NEWS FROM THE WEST MIDLANDS MEDICINES FOR CHILDREN RESEARCH

NETWORK SPRING 2011

West Midlands Medicines for Children Research Netwo rk 5th Annual Meeting

Thursday 30th June 2011— 9.30 am til 4.30 pm The Hilton Metropole Hotel, Birmingham

See Page 10 for more details

Summer will soon be here and with it our 5th Annual General Meeting which will take place once more at the Hilt on Metropole Hotel in Birmingham. The programme is varied, of h igh quality and I hope will appeal to many. I look forward to seeing you all there. We continue to increase our recruitment int o children’s medicines studies and the last 12 months has been b est so far. One of the challenges we have is that there are onl y a small number of studies suitable for general paediatrics. Many of the ones available at present are those requiring terti ary care expertise. There are however a number of studies o n the horizon which are of a non-medicines nature and we hope tha t these will be usefully taken up by many of you in the District General Hospitals. From the financial point of view resear ch has been relatively spared compared to clinical funding and so for the next

two years we don’t see much change taking place. O ur Research Champions will have funding until 2012. We will need to look at innova tive ways of maintaining Research Champion support after that. There are a number of GCP courses running across the region and a list of those dates can be found later in the newsletter. I look forward to seeing you all at the Metropole.

♦ Read about one of our Young Persons Group’s experie nce as a member of the WM-MCRN Advisory Board P3

♦ WM-MCRN supporting research projects within Queen’s Hospital, Burton P4

♦ An MCRN and PCRN Collaboration P5

♦ Staff Update P5

♦ GCP Training Dates in the region P6

♦ Trial News—activity in North, Central and South of the region P7

♦ Trial Activity—a list of studies open and in setup P8/9

♦ Information about our Annual General Meeting 30th J une 2011 P10

♦ The Team—who’s who and where they are based P11

THE INSIDE STORY

A NOTE FROM THE WEST MIDLANDS MCRN DIRECTOR — PROF WARREN LENNEY

EXPERIENCES OF THE WEST MIDLANDS MCRN ADVISORY BOAR D BY SOPHIE ROBINSON PATIENT REPRESENTATIVE

Sophie Robinson, a member of the West Midlands Advi sory Board, talks about her experience of the meetings she has attend ed. The group’s objective is to advise on the activities of the Wes t Midlands Local Research Network and Sophie’s role is as a young pe rson with a patient perspective.

Why I decided to take part

I was first approached to become a part of the West Midlands MCRN Advisory Board through the Young Persons Group , for the MCRN, based in Birmingham Children’s Hospital of wh ich I am also a part. I was more than happy to get involved for a number of reasons. Already having some experience within t he Young Person’s Group I understood the importance of improving children’s r esearch and the Advisory Board was another way of getting involved. Also, I liked the idea of being able to discuss with doctors and researchers, face to face, any ideas/issues/vie ws from a young person’s perspective.

Pre - first meeting

Before my first meeting on the Advisory Board I was sent minutes from the previous meeting and was also able to discuss what the aim o f the Advisory Board is about, particularly my own role and what to expect . I fe lt prepared for the meeting after a short discussion about what would be discussed that day s o I was able to think about the issues before hand as well and I was also introduced to Pr ofessor Lenney before the meeting.

Thoughts on my first involvement with the board

Immediately, I was introduced and welcomed into the meeting. I was also given time to have my input on discussions. Questions were, when appropriate, handed to me, in terms of my thoughts and ideas on the topic. This made me feel very valued within the board, as my ideas and questions were bought into following q uestions and board members answered them clearly. I felt my perspective, from a young person’s point of view was of great value and helped raise issues that would be d iscussed in further detail at following meetings.

The only difficulties I found were being able to un derstand the jargon used and any medical terms or abbreviations that were mentioned. However, this was kept to a minimum and did not affect my involvement.

The WM-MCRN would like to thank Sophie for her cont inued and dedicated support within the MCRN Young Person’s Group and WM-MCRN Advisory Board.

Photo from visit to Imperial college London to do some experiments looking at Stem cell research

Since commencing paediatric research projects at Bu rton, we have discovered and benefited from the varied range of support that the Medicines for Children Research Network is able to offer. Utilising this support w e have worked closely with the WM North team based at UHNS, enabling us to facilitate resea rch in the paediatric department.

Our first experience was with the launch of ‘MAGNET IC’. Initial practical assistance was provided by Marie Phipps who was instrumental in a rapid gathering of all the CVs and GCP certificates required to enable as many staff as po ssible to participate in the study, thus helping us surpass our target recruitment level. L iaison with the WM- North team has allowed us to share ideas and experiences of runnin g various trials and develop solutions to resolve problems encountered. Frequent contact with the WM-North team ensures we are aware of new studies that we may be able to partici pate in. Another team member, Katharine Beamond has provided education sessions a nd guides that she has developed for new studies.

Acting as a ‘follow on’ site for the I2S2 trial was a new experience for us, but Rachel Jackson, Neo- Natal CRF Central / South has been extremely helpfu l, returning twice to deliver an introduction to the trial for the NNU st aff and medical teams as they changed, and providing and advising on the documentation and st udy requirements.

Other aspects of support have been the willingness of Dr. Sam Hayton to provide GCP sessions for the department, and the provision of h elp and advice given by Gemma Slinn with regard to the set-up process of new studies. T he assistance of all WM-MCRN staff that have helped us in different ways is very much appre ciated.

The continuing support of the WM-MCRN combined with the enthusiasm and commitment of Dr Ahmed, Burton’s Paediatric Consultant and Research Champion, have been crucial elements of developing research within the paediatr ic department at Burton. A full-time paediatric research nurse, Stephanie Boswell, has b een appointed and we look forward to continuing to work with the MCRN.

By Jane Maiden, Research Nurse

(Featured in the photo are Dr M Ahmed, Consultant Paediatrician and Research Champion (on the right. ) and some of the Paediatric Team that have contributed to the success in Paediatric Trials at QHB)

WM-MCRN – SUPPORTING RESEARCH PROJECTS WITHIN QUEEN’S HOSPITAL, BURTON

Atherstone Medical Centre are involved in an indust ry funded study comparing two vaccines, when co-administered with the MMR. This study is co-adopted by PCRN.

The practice is to recruit 10 patients, aged 3-4 ye ars.

The research team consists of 2 GP’s, Dr Trevor Goo ding and Dr Samir Purnell-Mullick and 3 research nurses. De borah Weston, Fiona Gooding and Elizabeth Thomson. My role has be en to undertake blood sampling pre-immunisation and a sec ond blood sample 28 days post vaccination.

To date we have seen six patients for their first v isit, and two patient for their 28 day post immunisation blood te st.

Atherstone Medical Centre has taken part in many re search studies and has a very experienced team. I have really enjoyed working on this study and experiencing research in a Primary Care setting.

I would like to thank the whole research team at Atherstone for the support I have had at each study visit to date.

By Rachel Jackson, CRF

AN MCRN AND PCRN COLLABORATION

Deborah Weston, Rachel Jackson and Elizabeth Thomson

STAFF UPDATE

New Starters Sugrah Sultan is due to start in Birmingham Children ’s as a Clinical Research Facilitator. Sugrah isn’t a stranger to BCH as she has been work ing there as a nurse in general paediatrics. We look forward to welcoming her to t he team. We are also looking forward to welcoming Jane Lovatt who is coming as a CRF fro m Heartlands where she is currently working as a nurse supporting the I2S2 trial

Welcome to Lorna De Bourg and Ruth Jones who have s tarted working for University of North Staffordshire as Paediatric Clinical Research Facilitators. They will be working on MCRN and Non-Medicines studies. We look forward to working closely with them.

Stephanie Boswell was the successful candidate for the Paediatric Research Nurse post working for the Trust at Burton. She was instrument al in the set up of MAGNETIC in the department and assisted throughout the course of th e study. Stephanie is due to start her new role on 27/06/11.

NORTH GCP Dates

CENTRAL GCP Dates

SOUTH GCP Dates

GCP TRAINING DATES

Details of all local courses can be found on www.cr ncc.nihr.ac.uk/training/courses

Course Title Date Venue Introduction to GCP 14th June 2011 Medical Institute, New Cross Hospital, Wol-

verhampton Introduction to GCP 12th July 2011 Post Graduate Centre, Stafford Hospital

Introduction to GCP 23rd September 2011 Medical Education Centre, Queens Hospital, Burton

Introduction to GCP 29th November 2011 Robert Jones Agnes Hunt District and Or-thopaedic Hospital

Introduction to GCP 24th January 2012 North Staffordshire Conference Centre, Stoke-on-Trent

Introduction to GCP 20th March 2012 Shropshire Conference Centre, Royal Shrewsbury Hospital

Course Title Date Venue

Introduction to the Process of Informed Consent in a Paediatric Setting

3rd June 2011 Birmingham Children’s Hospital

Introduction to GCP 8th June 2011 Delta House, Delta Point, West Bromwich Introduction to GCP 23rd June 2011 Barberry Centre, Vincent Drive, Birming-

ham Introduction to GCP 8th July 2011 Queen Elizabeth Hospital, Birmingham Introduction to GCP 20th July 2011 School for Cancer Studies, Birmingham

University Introduction to GCP in a Paediatric Setting

20th September 2011 Birmingham Children’s Hospital

Introduction to GCP in Primary Care

20th September 2011 The Moat House, Acton Trussell, Stafford

Course Title Date Venue

GCP Refresher 6th June 2011 Worcester Royal Hospital

Informed Consent in a Paediatric Setting

14th June 2011 University Hospital of Coventry

Introduction to Research Manage-ment & Governance

27th June 2011 University Hospital of Coventry

Introduction to GCP 4th July 2011 University Hospital of Coventry

Introduction to GCP 8th September 2011 University Hospital of Coventry

Introduction to Research Manage-ment & Governance

TBC Hereford County Hospital

Introduction to GCP 11th October 2011 Warwick Hospital

GCP in a Paediatric Setting 3rd November 2011 University Hospital of Coventry

GCP Refresher November 2011 George Elliott

GCP Awareness (Site File Audit) 12th December 2011 University Hospital of Coventry

TRIAL NEWS West Midlands North

MAGNETIC was closed early to recruitment on 21st Ma rch 2011 because the national target had been achieved. UHNS and Burton both achieved a nd exceeded their targets by one patient each.

SLEEPS opened at UHNS on the 16th March and two pat ients have been recruited. The 1st was within the 4 weeks recruitment target.

Infant Influenza Study has now closed at all centre s (UHNS, Shrewsbury and Telford and Burton in the North). Burton over exceeded their t arget of 10 by recruiting 13 patients. 4 recruited at Telford, 2 recruited at UHNS and 2 a t Shrewsbury.

JUMP—1st Phase 2 patient is being seen in June at UHNS. Burton have seen two Phase 1 patients in May.

TORPEDO- 1st patient was recruited at Wolverhampton on 24th May.

Thanks to all of you who have assisted with these t rials.

West Midlands Central

JUMP has hit its target of 16 patients recruited to phase 1 in the central MCRN area. The hospitals where the patients were recruited were:- Birmingham Children’s Hospital (10)Heartlands Hospital (3), Walsall Manor Hospital (2) and Russells Hall Hospital (1). Facilitating the study at three different sites was sometimes co mplex, as this meant communicating with several teams, each with individual ways of working . Thanks go to all the outpatient teams at each hospital for their continued help and support.

CHiP (PICU) - 10 patients were recruited in March a t BCH which is the highest monthly figure since the study opening in April 2008.

POP—1st patient since July of last year was recruit ed during March at BCH.

West Midlands South

ADDRESS (After Diagnosis Diabetes Research support System) trial — CRF’s Karen Miles and Fiona Thompson have began to approach eligible patients at Coventry. The aim of the study is to facilitate future research in type 1 diabetes by establishing a support system to facilitate future research in type 1 diabetes. This system will consist of a database of individuals with new –onset type 1 diabetes who hav e consented to be contacted by the study team about future type 1 diabetes research. F eedback from potential recruits has been very positive with those approached agreeing to con sent.

We do have 5 recruits for Phase 1 of JUMP, 2 of whi ch are eligible and have agreed to take part in Phase 2 and are both are booked to come in the next couple of weeks to Coventry.

WEST MIDLANDS MCRN TRIAL ACTIVITY Acronym Area of Interest Status LRN site

AdDit (DRN068) Diabetes Open BCH

ADDRESS (DRN094) Diabetes Open UHCW

CHARMS 2 Rheumatology Open BCH

CACE Methodology Open UHNS

CATCH Anaesthesia, Pain and PICU

In Setup BCH

CHiP (PICU) Anaesthesia, Pain and PICU

Open BCH, UHNS

CHIPS HIV Allergy, Infection and Immunity

Open HEFT, UHNS

Detemir-Glargine Endocrinology Open BCH, UHNS

DUCHENNE (Heart Pro-tection)

Neurosciences In Setup HEFT, RJAH

Extended Biologics Rheumatology In Setup BCH, GEH, UHCW, UHNS

GAS Anaesthesia, Pain and PICU

Open BCH

ICISS Neurosciences Open BCH, Burton Hospitals, DGoH, HEFT, Mid Staffs, RWH, SWBH, SaTH, South Warwickshire Hospitals, UHNS, Walsall Hospitals, Worcs Acute, Wye Valley Hospitals

I2S2 Neonatal Open BWH, HEFT, SWBH (In Setup at UHCW)

JDCBS Rheumatology Open BCH

JUMP Endocrinology Open BCH, Burton, DGoH, GEH, HEFT, SWBH, SaTH, UHCW, UHNS, Walsall Hospitals, Wye Valley Hospitals

Kidney Kids Research Renal Open BCH

MCRN042 (SCO-BIA) Neurosciences Open BCH

MCRN044 (Betapedic) Neurology In Setup BCH

MCRN046 (MPS VI CSP) Metabolic Disorders Open BCH

MCRN047 (Aranesp) Renal In Setup BCH MCRN058 (Hunter-Elaprase)

Metabolic Disorders Open BCH

MCRN065 (Infant Influen-za Safety Study)

Allergy, Infection and Immunity

Open BCH, Burton Hospitals, HEFT, SWBH, SaTH, UHNS, Worcs Acute

MCRN080 (Remicade) Gastrointestinal Open BCH

WEST MIDLANDS MCRN TRIAL ACTIVITY

MCRN088 (Paracalcitol)

Renal Open BCH

MCRN092 (HGT-HT-50) Metabolic Disorders Open BCH

MCRN094 (Liraglutide) Endocrinology Open BCH

MCRN099 (Factor XIII PK)

Haematology In Setup BCH

MCRN100 (Factor XIII Ext.)

Haematology In Setup BCH

MCRN105 (Entecavir) Hepatology In Setup BCH

MCRN106 (MOR–004) Metabolic Disorders Open BCH

MCRN115 (PMREC1206)

Hepatology In Setup BCH

MCRN119 (HGT-HT-45) Metabolic Disorders In Setup BCH

MYCYC Renal Open BCH

NFS (DRN085) Diabetes Open BCH, HEFT

PENTA 16 (Breather) Allergy, Infection and Immunity

In Setup HEFT, UHCW, UHNS

PENTA 18 (KONCERT) Allergy, Infection and Immunity

Open HEFT, UHCW, UHNS

POP Rheumatology Open BCH

PREDNOS Renal In Setup BCH, Burton Hospitals, SaTH, UHCW, Worcs Acute, Wye Valley Hospitals

PUDDLS Neurosciences Open BCH

RaDaR Renal Open BCH

SCIPI Diabetes In Setup BCH

SLEEPS Anaesthesia, Pain and PICU

Open BCH, UHNS

Torpedo-CF Respiratory In Setup BCH, RWH, UHCW, UHNS

TrialNet (DRN100) Diabetes In Setup BCH

TROPHOS19622 Neurosciences Open HEFT

UK JSLE Cohort Study Rheumatology Open BCH, GEH, UHCW

Acronym Area of Interest Status LRN site

West Midlands Medicines for Children Research Network (WM-MCRN) and our

Young Person’s Group invite you to their

5th Annual Meeting

Thursday 30Thursday 30 thth June 2011 9.30am June 2011 9.30am -- 4.30pm4.30pm The Hilton Metropole Hotel, BirminghamThe Hilton Metropole Hotel, Birmingham

A meeting including lunch, where you will be able t o A meeting including lunch, where you will be able t o

meet the members of the team and to meet the members of the team and to network with colleagues.network with colleagues.

Who is our meeting aimed at?

If you are working on any paediatric research study in the West Midlands MCRN area, that is on the Nationa l Institute for Health Research (NIHR) portfolio, or if you

are interested in starting up a project.

Our aim for the day The aim of the meeting is to give you a better

understanding of what the WM-MCRN do, how to access the support that can be provided by us, and give yo u an update on developments that have taken place. Also to

share our success of the past year……..

Registration is free. CPD points will be available for attending the event.

For further information please contact: Cathy Fore man on cathy.foreman@uhcw.nhs.uk

THE TEAM

Professor Warren Lenney Dr Kevin Morris Dr Heather Stirling

Network Director/Clinical Lead Clinical Lead Central Clinical Lead South

North

Dr Sam Hayton Krys Castro Louise Bradbury

Network Manager Senior CRF North Senior CRF Central

Claire Callens Carly Tibbins Gemma Slinn

User Involvement Co-ordinator User Involvement Research Portfolio Manager

Co-ordinator

Katharine Beamond Marie Phipps Hilary Shepley

CRF North CRF North CRF North

Emily Benson Indy Birak Jenna Shaw

CRF Central (on Maternity) CRF Central Non-Meds CRF Central

Bethany Hanson Rachel Jackson Tracey Kirkwood

CRF Central Neo-Natal CRF Central/South Joint Wellcome/MCRN

CRF Central

Fiona Thompson Karen Miles Sarah Reynolds

CRF South CRF South CRF South

Cathy Foreman Surjit Minhas Gerri Mulcahy

Network Support Officer PA/Network Administrator PA/Network Administrator

South Central North

Claire Norton Professor John Marriott Rebecca Venables

MCRN Pharmacist MCRN Formulations MCRN Research Fellow

Website You can view this at www.meds4kids.nhs.uk.

North —01782 662579 Central—0121 333 8739 South—024 7696 7003

If you have any queries regarding this newsletter or have a contribution for future

editions please contact gerri.mulcahy@uhns.nhs.uk.