Newcastle Clinical Trials Unit

Clinical Trial Design

Clinical Trial Design

In conjunction with NIHR Research Design Service North East and North Cumbria 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
  • evidence synthesis/systematic review
  • 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 presenting the application to funders

We have experience of applying to the following funding streams:


  • Health Technology Assessment (HTA)
  • Efficacy and Mechanism Evaluation (EME)
  • Research for Patient Benefit (RfPB)
  • Programme Grant for Applied Research (PGfAR)
  • Fellowships
  • Invention and Innovation (i4i)
  • Public Health Research (PHR)
  • Health Service and Delivery Research (HS&DR)


  • Development Pathway Funding Stream (DPFS)


  • British Heart Foundation
  • Arthritis Research UK
  • Heart Research UK
  • Cancer Research UK
  • Diabectics Research UK

We also have experience of working on commercial Investigator Initiated Trials (IIT).

We work closely with the following sponsors

As a UKCRC Registered CTU based in England, and with a strong track record in winning funding from the NIHR funding streams managed through NETSCC, NCTU is in receipt of NIHR Clinical Trials Unit Support Funding, which provides pump-priming resourses.