BOARD OF DIRECTORS 25 OCTOBER 2013

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1 AGENDA ITEM: 1.7 TITLE: BOARD OF DIRECTORS 25 OCTOBER 213 RESEARCH & DEVELOPMENT ANNUAL REPORT PURPOSE: Discussion Please tick Approval Information RECOMMENDATION: The Board of Directors is asked to note the research activity that took place during 212/13. PREPARED BY: DR GWYN MCCREANOR ASSOCIATE MEDICAL DIRECTOR Clinical Lead for Research PRESENTED BY: DR GWYN MCCREANOR ASSOCIATE MEDICAL DIRECTOR CQC OUTCOME: (specify standard) FINANCIAL IMPLICATIONS: Specify No/Yes (Detailed within the report). LINK TO THE BAF AND CORPORATE RISK REGISTER: Please state which risk register this applies to STRATEGIC OBJECTIVE: (specify objective) FREEDOM OF INFORMATION EXCEPTION: (if applicable) NHS CONSTITUTION: EXECUTIVE SUMMARY: Outcome 4 and 7 Potential through reconfiguration of service and environments Excellent Quality N/A In determining this matter, the Board should have regard to the Core principles contained in the Constitution of: Equality of treatment and access to services High Standards of excellence and professionalism Service user preferences Cross community working Best Value Accountability through local influence and scrutiny The Annual Report for Research & Development is presented to the Board to provide an overview of the research activity undertaken during 212/13.

2 Research and Development Annual Report: 1 April 212 to 31 March 213 This report provides a summary of the research activity within the Kettering General Hospital NHS Foundation Trust (KGH) in the 212/13 financial year. Research Portfolio The Research Portfolio consists of a mixture of National Institute of Health Research (NIHR) portfolio studies and studies that have not been adopted onto the NIHR portfolio. In 212/13, KGH was involved in conducting a total of 79 clinical research studies. The NIHR portfolio studies accounted for 8% of the Trust research portfolio (63 studies). The remaining 2% (16) of studies included three commercial studies and a number of own account, student research projects, CLAHRC and multicentre studies. In addition, there were 22 studies closed to recruitment with patients in follow-up during the year. Figure 1 shows the distribution of research studies across the Trust by speciality. Figure 1: Number of studies open to recruitment by speciality, 212/213 (n= =79) Non-portfolio NIHR Portfolio

3 New studies New studies must go through ethics and Trust approval processes including information governance and financial considerations. Thirty new research studies were approved and opened for recruitment across 15 specialities in 212/13. Patient Recruitment Total patient recruitment to research studies in 212/13 was 3,177, with 1,25 recruited to NIHR portfolio studies and 2,152 to non-portfolio studies. Overall this is an increasee of 34% over 211/12 when total patient recruitment to research studies reached 2,19, (1,11 recruited to NIHR portfolio studies and 1,8 to non-portfolioo studies). A significant contributor to this years recruitment was the continued success of a non-portfolio National Initiative NHS Breast Screening Programme with 2,45 patients recruited. Figure 2 presents a breakdown of patient recruitment across speciality and Figure 3 presents the recruitment data for NIHR portfolio studies only. Figure 2: Recruitment to research studies by speciality 212/213 (n=3,177) 25 Non-portfolio NIHR Portfolio

4 Figure 3: Recruitment to NIHR portfolio studies by speciality 212/213 (n=1,25) 25 NIHR Portfolio Figure 4 provides a cumulative monthly breakdown of reported participant recruitment to NIHR portfolio studies for the period against the 212/13 target and presents the recruitment achieved over the previous four years. Figure 4: Recruitment to NIHR portfolio studies, 28/9-212/ /13 211/12 21/11 29/1 28/9 2 Apr May Jun Jul Aug Sept Oct Nov Dec Jan Feb Mar

5 Increasing Research Capacity at KGH Research capacity depends on our staff. The research team consists of eight research nurses, two research governance staff, a part time admin post and two clinical research assistants. The support services from Pharmacy, Pathology, Radiology and Medical Records contribute enormously to the delivery of studies. Training In order to undertake research, staff must be trained in Good Clinical Practice. Good Clinical Practice (GCP) is an international quality standard that is provided by International Conference on Harmonisation (ICH), an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. ICH GCP training sessions were set up at KGH in 212/13 in order to train staff. To date there are 11 KGH staff members trained to ICH GCP standard, who hold a certificate of completion. Publications In the last year, 13 publications, 13 posters/presentations and three MSc/dissertations have resulted from our involvement in research, which shows our commitment to improving patient outcomes and experience in Kettering General Hospital NHS Foundation Trust. Where Research Makes a Difference The outcomes from research trials are published and the challenge is then to translate the research evidence into patient care. KGH takes part is a range of studies, as detailed earlier in this report, the following trials show how research can have a positive impact on clinical practice and produce significant cost savings for the NHS. ICU and A&E: Calories & Promise One of the crucial issues of the impact of research in clinical practice has been to raise awareness among the clinical team about the importance of the quality of the data. A thorough understanding of the importance of recording data clearly in the source document has been reiterated among the nursing and medical staff. To improve quality of data, a new drug chart has been devised to include data which will be useful for the Calories trial, and also to improve the quality of care and safety provided to patients. In addition, Calories and Promise trials have emphasised the role of staff learning, development and empowerment as aspects of developing quality services. The junior doctors have been encouraged to undertake research activities under direct and indirect supervision as part of implementing evidence- based practice. The recruitment of patients is used as evidence of participation in research activities, and this is used as part of their Continuous Professional Development.

6 The fundamental aim of evidence-basepromoting the delivery of safe and effective care. The A&E team have been proactive in practice is to support practitioners in making decisions, and implementing a new Sepsis Pathway which will include the guidelines of the Promise trial. This will help to improve the early recognition and treatment of patients showing early signs of sepsis. The introduction of an Intensive Care Unit log book had been implemented as a result of the Spotlight study, whereby patients who were seen by the team would be recruited onto the study. The book is now used for audit purposes, and for recording the number of patients seen by the clinical team within the Trust. The book is also used to handover acutely ill patients who are seen daily on the wards, which enables the team to be proactive about potential admission. Research activities are deeply embedded in the daily routine and there is a positive attitude towards improving research activities in the new Intensive Care Unit. Cost savings on cancer trials: AML 17 Many research studies are fully funded and in this study Clofarabine is provided free. Patients also get access to Mylotarg which costss 1,3 per dose, and results seem to suggest that this drug may result in increased survival rates. There are also potential savings when some patients are randomised into receiving 3 treatments rather than 4. When each treatment can result in a one month inpatient stay, this amounts to substantial savings. Spirit There are no drug savings in this trial, however, twice a year patients receive a pathology test (BCR- ABL) which is carried out at Hammersmith Hospital instead of at KGH, saving 27 per year. Spirit 2 In addition to the above saving on pathology testing, patients on the trial arm receive Distimab free of charge. This replaces the standard drug Imatinib, generating a per patient saving of 41,968 (this saving is passed through to the commissioners, and does not remain at KGH). Pacifico Rituximab is provided free of charge on the trial, saving 8,318. Myloma XI Patients are normally prescribed Thalidomide as a first treatment, and when (not if) they relapse, they are given Lenidomide. For this trial, the Lenidomide is being given as the first drug, and is being supplied at the cost of Thalidomide. For each patient who is on the trial the saving is that there is a cost reduction from the point they would normally be put onto Lenidomide. Given the price difference between the two drugs, this can be quite substantial. We have estimated this at 43, per year to date for the 14 patients on the trial, although again, this will be passed to the commissioners. There is also a saving in blood tests.

7 SCOT On this trial half the patients get routine treatment, the other half get a reduced number of cycles. Therefore the saving is half the drug cost. This has been calculated at 16, year to date. Finally, we acknowledge there are further savings relating to the fact that the trial nurse team treat the patients, this means they do not need to be seen by KGH funded nurses. Future Strategy Research at KGH is almost completely funded by Leicester Northants and Rutland Comprehensive Local Research Network (LNR CLRN). In April 214 CLRN will merge with Trent CLRN to form a Local Comprehensive Research Network (LCRN). There is some uncertainty around the future funding model. For the financial year 213/14 CLRN funding has been cut by 1% resulting in funding to KGH and all other trusts in LNR receiving a reduction in funding. This reduction means we must review staffing activity based funding and are unable to fill any vacant posts. The plan is to aim for a similar level of recruitment to portfolio studies as achieved this year. The implementation of research evidence is essential for quality improvements and the development of innovation at KGH and this will be incorporated into the future strategy. The Trust is keen to adopt Innovation and is planning to work in partnership with Health Enterprisee East (HEE). The plans are to raise awareness amongst our staff of innovations, evaluation of unique ideas and ensure that we protect intellectual property. Dr Gwyn McCreanor Associate Medical Director Clinical Lead for Research