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:
NIHR
- 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)
MRC
- Development Pathway Funding Stream (DPFS)
Charities
- 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
- The Newcastle upon Tyne Hospitals NHS Foundation Trust (NuTH) (https://newcastlejro.com/about/partners/)
- Cumbria, Northumberland Tyne and Wear NHS Foundation Trust (CNTW) (https://www.cntw.nhs.uk/about/research/)
- South Tees Hospitals NHS Foundation Trust (https://www.southtees.nhs.uk/about/teaching/research/)
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.