WHAT NCTU CAN DO FOR YOU

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(No Transcript)
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WHAT NCTU CAN DO FOR YOU!

• Dr E McColl, Director, NCTU

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The Newcastle Clinical Trials Unit

• The NCTU has been established to support the
  conduct of a broad spectrum of clinical and
  complex trials across all sectors of the health
  service-
• Pharmacological interventions
• Surgical interventions
• Screening programmes
• Patient education and behaviour change
  interventions
• Service organisation interventions
• Professional behavioural change interventions
• High quality training in trial-related issues,
  including GCP, will also be provided, in
  collaboration with the CRC Education and Training
  Group.

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The remit of the NCTU

• Our remit is the design, conduct and analysis of
  RCTs, and other high quality studies
• With respect to conduct, our focus is on
  sponsor-level activities, project and data
  management
• To this end, we implement systems and procedures
  to ensure compliance with ethical, regulatory and
  research governance guidance and legislation

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Site level functions

• Site-level functions and activities are supported
  by the Clinical Research Centre platforms
  (Clinical Research Facility, CARU, Cancer
  Research Facility, Immunotherapy Unit, MR Centre)
  and Local Research Networks (LRNs)

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Key stages in conducting an RCT

• Bright idea / funding opportunity identified
• Study designed proposal written
• Funding obtained
• Detailed protocol developed from proposal
• Appropriate approvals and authorisations sought
• Study conducted
• Findings reported study close-down

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Identification of bright idea / funding
opportunity

• NCTU will-
• Work closely with University of Newcastles
  Business Development Directorate
• Scan databases and mail-base alerts for funding
  opportunities
• Alert researchers to relevant opportunities
• Be available for consultation by researchers for
  own initiative applications to funding bodies

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Designing the study and writing the proposal - 1

• NCTU will assist with-
• Refinement of research question
• Choice of most appropriate study design
• Trial design
• Inclusion of economic evaluation?
• Inclusion of qualitative component?
• Development of selection and sampling strategies
• Power calculations
• Choice of most appropriate outcome measures

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Designing the study and writing the proposal - 2

• NCTU will advise on and assist with-
• Ethical issues
• Feasibility issues
• Resource requirements
• Costing the proposal
• Role and membership of TSC and DMEC
• Writing and presenting the proposal to funders

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Appropriate approvals and authorisations sought -
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• NCTU will carry out (with CI input)-
• Preparation of full study protocol
• Application to MHRA
• Registering study with EUDRACT
• Preparation submission of CTA application
• Application for ethical favourable opinion
• Preparation of PIS and Consent Forms
• Completion submission of REC / SSI forms

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Appropriate approvals and authorisations sought -
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• NCTU will carry out (with CI input)-
• Application for Trust RD approval
• Completion of SSI RD Forms
• Obtaining honorary NHS contracts as required
• Preparation of protocol amendments as required

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Conducting study - 1

• NCTU will advise on and assist with-
• Development implementation of randomisation
  strategy
• Patient recruitment and retention
• Design of
• recruitment and retention strategies
• Informed consent procedures
• (Actual patient recruitment assessment will be
  a site-level activity, managed through study
  platforms and LRNs)

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Conducting study - 1

• NCTU will support-
• Adverse event monitoring and reporting
• Ensuring that requirements for MHRA / ethics /
  research governance are complied with
• Designing and implementing appropriate systems
  for monitoring and reporting

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Conducting study - 3

• NCTU will carry out-
• Training trial personnel in implementation of
  study protocol procedures
• Monitoring of sites performance
• Data management
• Design of CRFs, questionnaires, diaries etc
• Database design
• Data validation

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Conducting study - 4

• NCTU will carry out-
• Statistical analysis
• Organisation of TSC and DMEC meetings
• Progress reports to-
• Funding body
• MHRA ethics committees
• Participating trusts

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Reporting findings and study close-down

• NCTU will assist with-
• Preparation of final report to funding body
• Preparation of papers and other outputs for
  journals conferences
• Project close-down reports to MHRA, ethics
  committees and trusts
• Data archiving

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How you can help us - 1

• Alert us to your research interests and areas of
  expertise
• Think creatively about exploiting national and
  international opportunities
• Seek help early contact us as soon as the
  research idea arises or the call for proposals is
  issued

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How you can help us - 2

• You are the clinical and content area expert, and
  this expert input to development of proposal,
  full protocol and all other documents is
  essential
• Our expertise is in other aspects of trial design
  and conduct we ask that you respect that
  expertise as we respect yours

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Making contact

• All enquiries should be addressed to the CTU
  secretary, Cheryl Wiscombe
• E-mail cheryl.wiscombe_at_ncl.ac.uk
• You will be assisted to fill out a form regarding
  your needs
• A meeting will be arranged with the most
  appropriate representatives of NCTU to address
  your needs
• If appropriate, you will also be directed to
  other elements of the Clinical Research Centre
  (e.g. CRF, CARU) and/or to other experts (e.g.
  health economists, qualitative researchers)
  within the Institute of Health Society