Confederation of Biobanks further enhancing CCC s reputation. Establish a forum for Chief Investigators to stimulate new research ideas some of which will be cross cutting. Direct support to those staff that are capable of delivering high quality, relevant clinical research. Support the development of centralised joint trials clinics to maximise efficiency, skills and cross cover. Support medical consultants who generate significant research outputs by providing them with protected research time. Offer a Clinical Research Fellowship programme that attracts high quality trainees in both medical and radiation oncology. Work with the Liverpool Cancer Trials Unit (LCTU) to increase grant income from the NIHR and its partners. The LCTU will continue to be our preferred provider of trial management expertise. Work with the Clatterbridge Cancer Charity to provide funding for early/novel research projects that are not ready for established national funding routes. Provide an Intellectual Property (IP) framework that encourages innovation; protects and exploits IP (as described in CCC s Intellectual Property Policy). Our researchers will aim to publish in high quality scientific journals. We will maintain a publications repository to showcase these research outputs. We will also ensure patients are signposted to the results of research carried out at CCC. Page 11 of 15

12 GOAL TWO We will increase clinical trial participation The National Institute for Health Research Cancer Research Network is a target driven organisation with the primary aim to increase the number of cancer patients entered into NIHR studies to 10%. A secondary objective is to increase recruitment into randomised controlled trials (RCTs) to 7.5%. In Merseyside and Cheshire patient recruitment has progressed from 4.8% in 2001/2 to 23% in 2012/13 (7.5% Randomised Control Trials). CCC has a broad local portfolio of NIHR and industry sponsored studies across a range of cancers. CCC recognises the importance of making patients aware of research that is relevant to them and maximising patient choice. CCC clinicians actively recruit patients into clinical trials at its satellite clinics in nine local NHS Trusts. We will work with the North West Coast Clinical Research Network (NWCCRN) and local NHS partners to increase recruitment into high quality, phase I III clinical commercial and non commercial oncology trials. To achieve this goal we will: Work with the NWCCRN to provide the infrastructure to support patient recruitment into clinical trials. Increase the proportion of studies in the NIHR portfolio delivering to recruitment time and target (in line with national target of 80%). Improve public awareness that CCC is a research active organisation by: o Ensuring that information about research is provided to every patient referred to CCC. o We will display posters in public areas informing people that we are a research active organisation. o We will run regular research awareness days to inform patients, visitors and staff about clinical research. o We will ensure that patients have an opportunity to provide feedback about research through the patient satisfaction survey. We will use this feedback to further improve our service. o We will increase research awareness in the units/mdts of all studies in the network and develop local research champions Page 12 of 15

13 We will establish a quarterly Portfolio Performance Management Committee to performance manage our recruitment to ensure that we are maximising the use of resources and meeting national targets. GOAL THREE We will continue to develop robust research governance arrangements Research Governance is a broad range of legal and regulatory requirements, guidelines and principles that exist to ensure health and social care research is conducted to the highest possible scientific and ethical standards. Our quality assurance framework will be further developed to ensure that CCC meets all research regulatory requirements. To achieve this goal we will: Develop a three year research governance strategy that is reviewed annually to ensure it is responsive to changes in legislation. Have a Research Governance Committee that meets quarterly to oversee that agenda. Have an annual governance work plan ratified by the Research Governance Committee. Maintain a comprehensive portfolio of research specific standard operating procedures (SOPs). A review process will be developed to ensure that SOPs are current and meet the national research support services framework requirements. Develop agreements to ensure optimal governance arrangements for cross Trust initiatives, i.e. the development of trial specific sub contracts. Ensure that training is made available to all research staff regarding changes in regulatory requirements. Ensure we have a plan for the ongoing monitoring of research studies. Audit our Trust permission process annually and benchmark our review times against expected standards. Work with the Joint Research Office (JRO) to streamline sponsorship process for joint projects. Develop a robust financial management system to enable R&D to function as an externally funded business unit. Page 13 of 15

14 GOAL FOUR We will build research capability/capacity that enables a seamless transition to a relocated site The Transforming Cancer Care Project aims to relocate a significant proportion of CCC s facilities to an acute hospital site within the next five years. A business case is under development to demonstrate the benefits and affordability of placing a hub of CCC s services adjacent to a redeveloped Royal Liverpool Hospital and the University of Liverpool on a campus that will provide significant beneficial clinical and research synergies. To this end CCC will work with its local NHS and academic partners to develop a longer term vision for cancer research in Merseyside and Cheshire. This will inform business plans and support the relocation business case. To achieve this goal we will: Map the current gaps in our research capability and establish those that can be addressed in a virtual way and those that can only be solved by relocation. Develop the research staff skill mix and expanded role of Research Practitioners. Ensure that research is represented in all departmental clinical service design briefs. This will facilitate the integration of research into core Trust business. Develop longer term strategic goals that reflect Trust s overarching strategic direction and fit with local and national priorities. 4. Risks to strategy delivery In order to realise these goals the Trust recognises that progress is subject to: The full participation of other organisations, i.e., University of Liverpool, the NWCCRN, commercial sector etc. Changes in external policy including a change in Government. Unforeseen financial constraints by key stakeholders. Delivery of the strategy is reliant on continued investment and support. Recruitment and retention of people capable of producing internationally competitive research (with the protected time to execute this role). Any risks to the delivery of this strategy will be reported through the Trust s risk management process and escalated as appropriate. Page 14 of 15

15 5. A vision for research at CCC in 2017 In summary, the successful delivery of this research strategy will ensure that by 2017: CCC has a research environment that is dynamic and responsive to changing local and national priorities. CCC, its local NHS partners and the University of Liverpool will have a cohesive relationship. CCC s reputation for the development and delivery of research will be internationally recognised. 6. References 1. Being a good research partner: the virtues and rewards. NHS Confederation. Briefing October 2010, issue Strategy for UK Life Sciences. Office for Life Sciences, Improving Outcomes: a strategy for cancer. Department of Health, The NHS Constitution. Department of Health, The Handbook to the NHS Constitution. Department of Health, A Brief Overview of the NIHR. National Institute for Health Research, Strategy Writing Committee: Mrs Jenny Almond Professor Michael Brada Professor Philip Johnson Dr Peter Kirkbride Dr Rosie Lord Dr Maria Maguire Dr Ernie Marshall Professor Alan Nahum Professor Dan Palmer Professor Carlo Palmieri Dr Isabel Syndikus Director of Research CCC NHS FT Chair of Radiation Oncology Chair of Translational Oncology Medical Director Chemotherapy Research Lead Research Manager MCCRN Clinical Lead Head of Physics Research Chair of Medical Oncology Chair of Translational Oncology Radiotherapy Research Lead Page 15 of 15