All new projects created in IRAS version 3.3 will be submitted via the new electronic interface (with both forms and documents) into the CSP Module.

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1 It s ABF Time again! by Richard Hart (Information Manager, Trent CLRN) Recruitment data reported for NIHR portfolio adopted studies will once again be used to inform Activity Based Funding (ABF) allocations to the Comprehensive Local Research Networks for the next financial year. The CLRN funding for 2012/13 will be used to provide service support (including clinical research infrastructure) and research management and governance for our 15 member NHS Trusts. As last year, the funding model will draw on a full year s activity data, and will use reported recruitment information for studies on the NIHR portfolio database. The ABF period in which recruitment will be counted is from 1 st October th September 2011, and the absolute deadline for the reporting of recruitment is Friday 14 October Therefore your help is requested to ensure that all of your recruitment is uploaded to the NIHR Portfolio database. We don t have long before the end of September! If you are working on an NIHR adopted study please ensure that your recruitment figures are reported regularly (at least once a month) to the Chief Investigator or their trial co-ordinator. If you are the CI and need assistance with uploading recruitment, please let me know. With best wishes Richard Hart, Trent CLRN Information Manager RDMIS CSP Module launched The first stage of a new system to support the NIHR Coordinated System for Gaining NHS Permission (CSP) was introduced on 18 July for new studies created in IRAS version 3.3. All new projects created in IRAS version 3.3 will be submitted via the new electronic interface (with both forms and documents) into the CSP Module. All projects already created in IRAS prior to IRAS version 3.3 will continue to be submitted through the existing interface into CSP ReDA for an interim period. A timetable will be set for the full migration of the data from CSP ReDA into the CSP Module, which is likely to be in August/September. After this, any studies that were being processed through CSP ReDA (or with new sites or amendments) will be managed in the CSP Module. Great SCOT! 2 The NIHR Clinical Research Network - has it been a success for dermatology trials? 4 GCP Training dates 5 Delivery, delivery, delivery: sharing best practice 6

2 Great SCOT! A major research project into the safety of long term pain relief for sufferers of arthritis has taken a significant step forward with the recruitment of its 4000 th patient. The SCOT study (UKCRN ID 7681) is designed to examine the effectiveness and safety of drugs commonly used to treat the pain of arthritis. Patients in the East Midlands are being invited to join the study, which could benefit millions of patients with arthritis around the world. This study is designed to answer an important scientific question, which has the potential to improve the care of the thousands of arthritis sufferers across the UK. It is the first large-scale safety study of its kind, and really will make a difference to future prescribing within primary care. Professor Chris Hawkey, Professor of Gastroenterology, University of Nottingham The group of drugs most commonly prescribed to treat the pain of arthritis, Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) includes familiar names such as ibuprofen (Brufen ) and diclofenac (Voltarol ) which are commonly used to relieve joint pains. Often they do that job well, which is why they are so popular. Millions of prescriptions are written in the UK every year for NSAIDs, not counting all the ibuprofen sold 'over-the-counter' in pharmacies and shops. Despite this, like all drugs, NSAIDS can have side effects. These include irritation of the digestive system and effects on blood pressure and the heart. In recent years a new group of NSAIDs has been developed called `Cox-2 inhibitors. These Cox- 2 inhibitors have been shown to be less harsh on the digestive system than the most popular existing NSAIDs, leading to fewer stomach ulcers and bleeding. However, early studies on one of these new drugs suggested an increase in the risk of raised blood pressure and heart problems, but the balance between benefits and possible risks is not known. The aim of the SCOT study is to find out if celecoxib - the most widely prescribed of the Cox-2 inhibitors - is better, worse or just the same as the other available NSAIDs in terms of cardiovascular and digestive system safety. The SCOT study, led by Professor Tom MacDonald, of the Medicines Monitoring Unit at The University of Dundee, is supported by seven other Universities and research institutes across Scotland, England, Denmark and the Netherlands, making it one of the biggest ever studies run by a Scottish university. This information will be of great value to everyone who needs to take these drugs on a regular basis, which is millions of people around the world. The findings will allow doctors and people with arthritis to make the best choice, not just for their joint pains but also for their general health, said Professor MacDonald. Professor Chris Hawkey, of the Nottingham Digestive Diseases Centre at Nottingham University Hospital (QMC), is running the SCOT study locally, and has successfully recruited over 200 patients and 25 GP practices around the Trent area. He hopes to recruit 1,000 patients over the Page 2 Great SCOT! (continued on Page 3)

3 Great SCOT! (continued from Page 2) next year. The following are the team based in Nottingham: Principal Investigator: Prof Chris Hawkey, Professor of Gastroenterology, University of Nottingham. Sub-Investigator: Dr Anthony Norman, SpR Gastroenterology, Nottingham University Hospitals NHS Trust Trial Coordinators: Jen Dumbleton and Diane Stevenson, University of Nottingham. Research Nurses: Vic Shepherd, Research Nurse Manager and David Goddard, Senior Research Nurse, Nottingham University Hospitals NHS Trust. Trent CLRN Support: Susan Slininger and Andrew Dainty, Research Nurses, and Sharon Caunt, Trial Coordinator. Recruitment in Nottingham started in September 2010, and we currently have 238 patients (of our 1000 patient target) recruited to the trial, and are recruiting in GP practices across Nottinghamshire, Derbyshire and Lincolnshire. The trial will also soon start recruiting in South Yorkshire, Leicestershire, Northamptonshire and Rutland. Further information can be found at Any GP practices who would like to participate in the trial, please get in touch with Jen Dumbleton, , Editor s notes: Arthritis affects around 10 % of adults at some time in their life. The SCOT Study is currently running in over 470 GP centres across Scotland, the Midlands, Yorkshire, and the Home Counties of England and across Denmark & The Netherlands. The current patent for Celecoxib expires in 2014, allowing the drug to be produced generically and sold at a significantly lower price, slashing the price the NHS has to pay. Page 3

4 The NIHR Clinical Research Network - has it been a success for dermatology clinical trials? by Kim Thomas, Associate Professor, Centre of Evidence Based Dermatology, University of Nottingham Researchers at the University of Nottingham s Centre of Evidence Based Dermatology have recently published an article in the open access journal Trials highlighting the benefits of working with the NIHR s Research Networks to deliver their non-commercial clinical trials 1 content/12/1/153 The article describes some of their early experiences in linking with several of the NIHR CRN networks in order to deliver dermatology trials, and discusses the challenges and lessons that they faced. Using case studies based on two trials: the Softened Water Eczema Trial (SWET) 2 and Prophylactic Antibiotics for the Prevention of Cellulitis Trial (PATCH I) 3, the article highlights the benefits of researchers and network staff working in partnership together in order to achieve the same shared goals. The additional resource allocated to the trials highlighted in this publication meant that both studies recruited to target, and that two important clinical questions have now been addressed. However, the article also highlights the challenges facing the NIHR in that simply increasing resources was not sufficient in isolation. Neither of the trials would have benefited from the increased financial support without the availability of experienced and extremely dedicated research teams, who strove to ensure that the trials were of high quality and delivered to target. Success was driven by a genuine partnership between the research teams and the flexibility of network support. For both trials, raised public awareness was key. Further input into the ways in which research networks can be used to engage with members of the public (particularly in highlighting ongoing trials), as well as initiatives to improve the public s understanding of clinical research, would be beneficial. The next challenge for researchers is to find novel and innovative ways of ensuring that new research is implemented into practice, and to look at ways of building treatment evaluation into normal clinical practice. References: 1. Thomas KS, Koller K, Foster KA, Perdue J, Charlesworth L The UK Clinical Research Network has it been a success for dermatology clinical trials? Trials : Thomas KS, Dean T, O Leary C, Sach TH, Koller K, Frost A, Williams HC and the SWET Trial Page 4 Success for dermatology (continued on Page 5)

5 Success for dermatology (continued from Page 4) Team. A randomised controlled trial of ion-exchange water softeners for the treatment of eczema in children. PLOS Medicine 2011; 8 (2): e UK Dermatology Clinical Trials Network's Patch Study Group. Prophylactic Antibiotics for the Prevention of Cellulitis. Journal of Lymphoedema, 2007; 2(1), Editor s Note: The SWET article won the award for Best Paper at the British Association of Dermatologists Annual Conference July Take heart! Trent CLRN is funding a part time Band 7 echo cardiographer post (0.5WTE) at NUH, who will be able to perform echo s per week. This will improve collaboration between Cardiology and the Mid-Trent Cancer Research Network. A great example of unblocking the blocks! SwiFT update We were very pleased to receive this message from Professor Kathy Rowan, Chief Investigator for the SwiFT Study which recruited 80 participants in the Trent CLRN area. May I take this opportunity to thank you for your significant contribution to the SwiFT Study. Not only was it a very rapid commission for us, but it also required a very rapid, positive response from you and your research/clinical team. I believe that the combination provided a very important piece of research with results which will hopefully inform future research governance, critical care triage and pandemic monitoring. The Swine Flu Triage (SwiFT) study (UKCRN ID: 7396): Development and ongoing refinement of a triage tool to provide regular information to guide immediate policy and practice for the use of critical care services during the H1N1 swine influenza pandemic GCP Courses (Good Clinical Practice): 31 August 2011, QMC Nottingham 11 October 2011, Pilgrim Hospital, Boston 11 November 2011, QMC Nottingham Page 5 NIHR CRN Workforce Development Enabling learning and development in the Clinical Research Network Book your place online at: booking-courses.html If you need further details, please contact the Course Facilitators: Penny Scardifield, Ext: or Jetta Holmes Ext 70670

6 Trent CLRN day to day contacts Professor Oleg Eremin, Clinical Director Janet Boothroyd, Senior Manager Sheila O'Malley, Lead RM&G Manager Jane Flewitt, Administrator Penny Scardifield, Lead Nurse Trent Comprehensive Local Research Network DELIVERY, DELIVERY, DELIVERY: SHARING BEST PRACTICE Thursday 29 th September 2011 East Midlands Conference Centre University Park, Nottingham Richard Hart, Information Manager David Papworth, Information Co-ordinator Lynsey Judd, Industry Manager Nicholas Hamilton, Industry Research Officer Christina Brindley, Lead Network Facilitator Tracy Leavesley, CSP Administrator Hannah Finch, Senior RM&G Manager Daniel Kumar, Senior RM&G Manager Nicola McMaster, Senior RM&G Manager Speakers will include representatives from the Department of Health (DoH), the National Institute of Health Research (NIHR) and constituent NHS Trusts. Afternoon workshops on: Research Management and Governance Industry Studies Training and Support of the Research Nurse For further information please contact: Jane Flewitt Trent CLRN Administrator Tel: ext Please note there is no charge for attendance at this event Shirley Mitchell, Senior RM&G Manager Page 6