The National Institute for Health Research Sheffiel d Clinical Research Facility is a partnership betwe en the Sheffield Teaching Hospitals NHS Foundation Trust and Univers ity of Sheffield.

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WelcomeWelcome

Issue 4, December 2013

Sheffield Clinical Research Facility Sheffield Clinical Research Facility Sheffield Clinical Research Facility NewsletterNewsletterNewsletter

...to the festive edition of the NIHR Sheffield Clinical Research Facility (CRF) newsletter. There is a lot to celebrate this month, including: ♦ STH has been named in the top ten for the number of clinical trials

it is offering to patients and 79% of people think it is important for the NHS to carry out clinical research. Read more on page 4.

♦ Read how patient and public involvement is improving outcomes in research on page 3.

♦ NIHR launches its “Research changed my life” campaign; read how to get involved on page 4.

Professor Chris Newman

Welcome...Welcome...

MHRA Inspection Announced The Trust has received advance notification from the Medicines and Healthcare products Regulatory Agency (MHRA) of a Statutory GCP Inspection of non-commercial drug trials that the Trust sponsors and also those with external academic/NHS sponsors that the Trust hosts. This is a routine risk-based inspection to examine the systems used by STH in the conduct of clinical trial research. The Trust has submitted an Inspection Dossier to the MHRA and further infromation about the inspection is awaited.

First global dosing in dermatology trialFirst global dosing in dermatology trial

A CRF dermatology study has randomised the first patient globally, with the first dose being administered by Professor Michael Cork on 15th November, only 11 days after site activation. Professor Cork, Head of Academic Dermatology Research in the University of Sheffield, is the UK Chief Investigator for the study. Prof Cork is involved with research in many areas of dermatology including atopic eczema, psoriasis, vitiligo and the genetics of skin disease. This new commercially sponsored, portfolio trial (UKCRN ID 15249) is an early phase 2 study looking at a new oral medication for the treatment of atopic dermatitis, to determine whether patients benefit from this therapy and whether there is a genetic variation in efficacy. There is a marked clinical need for oral non-immunosuppressive therapeutics that may be effective for atopic dermatitis and accordingly this study has received funding from the UK Technology Strategy Board Biomedical Catalyst Fund. If results are positive this could offer a safe and effective therapy for dermatitis sufferers, which can be delivered conveniently by the oral route.

Researchers from STH’s respiratory medicine department are currently leading a number of studies looking at new drugs and treatments which could benefit people with lung diseases such as bronchiectasis. One patient participating in a CRF respiratory study is Julia Anne Finney, 69, of Wath-Upon-Dearne who suffers from bronchiectasis, which is a little understood illness causing severe tightening in the chest. Around 1 in every 1,000 adults in England suffer from the condition. Unlike other lung diseases bronchiectasis occurs as a result of damage to lungs when patients were younger. Julia, a former midwife, who suffers from this rare lung illness is urging others to find out more about the benefits of clinical research. Julia said: “Since my illness got worse I’ve had to really slow down – even taking my daughter out shopping can be difficult. I used to really enjoy gardening, too, but I can only manage half an hour before I have to stop. When I was a midwife I used to work round the clock, working on-call and doing night shifts, so I just want to give hope to other patients.” Julie Sorrell, CRF Research Sister said: “Imagine your worst chest infection and then times this by 20 – this is what life is like for bronchiectasis sufferers. It’s a little talked about disease, and as well as supporting patients to manage an illness which can make them really poorly, our research gives realistic hope for the future.” Read the full article online here: http://www.thestar.co.uk/news/healthy-living-trials-inspire-julia-to-make-most-of-life-1-6052994

CRF respiratory study featured in The StarCRF respiratory study featured in The StarCRF respiratory study featured in The Star

Improving healthcare for the benefit of patients Page 2

Sister Pauline Bayliss is the lead CRF nurse on the

GOSH study, which is looking at a possible genetic

component to bleeding around the brain. The

recruitment target has been surpassed by 100%: at

present there are 108 recruits.

STH has completed recruitment to an NIHR

HTA trial, 2 months ahead of schedule! The trial, led

by Steven Brown, Consultant Surgeon at

NGH, is looking at surgical treatment of

Haemorrhoids.

CRF investigator publication CRF investigator publication CRF investigator publication highlighthighlighthighlight The following publication arose from a study led locally by Dr Martin Wilkie, Research Lead in Renal Services: Chertow G, Block G, Correa-Rotter R, Drüeke T, Floege J, Goodman W, Herzog C, Kubo Y, London G, Mahaffey K, Mix T, Moe S, Trotman M, Wheeler D, Parfrey P. Effect of cinacalcet on cardiovascular disease in patients undergoing dialysis. New England Journal of Medicine 2012;27(26): 2482-94. The study evaluated the long-term safety and efficacy of tolvaptan in patients with Autosomal Dominant Polycystic Kidney Disease.

The CRF has a volunteer database that can be accessed by researchers. The database holds information of potential volunteers who are interested in participating in clinical research, allowing researchers to identify and contact potential participant cohorts. For further information or to have your details added to the database, please contact Gail Mills, Experimental Medicine Project Manager: Email: gail.mills@sth.nhs.uk or Tel: 0114 2715779.

CRF volunteer databaseCRF volunteer database

Increasing engagement in rheumatology studiesIncreasing engagement in rheumatology studiesIncreasing engagement in rheumatology studies

The STH Research and Innovation featured the CRF’s very own Research Sister Olivia Godia. Olivia has worked closely with the rheumatology outpatients department to encourage rheumatology patients to get involved in clinical research.

As part of the initiative, Olivia has been based in the rheumatology outpatient clinic, improving awareness of research for both patients and staff – with 96 patients recruited to rheumatology studies as a direct result.

Take a look by clicking on the link below: http://www.sth.nhs.uk/research-innovation/news/latest-news?action=view&newsID=7

Patient and Public Involvement improving researchPatient and Public Involvement improving research

The NIHR encourages the involvement of the patient and public in all its research, to set research priorities and ensure research undertaken is relevant to the people it will affect. Recent research by King’s College London also found that involving patients in the design process can

improve study success. The study, published in the British Journal of Psychiatry, analysed the largest database of UK mental health studies and found that studies that had service users as part of the study team were 4 times more likely to recruit to target. Problems with recruitment can be costly, causing studies to overrun or sometimes even stop early. A case study published by Boote et al (2012), a Research Fellow in ScHARR, describes how public involvement in the development of a research bid discovered that the idea was not supported by stroke survivors and carers. Patient involvement at this early stage in the research process ensured that public money was not wasted on research not considered useful to the patient community involved.

The CRF supports over 100 early-phase “proof of con cept” studies

Visit our website: www.sheffield.crf.nihr.ac.uk Page 3

Team working enables successful recruitment to a global haemophilia surgery

study, Pathfinder 2. STH was the 2nd UK site to recruit, as

a result of collaborative working between the CRF,

haemophilia nurses, surgery & coagulation teams and

anaesthetists.

Sheffield is the highest recruiting site in the UK

for an NIHR portfolio obstetric study, having

recruited 24 patients. The study is looking at women

at risk of haemorrhage during caesarean

section.

Research Sister Yvonne Jackson joined the CRF in June 2013, coming from the renal directorate within STH. Yvonne told us about her experiences: “I was working as a clinical nurse specialist in peritoneal dialysis. Part of the specialist nurses role should be to integrate research into clinical practice, but this requires education and training. Following a discussion between matrons and consideration of the service needs, it was agreed that I would spend 12 months in the CRF, with the goal of improving the quality of peritoneal dialysis services through active involvement in research, which underpins the Trust’s five year strategy.” When Yvonne began, she had limited knowledge of clinical research and additional core skills and development needs were identified at the outset, in order that the role was successful. In order to facilitate this transition, Yvonne undertook the UKCRF induction framework and had a

nominated contact point in the CRF nursing team for any queries and day-to-day support. These core skills were consolidated through the Clinical Research Training Programme (www.sheffieldclinicalresearch.org/education-and-training) and with support from the CRF’s Training & Education Lead, Senior Sister Bev Kilner. After 6 months there are now 3 research projects ongoing in the field of peritoneal dialysis and Yvonne is leading on projects both within her specific specialty area and in other renal studies. Yvonne said “This secondment has provided me with the opportunity to experience the true benefit of clinical research; working with patients to improve care and quality of treatment for the future.”.

Embedding research into clinical care through resea rch nurse Embedding research into clinical care through resea rch nurse Embedding research into clinical care through resea rch nurse training in the CRFtraining in the CRFtraining in the CRF

The total number of patient study visits since the CRF opened is just over 35,000 – 5000 of which have occurred since Ap ril 2013

Sheffield named in top 10 for clinical researchSheffield named in top 10 for clinical researchSheffield named in top 10 for clinical research

Sheffield Teaching Hospitals (STH) NHS Foundation Trust has been named in the top ten for the number of clinical trials it is offering to patients in a national league table. New figures published by the National Institute for Health Research (NIHR) rank the Trust 9th out of 390 NHS Trusts for supporting patients to take part in clinical research which could one day revolutionise NHS care. They also show that there was a 12 per cent increase in the number of studies run from the previous year, from 259 to 290, with nearly 7,000 patients taking part. STH is one of the largest teaching hospitals in the UK, and is recognised internationally for its work in neurosciences, spinal injuries, cancer, transplantation and orthopaedics. Dr Jonathan Sheffield, chief executive of the NIHR Clinical Research Network, said: “Patients always tell us how important it is for the NHS to take part in clinical research. In fact, according to our latest consumer poll, 79 per cent of people think it is important for the NHS to carry out clinical research – whilst less than three per cent think it is unimportant. I would like to congratulate the Sheffield Teaching Hospitals NHS Foundation Trust for increasing the number of studies it does locally, and helping to bring research opportunities to patients.” The NIHR Clinical Research Network recruited more than 630,000 patients to clinical studies in 2012/13, a 7% increase on the previous year. This means the Network has tripled patient recruitment in just six years. The percentage of studies recruiting to time and target is improving year on year. Full details of the clinical research league table can be viewed at www.crncc.nihr.ac.uk/nhs-performance.

Positive feedback continuesPositive feedback continuesPositive feedback continues Participant feedback continues to be extremely positive: “Best customer service I have ever seen.” (July 2013)

A commercial portfolio haemophilia study set-up by the CRF co-ordinator team was the 1st site to be authorised & initiated in the UK, ahead of the

lead site in London.

Improving healthcare for the benefit of patients Page 4

On 28th November the NIHR Clinical Research Network launched a national “Research changed my life” campaign to help patients understand the range of positive effects clinical research can have on their lives. The campaign centres on the inspirational stories of people who have taken part in clinical studies.

The website has stories from people all across England, covering all sorts of conditions, containing short-films and video-diaries, alongside audio and written accounts.

Visit http://researchchangedmylife.com/ to get involved

and share your experiences!

“Research changed my life” “Research changed my life” “Research changed my life” --- new NIHR campaignnew NIHR campaignnew NIHR campaign

“Very good and supportive service. Excellent to hav e everything in one place. I felt very well looked after.” (August 2013) “I'll miss it [the CRF] when the study is over!” (July 2013)

New additions to the CRF teamNew additions to the CRF team The CRF Co-ordinator Team recently welcomed two new additions: Lema Vernon and Liz Ralph. Lema previously worked for the South Yorkshire Comprehensive Local Research Network and Liz has a background in the pharmaceutical industry. Both Co-ordinators will support CRF investigators to ensure timely set-up and initiation of research projects.

Visit our website: www.sheffield.crf.nihr.ac.uk Page 5

CRF 2014 Education and Development CRF 2014 Education and Development CRF 2014 Education and Development ProgrammeProgrammeProgramme The CRF Education and Development sessions are available to all researchers within STH. Sessions scheduled for next year include: ♦ Engaging minority groups in research, 14th

February at 2.00pm (CRF meeting room, NGH)

♦ Embedding research in the clinical areas, 14th March at 2.00pm (CRF meeting room, NGH)

♦ Quality assurance & site file maintenance, 11th April at 2.00pm (CRF meeting room, O Floor, RHH)

♦ Late effects in cancer research, 9th May at 2.00pm (CRF meeting room, O floor, RHH)

For more details about these and other training sessions please contact Philippa Ledger � : 0114 271 5779 �:: Philippa.Ledger@sth.nhs.uk

POISE 2, a portfolio grant trial, has successfully

recruited to time and target. The study is looking at

patients undergoing noncardiac surgery who are

at risk of a perioperative cardiovascular event.

Prof Basil Sharrack is the highest recruiter for global Multiple Sclerosis

ASCEND study supported by the CRF. The current number of patients randomised

is 16.

The Jessop Wing have recruited the first patient in the UK for the TERRA trial, - a multi centre commercial

clinical trial looking at treatment for endometriosis. The portfolio-adopted study

also met the 70 day target.

If you have any feedback on the newsletter or would like to contribute to the next issue, we’d be delighted to

hear from you.

Please contact CRF Manager, Karen French: � : 0114 2713339

� : karen.french@sth.nhs.uk

Have a very Merry Christmas!

CRF Staff PublishedCRF Staff PublishedCRF Staff Published CRF Senior Research Sister Abida Nazir is co-author on an abstract submitted to the Meningitis Research Foundation Congress 2013, held in London on 5-6 November. The abstract outlined the findings from the CARRIAGE trial, a phase 3 study evaluating the effect of vaccination in Neisseria meningitidi in young adults. Sister Nicola Bennett (Research Sister in the CRF) is named as a co-author on an executive summary of the WRVS on-ward volunteer initiative. The purpose of this project was to improve the inpatient experience of patients with dementia by using on-ward volunteers recruited and trained by WRVS, supported by a Dementia Nurse Specialist employed by STH. The report can be accessed online here: http://clahrc-sy.nihr.ac.uk/images/TK2A/TK2A%20projects/1.%20WRVS%20Exec%20summary%2029082013.pdf.