NEWS FROM THE WEST MIDLANDS

MEDICINES FOR CHILDREN RESEARCH NETWORK

WINTER 2010

A Note From the West Midlands MCRN Director

“I trust that everyone has enjoyed the cold spell of

weather. As I write this brief introduction it is now

raining hard and its grey and damp. I prefer the cold,

crisp, icy weather but unfortunately we have no say in

this. Similarly, we have no say in future government de-

cisions about funding within the NHS. Lets hope how-

ever, that research programmes are indeed ring fenced

and we can go from strength to strength. We have had

some changes in personnel and in the near future we

hope to be interviewing for Band 7 Research Nurses

within the West Midlands. Sam and I had our bi-annual meeting with Ros and Vanessa in November at the Na-

tional Exhibition Centre in Birmingham. I don’t know if any of you have been

there when there is nothing happening but it is very eerie, cold and reminiscent

of a film set which has been abandoned. The outcome of the meeting was very

successful and in general, Liverpool is pleased with the way we are progressing.

I think we now all recognise the obstacles to paediatric research and I am ab-

solutely certain that without the network, research in children in the UK would

have virtually stopped. I think all of you should have a pat on the back and I

want to say congratulations for all your hard work. Please remember we work

together as a team and if you have ideas about how we could improve our per-

formance I would be really pleased if you contacted me. The numbers of pa-

tients we have entered into studies in 2009 have increased significantly from

the numbers in 2008. Let’s continue to increase those numbers in 2010.”

Best wishes to you all

Warren

In this

edition……

An update on the

West Midlands Young Per-

sons Group.

Band 7 Senior Clnical Re-

search Nurse Vacancies at

Birmimgham Children’s and

North Staffs Hospitals.

Details further on how to

apply.

A summary of the success-

ful CASCADE Trial

An informative table of

trial activity.

Staff News.

WM-MCRN—The Team

Trial News • PUDDLS (Paediatric UK Demyelinating Disease Longitudinal) is the first study adopted by West Midlands

MCRN studying Multiple Sclerosis. The target is 12 per year at BCH and we have recruited 2 patients in the

first two weeks of the study opening!

• The University Hospital of North Staffordshire is at the moment the 2nd highest recruiter to the MASCOT

(Management of Asthma in School Age Children on Therapy) study with 12 patients, 6 of those are ran-

domised.

• The CHiP (Control of Hyperglycaemia in Paediatric Intensive Care) trial has recruited its 100th patient at

Birmingham Children’s Hospital. Well done to all those involved!!

• MOR – 002 (Biomarin) - Phase 1/2 Safety and efficacy investigation of a new enzyme replacement therapy

in children’s with Morquio Syndrome. Eight patients have been recruited to this study so far, exceeding the

recruitment target by three.

On the 28th October 2009 the children and young people of the West Midlands MCRN Young persons Group were

visited by the Communications Officer and PPI lead from the Medicines and Healthcare Products Regulatory

Agency (MHRA). Children and young people had the opportunity to learn about how medicines in the UK are regu-

lated before they are fit to be given to patients.

After learning about this process members of this group were then asked to give their opinions with regards to

early access to medicines in different circumstances, at the end of a phase 2 trial, instead of waiting until the

end of the trial.

All the young people in the advisory group gave their opinions and came up with some fantastic and thought pro-

voking questions and thoughts. The MHRA were extremely impressed and interested in the responses of the chil-

dren and young people. Following this session and two others hosted by the Liverpool and Trent MCRN young per-

sons group the MHRA will compile a report which will include all of these questions and opinions. This report will

be sent to the Secretary of State for Health, The Right Honorary Andy Burnham MP.

This is a very important piece of work that the children and young people have taken part in and we hope to hear

some feedback from the MHRA in due course.

Since this date the children have had a follow up meeting and have been learning about all aspects of the re-

search cycle from the research question to dissemination of research findings. They have helped a research fel-

low at Aston University looking at formulations and will soon be commenting on another proposed study with a

PICU research fellow.

If you are a researcher or have any aspects of research that you think the group could help you with then please

contact us. We have meetings in January, March and May and every two months thereafter. If you have any fur-

ther questions or want to know more about the group please do not hesitate to contact us:-

claire.callens@bch.nhs.uk 0121 333 8739 or carly.tibbins@nhs.net 01782 662579

Medicines and Healthcare Products Regulatory Agency (MHRA) Visit – West Midlands

MCRN Young Persons Group

Job Title: Senior Clinical Research Nurse

Salary: Band 7

Location: 1 position vacant at Birmingham Children’s Hospital NHS Trust

1 position vacant at University Hospital of North Staffordshire NHS Trust

Hours: 1.0 WTE (37.5 hours/week) – part-time will be considered for the Birmingham position

0.6 WTE (22.5 hours/week) for the North Staffordshire position

Contract: Permanent

Closing Date: 29th January 2010

Interview Date: 17th February 2010 for Birmingham position

18th February 2010 for North Staffordshire position

If you are a registered paediatric nurse (RSCN or RN (Child)) or a registered nurse (RN) with paediat-

ric experience and you are looking for a new challenge, then this is an exciting opportunity to develop

and expand your skills and knowledge in research and team management.

An exciting opportunity has arisen for an enthusiastic, innovative and motivated nurse to play a key role

in the West Midlands Medicines for Children Research Network. The WM-MCRN is one of 6 local net-

works that have been established to facilitate a broad range of research projects looking at children’s

medicines. We are seeking to appoint a Senior Clinical Research Facilitator (CRF) to manage a team of

research facilitators who are based in either Birmingham or Stoke and cover a number of NHS sites

across the North and Central West Midlands.

You should be an adept communicator with the ability to engage and motivate others and a flair for posi-

tively influencing people. A good working knowledge of research processes, regulatory requirements and

research governance is essential, along with previous experience of managing a team. Experience of fi-

nancial resources would be beneficial. You will be expected to manage your own workload and support

the team to carry out their caseloads of clinical trials and other research studies.

Please apply to either job via jobs.nhs.uk, quoting job reference 284-PK540-09 for Birmingham

Children’s Hospital and quote job reference 284-PK-541-09 for North Staffordshire.

To discuss either of the two jobs informally, please call Sam Hayton (Network Manager) 0121

333 8749 or 07919110257 or Prof. Warren Lenney (Network Director) on 01782 662579

WEST MIDLANDS JOB VACANCY

2009 saw the successful completion of the CASCADE study at UHNS. The recruitment target of

26 was reached. This trial is also running at Heartlands, Worcester and Burton and they are well on

the way to achieving their targets.

What is the purpose of the study?

Managing diabetes within a full and active life is challenging for children, young people and families.

Learning to adapt to this condition and sharing increasing responsibility with their parents can be

difficult to balance alongside additional peer pressure from friends who have more flexible life-

styles.

This study is to look at an alternative approach to supporting patients and parents during their clinic

visits, by bringing children and young people of similar ages together, with their parents, to motivate

them to adapt their insulin dosage, eat normally and manage other day-to-day challenges such as

exercise and illness.

It is important to know whether this alternative approach is helpful for all young people with

diabetes, and whether its results are sufficiently good for the NHS to recommend it. Can it be

delivered in busy clinics across the country and is it acceptable to patients and their families?

Twenty-six diabetes clinics across England and 520 children and young people, aged 8-16, and their

families, will be able to take part in the trial. The trial will be able to draw confident conclusions

about the effects on control of diabetes (measured by HbA1c) and other outcomes including patient

management of diabetes and use of health services, their health related quality of life, and psycho-

social well-being. Patients, families and clinic staff will also be asked their views about patient

education, and economists will assess the costs.

Congratulations

Well done to Dr Raffeeq, the PI at UHNS and to Marie Phipps, our MCRN Research Facilitator.

Vicki Strange the Senior Research Officer has commented “The support from Marie Phipps at

North Staffordshire Hospital has been invaluable. This site was one of our first to reach their re-

cruitment target . This is a direct result of her commitment and skills when working with patients,

the diabetes team at the hospital and with the central CASCADE research team in London.”

A great example of how MCRN can assist in speeding up clinical trials to completion thereby

benefiting children quicker in the long term

Thanks also to the Outpatients Team for their help and assistance.

CASCADE

Child and Adolescent Structured Competencies Approach to

Diabetes Education

StaR Child Health Conference

Last October Sam, accompanied by three of the team, attended the first Star Child Health Confer-

ence in Amsterdam. Star Child Health is part of the International Forum of Standards for Research

with Children, who is trying to develop standards/guidance for conducting paediatric trials.

StaR Child Health is a group of methodologists, clinicians and policy makers who seek to enhance the

quality, ethics and reliability of paediatric clinical research by promoting the use of evidence-based

standards or guidance for clinical studies with children. Sam was subsequently invited to join the

"Recruitment and informed consent" development group, assisting in the development, dissemination

and implementation of evidence-based standards for recruitment of children into

clinical research studies.

West Midlands MCRN Trial Activity (Open and in Set-up)

Acronym Area of Interest Status LRN Sites

AdDIT Diabetes and Endo-crinology

Open BCH

BOOST Neonatal Open UHCW, Birmingham Women’s, Russells Hall

New Cross, Shrewsbury Royal Hospital

CASCADE Diabetes and Endo-crinology

Open Heartlands, Burton, UHNS

CASG 112 Immunology In Setup Heartlands

CHARMS II Rheumatology Open BCH

CHIP (PICU) Anaesthesia Pain and PICU

Open BCH

UHNS

DETEMIR VS GLARGINE

Diabetes and Endo-crinology

Open BCH

DIONE (Tibotec HIV) Immunology Open Heartlands, UHNS

DUCHENNE (Heart Pro-tection)

Neurology In Setup RJAH Oswestry

Heartlands

Easai Epilepsy (Perampanel)

Neurology Open UHNS,

Elaprase Hunter Metabolic Diseases Open BCH

EUROWILSON Hepatology Open BCH

GAS Anaesthesia Pain and PICU

In Setup BCH

Glutamine in CF Respiratory Open Heartlands

H IVAT Respiratory Open BCH,UHCW, New Cross, UHNS

ICISS Neurology Open BCH, UHNS, Burton, Walsall, Russells Hall,

City and Sandwell, Warwick, Alexandra (Redditch), Hereford, Shrewsbury and Telford

Worcester, Staffordshire General

ICS/LABA Respiratory Open UHNS

I2S2 Neonatal In Setup Birmingham Women’s

JUMP Diabetes and Endo-crinology

Open BCH, Heartlands, Walsall Manor, Hereford, UHCW, UHNS

KICk OFF Diabetes and Endo-crinology

Open BCH

Hereford

Lysosomal Storage Dis-order

Metabolic Disorders Open BCH

MAGNETIC Respiratory Open BCH, Heartlands, UHNS

MASCOT Respiratory Open UHNS, UHCW

MENDS Neurology Open BCH

MIND Neonatal In Setup Birmingham Women’s

MOCA Diabetes and Endo-crinology

Open BCH

UHCW

MOR – 001 Metabolic Disorders Open BCH

MOR – 002 Metabolic Disorders Open BCH

Mundipharma Anaesthesia, Pain and PICU

Open BCH

MYCYC Vascular Open BCH

NFS Diabetes and Endo-crinology

Open BCH

Heartlands

PALF Hepatology Open BCH

P3MC Neurology In Setup BCH

PIANO (Tibotec HIV) Immunology Open Heartlands

POP Rheumatology Open BCH

RaDaR Renal In Setup BCH

Recruit General Paediatrics Open UHNS

Roche Tamiflu General Paediatrics In Setup BCH, Walsall Manor, Heartlands, Sandwell,

City, Shrewsbury Royal, Princess Royal Tel-ford, Burton, UHNS, Worcester

SCO BIA Neurology Open BCH

SLEEPS Anaesthesia, Pain and PICU

In Setup BCH

TAPS Haematology Open BCH

Tiotropium Respiratory Open New Cross

Heartlands

UK JSLE Cohort Rheumatology Open BCH

PUDDLS Neurology Open BCH

West Midlands MCRN Trial Activity (Open and in Set-up)

Staff News

New Starters

Katharine Beamond joined us at the end of August last year. She graduated from Keele University

in 2007 having attained a BN (Hons) with First Class Honors in Children’s Nursing. Since qualifying,

Katharine has worked within Trauma, Orthopaedics and Acute Paediatric Care. Katharine first

became interested in research whilst in the University setting and is delighted to be working for

MCRN based at the University Hospital of North Staffordshire.

Rachel Jackson joined the team in November 2009, having previously worked as a Research Nurse in

the Wellcome Trust Clinical Research Facility at Birmingham Children’s Hospital. She graduated 10

years ago with a BA (Hons) in Paediatric Nursing and has spent 8 years working in neonates surgical

care in Birmingham Children's and the special baby care unit at Good Hope Hospital. Rachel will

specialise in supporting neonatal studies at units across the Central West Midlands.

Leavers

We are sorry to lose Mark Smith, one of our CRF’s in Birmingham Children’s Hospital. He is leaving

at the end of January to take up a lecturer post at Birmingham City University, teaching pre-reg

staff nurses, nursing practice and will also work in PICU in Birmingham Children’s Hospital.

Promotions

Congratulations to Jacqui Daglish who was promoted to Band 7 Senior Clinical Research Facilitator

in August. She is based at University Hospital of Coventry where she looks after the South of the

West Midlands in her Band 7 role and also co-ordinates the training database for all nurses in the

West Midlands region.

WM-MCRN—THE TEAM

Professor Warren Lenney Dr Kevin Morris Dr Heather Stirling

Network Director/Clinical Lead North Clinical Lead Central Clinical Lead South

Dr Sam Hayton Mandy Aspinall Jacqui Daglish

Network Manager Senior CRF Central Senior CRF South

Claire Callens Carly Tibbins Gemma Slinn

User Involvement Co-ordinator User Involvement Clinical Trials

Co-ordinator Co-ordinator

Hilary Shepley Marie Phipps Katharine Beamond

CRF North CRF North CRF North

Sarah Reynolds Kristina Lum Kin Gerri Mulcahy

CRF Central/South CRF Central PA/Administrator

North

Tracey Kirkwood Emily Benson Charlene Gallagher

Joint MCRN/Wellcome CRF CRF Central PA/Administrator

Central Central

Fiona Thompson Karen Miles Cathy Foreman

CRF South MCRN MASCOT Nurse Network Support Officer

Individual email addresses can be found on the website as below.

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.