Newcastle Clinical Trials Unit

Trial Development

Clinical Trial Development

We can help you to develop a clinical trial.

In conjunction with NIHR Reseach Design Service North East we can assist with:

  • identifying the appropriate funding stream(s)
  • refinement of research questions
  • choosing the most appropriate study design
    • trial design
    • including an economic evaluation component
    • including a qualitative component
  • development of participant selection, strategies and sampling
  • choosing the most appropriate outcome measures
  • planning for compliance with regulatory and governance requirements
  • guidance on ethical issues
  • guidance on feasibility issues, in collaboration with the NIHR Clinical Research Networks
  • IMP procurement, including referral to NHS Trust pharmacy and procurement services
  • advice on resource requirements
    • distinguishing between research, NHS support and treatment costs
    • costing the proposal, in collaboration with University and NHS Trust finance colleagues
    • planning and scheduling study timelines and milestones
  • advice on the role and membership of Trial Oversight Committees
    • Trial Steering Committee (TSC)
    • independent Data Monitoring and Ethics Committee (DMEC)
  • advice on presentating the application to funders