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NIHR Medicines for Children Research Network (MCRN). Prof Ian Wong Chair, MCRN Pharmacy & Pharmacology Clinical Study Group Associate Director of London Local Research Network. Medicines for Children. Historically, limited numbers of paediatric clinical trials conducted

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Nihr medicines for children research network mcrn

NIHR Medicines for Children Research Network (MCRN)

Prof Ian Wong

Chair, MCRN Pharmacy & Pharmacology Clinical Study Group

Associate Director of

London Local Research Network


Medicines for children
Medicines for Children

  • Historically, limited numbers of paediatric clinical trials conducted

  • High proportion of off-label/unlicensed medicine use

  • Potentially leads to over/under dosing

  • Increased chance of adverse events

  • Requirement for:

    • More clinical trials in children

    • Better age-appropriate formulations

    • More authorised medicines and treatments


Eu regulation better medicines for children
EU Regulation “Better medicines for children”

  • 26 January 2007

  • Paediatric Investigation Plan (PIP) for all new MA’s and variations

    • Agreement with Paediatric Committee

    • Waivers and deferrals

    • 6 month patent extension

    • Information included in SmPC

  • PUMA (data protection)

    • for off-patent developments

  • Research on older drugs (7th Framework funding)

  • European Paediatric Research Network (EnprEMA)

More research on

paediatric medicines


Mcrn vision
MCRN - Vision

To improve children’s health and alleviate suffering through the provision of better and safer medicines.


Mcrn aims
MCRN - Aims

  • To provide the best infrastructure in the world to support studies which address the safety and efficacy of medicines for children

  • To provide an excellent base for clinical research for children, which is an attractive resource for the global pharmaceutical industry

  • To ensure that world-leading research addresses the needs of children


Mcrn adding value to study delivery
MCRN – Adding Value to Study Delivery

  • Large network supporting randomized and other studies of medicines for children in UK NHS sites serving approx 12 million children

  • Supporting:

    • All phases (I-IV)

    • All therapy areas (except oncology)

  • Studies supported (adopted) by MCRN

    • Publicly-sponsored

    • Industry-sponsored

    • Investigator-initiated (industry funded) Research (IIR)



Clinical studies groups csgs
Clinical Studies Groups (CSGs)

  • Key opinion leader advisory groups

  • Proactive Roles:

    • To identify research priorities within specialty areas

    • To propose and develop trial ideas and proposals

    • Representatives on MCRN Board provide strategic direction

  • Reactive Roles:

    • To work with investigators to develop study ideas to successful funding application

    • To provide subject specific and methodological advice to industry and other investigators (protocols, PIPs etc)

    • Representatives sit on MCRN Study Assessment Committee (SAC)


Clinical studies groups csgs1
Clinical Studies Groups (CSGs)

Allergy, Infection and Immunity Dr Mike Sharland

Anaesthesia, Pain, Intensive Care and Cardiology Dr Robert Tasker

Diabetes, Endocrinology and Metabolic Medicine Prof David Dunger

Gastroenterology, Hepatology and Nutrition Dr Nick Croft

General Paediatrics (including Dermatology) Dr Colin Powell

Inherited Metabolic Disorders (MCRN/UK LSD) Dr Chris Hendriksz

Methodology Prof Peter Brocklehurst

Neonatal (MCRN/Action Medical Research) Dr Mark Turner

Nephrology (MCRN/BAPN) Dr Moin Saleem

Neurosciences Dr Timothy Martland

Pharmacy and Pharmacology Prof Ian Wong

Respiratory and Cystic Fibrosis Dr Paul Seddon

Rheumatology (MCRN/Arthritis Research UK) Dr Michael Beresford


Balanced portfolio
Balanced Portfolio

Adopted studies (n=198; as of July 2010)



Local research networks lrns
Local Research Networks (LRNs)

LRN staff support the conduct of paediatric research in the NHS and work to Good Clinical Practice (GCP) standards

  • Director

  • Manager

  • Research Nurses

  • Pharmacists

  • Data entry staff

  • Administration


Feasibility
Feasibility

Feasibility request

<5 working days

Level 1 Feasibility

(Top level review by CSGs)

Level 2 Feasibility

(Investigator identification

by LRNs)

10 working days

Data sent to company

  • Additional company feasibility

  • (Investigators/LRNs)

  • Company specific CDAs

  • Full feasibility questionnaires


Clinical research facilities crfs
Clinical Research Facilities (CRFs)

  • Children’s CRFs facilitate the conduct of very complex/invasive studies, which might be impossible to perform elsewhere

    • Specialist Children’s Research Nurses and other staff

    • Advanced equipment, lab and other facilities

    • Purpose built for children

  • Close collaboration between MCRN and UK CRFs


Site setup
Site Setup

  • LRNs support:

    • Financing (NIHR CRN Costing template)

    • Local R&D/ethics approvals

    • Contracting (mCTA)

    • Staff contracting and recruitment

    • Training

      • All company employees working on adopted studies can attend free NIHR CRN/MCRN training courses

  • MCRN support helped sites setup an average of ~2 months earlier than other sites


Recruitment to target
Recruitment to target

  • LRNs support recruitment - strategy, staff support, new site identification

  • Recruitment continually monitored by MCRN Industry Team, LRNs and Executive

  • If site not recruiting as expected, investigator/site staff contacted to resolve issues


Industry successes
Industry Successes

“Congratulations on your first screened subject!!! This is excellent news and I can confirm that this is the first screened subject globally.”

Charlotte Vigor PhD

Study Manager, Clinical Operations

Takeda Global Research and Development (Europe) Ltd


Industry portfolio
Industry Portfolio

Adopted industry studies (n=98; as of September 2010)




Industry portfolio1
Industry Portfolio

Number of studies

Adopted

Number of

Children

Recruited


Conclusions
Conclusions

  • MCRN is committed to meeting recruitment targets for the both academic and pharmaceutical industry

  • The Network provides support during all study stages to ensure that targets will be met

  • Excellent recruitment to studies

    • Successful even in rare paediatric conditions

  • Positive feedback from companies


Nihr medicines for children research network mcrn

To discuss support that MCRN / Pharmacy and Pharmacology CSG can provide please contact:

Prof Ian Wong

ian.wong@dpp.pharmacy.ac.uk