RNOH R&D Department

RNOH R&D Department Report on academic progress

October 2009

Introduction

The interim report last month (see appendix 1):  Summarised the roles of the Joint Research and Education Committees

 Reported the research projects in progress and in preparation

 Reported a breach in research governance and the audit of projects that it triggered  Reported developments in the provision of MSc courses This report focuses on the progress of the R&D Department towards financial sustainability in the wake of the withdrawal of Culyer funding. At the Board meeting, a verbal update on the deliberations of the Joint Academic Committee, due to meet on Mon 26th Oct, will also be given. Income & Expenditure Estimates

(RNOH element of Joint Academic Plan)

The table shows projected income of £269k in this financial year, of which about £100k is R&D support funding from the Comprehensive Local Research Network – what’s left of our previous £2m annual Culyer income. Of the rest, about £150k is from peer-reviewed grant income and about £20k from commercial studies.

09/10 09/10 09/10 10/11 10/11 10/11

Budget Forecast Variance Budget Forecast Variance

£k £k £k £ £k £k

Income – FEC -600 -269 -331 -600 -600 0 Grant target

Income – NHS -271 0 -271 -500 -500 0

Total Income -871 -269 -602 -1,100 -1,100 0

Direct Expenditure 600 655 -55 800 800 0

Fixed Overheads 271 271 0 300 300 0 allocated to R&D

Total Expenditure 871 926 -55 1,100 1,100 0

Net Surplus / 0 657 -657 0 0 0 Deficit (deficit) (adverse)

The peer-reviewed grant income is encouraging because it comes from mainstream national funding councils; this element will increase next year due to full-year contributions from the MRC-funded PACINO trial, the EPSRC-funded Raman study and, almost certainly, funding from the UK Stem Cell Foundation for the impaction grafting study. The necessary upward trajectory of research income depends on further successful applications to these funders, and this in turn depends on the prompt and efficient delivery of the projects already funded.

Additionally, it is essential in the coming year to achieve some success with funding from the NIHR. As reported last month, several applications to NIHR are in progress, to the Research for Patient Benefit, Applied Research Programme Grant and Health Technology Assessment funding streams, some of which could start to contribute in the next financial year.

The contribution from commercial funding is also likely to increase as we consolidate the research network that allows us to offer a multi-site platform for clinical trials of investigational products, for instance those designed to accelerate fracture healing. Progress has been made this year in incorporating Barnet and Chase Farm in the network; the next targets include Royal Free, Whittington and Watford.

If the Stanmore Clinical Research Centre is successful in its application for Provisional Registration as a Clinical Trials Unit, we will be eligible to apply for funding to develop the unit, which will contribute to the R&D support element of our income. We are hopeful that the registration application will be successful, since a strong bid was made in conjunction with the MRC Clinical Trials Unit, which has a great reputation. If the bid is unsuccessful, we can still continue to include the MRC Clinical Trials Unit itself as co-applicants on grant applications as we have done up to now : many funding bodies will only fund clinical trials that come from a registered CTU.

A call for applications for pump-priming funding from the Special Trustees has now been issued to all RNOH and IOMS staff. Up to £70k is available this year. We have stressed the preference for projects that would generate pilot data for applications for external funding. Staff are encouraged to envision the ultimate grant application – what question it will answer and how that will benefit patients, how much resource it will require and what funding source will be targeted. The bid for ST funding should then be tailored to generate the data that will strengthen that ultimate bid. Applicants are invited to team up with the academic support staff provided through the R&D departmental budget – Musculoskeletal Epidemiologist, Biostatistician, Medical Physicist – as well as the academic centre for orthopaedics and R&D manager. This is a strong, if over-stretched, team whose inclusion as co-applicants in the ultimate grant applications will greatly increase the chances of success. Readiness to team up in this way, rather than trying to keep exclusive ‘ownership’ of bids for funding is one of the key culture changes that need to happen in Stanmore if we are to succeed.

Research Governance

We have had to withdraw R&D approval for the ACTIVE trial and suspend recruitment. This is partly because of inadequate research staff but also partly because of low recruitment and protocol violations, stemming from unwillingness to randomise patients between cell- and non-cell-based treatments. This has the potential to damage our reputation greatly and we would seek the support of the Board in bringing about the required culture change that will stop this from happening. The need for culture change

Clearly the financial viability of the R&D programme in Stanmore depends on a rapid rate of increase in research grant income - specifically the clinical trials elements of research projects. Only carefully crafted proposals, addressing clinically important questions with elegant study designs, proposed by credible, multidisciplinary teams of experienced researchers and senior clinicians stand the remotest chance of attracting funding in today’s climate. Having got our house in order in terms of research management and governance, and having defined our research themes, the rate-limiting step in our development now is the motivation, commitment and time availability of RNOH staff to work with the IOMS and the Trust R&D Department to produce the applications and then, when they are successful, to deliver the studies in a disciplined way, adhering to protocols.

The Board should give a lead in attempting to engender it through supporting the R&D Department . I am asking the Trust Board to support approach of the R&D department in driving through the changes listed below:-

 Acceptance of the need to follow protocols closely, including reliable randomisation o Therefore only sign up for studies the consultant agrees with  Consultant readiness to input personally to the design and conduct of trials o Delegation to trainees is fatal  Team up with clinical colleagues, methodologists and clinical academics to strengthen applicant teams o Individualism is fatal  No studies without adequate funding o Including meaningful contribution to the R&D department budget

David Marsh

RNOH R&D Department APPENDIX 1

Interim Report on academic progress

September 2009

Reminder of roles

The Joint Academic Committee, chaired by Professor Shorvon, meets quarterly and its next meeting is on Monday 26th October. Its role is:

 to oversee both research and educational developments

 to manage the collaboration between the Trust and the Division of Surgery in UCL Medical School

 to monitor the progress of the Joint Academic Plan adopted by the Trust and the IOMS Recovery Plan adopted by the Medical School

 to drive the evolution of the Stanmore campus in the direction of an Academic Health Sciences Centre model

A full report from this committee will be given to the October Trust Board.

The Joint Research Committee, chaired by Professor Marsh, meets monthly. Its last meeting was on the 7th September and the current issues are discussed below. Its role is to develop the research strategy outlined in the Joint Academic Plan, including the seeking of grant income and the development of the research culture on the Stanmore campus. A subgroup of the JRC is the Project Evaluation Panel, led by Iva Hauptmannova the R&D Manager, which meets weekly and deals with the practical research governance details of research in progress and proposed. Multiple ad hoc subgroups, constructed on the Translational Team model, focus on individual projects, creating grant applications, setting up and managing projects.

The Joint Education Committee, chaired by Mr Skinner, was intended to meet monthly but has not done so. Its last meeting was on 22nd July and the current issues are discussed below. Its role is to oversee the development of the MSc courses run on the Stanmore campus. Up to now, it has not considered the courses run by the Education Centre or the provision of undergraduate medical education.

Research Developments

1. Research grant income. The table shows grants running, awarded and in set up, and in preparation. Title/Acronym CI/PI Money Funding Funding Grant Status paid into source amount Duratio VIDEO (vitamin D in knee OA) Keen UCL, RNOH ARC £500,000 5 years Running recharge VIDEO extension Keen UCL, RNOH ARC £199,000 2 years Running recharge VRIC (IT systems for research) Grange RNOH JISC £240,000 1.5 Running years Connective tissue neoplasm Flanagan RNOH Running

Smart Nail (implantable device) Taylor UCL, RNOH EPSRC/MRC/TS £114,872 31 Awarded recharge B months PACINO (cell therapy in Marsh UCL, RNOH MRC - TSCRC £858,497 Awarded nonunion) recharge Raman spectroscopy (bone Goodship UCL EPSRC £1,902,99 4 years Awarded quality) 2 Stem Cells in Impaction Blunn UCL UK Stem Cell Over £1mil 2 years In preparation Grafting NIHR ARPG – Preventing Craggs RNOH and NIHR £2,000,00 3-5 In preparation Pressure ulcers in Spinal Stoke 0 years NIHR ARPG – PreventionNeurotrauma of McGregor RNOH NIHR £2,000,00 3 years In preparation Fragility Fractures 0 Tissue engineering for tennis Grange RNOH NIHR i4i £100,000 1 year In preparation elbow Power Wheel Grange RNOH NIHR i4i £100,000 1 year In preparation

TIPOFF (heparin in hip Marsh UCL Proposed HTA Over £1mil In preparation fractures) ICRS UK (Cartilage Trial) Marsh/Ben UCL Proposed HTA Over £1 In preparation tley mil Research for Patient Benefit – Kalyan RNOH NIHR £250,000 1- 3 In preparation vertebral fractures years Research for Patient Benefit Singh RNOH NIHR £250,000 1-3 In preparation years

2. Research Governance Following a breach of Good Clinical Practice regulations, previously reported to the Trust Board, we were asked to conduct an audit of current studies to ensure there were no further breaches. This has been done and none were found. However, this raised the likelihood of an MHRA inspection and, in order to prepare for this, the Joint Research Committee decided that the CEO, R&D Director and Manger would write to all RNOH staff. The letter was sent out after endorsement by the Exec Directors and is appended herewith. The two key things that must be achieved are that the R&D office must know about, and approve, all ongoing research and that all staff involved in research must have GCP training. Any research involving patients, not notified to the R&D Department by the end of September, will not have R&D approval and will be illegal. Several GCP courses have been run and extra ones are being offered in the week of theatre down time at the beginning of October. 3. Pump-priming funding from the Special Trustees The Special Trustees have agreed to fund research projects, up to £70k this year. They accepted our proposal that the Joint Research Committee would issue the call for proposals, stressing the preference for projects that would generate pilot data for applications for external funding, and make recommendations to the Special Trustees, who would make the final decision as to what to fund.

Education Developments

1. The multidisciplinary MSc in Musculoskeletal Science has offered places to 30 new students in its third year, which starts in October. This includes three senior non-medical staff from the RNOH, funded by the Special Trustees, who will do the course over three years. New FDL (flexible and distance learning) techniques will be deployed to facilitate participation.

2. The new MSc in Trauma and Orthopaedics, which will replace the current Higher Surgical Training programme, is in preparation by a team drawn from the IOMS and the Regional Training Committee. A telephone survey of trainees, conducted by the regional trainees’ representative on the RTC, showed strong support for the development, which is also supported by the Deanery. The course is aimed to begin in Oct 2010 and the plans are in the process of obtaining endorsement from UCL.

Evolution towards an Academic Health Sciences Centre

At a meeting of the CEO, Medical Director and Clinical Professor with Prof David Fish, Managing Director UCL Partners, we made clear our intention to supply the musculoskeletal element to the AHSC. The response was positive and more will be reported on this next month.

David Marsh