Supporting Clinical Trials
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.
Clinical Trial Set-Up
We will work with you to set up clinical trials and studies:
- turning a proposal for funding into a full protocol
- developing consent forms and patient information sheets (PIS)
- feasibility
- risk assessments
- development of data capture forms and systems
- programming/set up of trial databases
- development and implementation of randomisation strategy
- acquisition of questionnaires
- development of trial-specific manuals of procedures and standard operating procedures (SOPs)
- development of trial-specific documentation (e.g. delegation logs, monitoring plans, data management plans)
- set-up of supporting departments and documentation required (e.g. Laboratory Manual, delegation logs)
- application for NIHR portfolio adoption
- application to MHRA, HRA/HCRW and Research Ethics Committee (REC)
- registering study with EUDRACT
- completing IRAS to apply for permissions and approvals
- registration of the trial on a publicly accessible database/register (e.g. ISRCTN)
- applications for other permissions and approvals as required
- set-up of Trial Master File (TMF)
- set-up of Investigator Site Files (ISF)
- liaison with trial sites, including international sites
- investigator meetings and site initiation
- Contract/agreement negotiation and approvals
- establish trial oversight committees (e.g. TSC, IDMC, TMG)
- training trial personnel
- green lighting of trial sites
Clinical Trial Analysis
We can facilitate the accurate analysis and reporting of a wide range of trials.
We work in close collaboration with researchers in the Newcastle University Population Health Sciences Institute:
- Biostatistics Research Group
- Health Economics
- Qualitative Researchers
Clinical Trials Conduct, Management and Monitoring
We conduct high quality trials and studies, through management and monitoring:
- amendment preparation and approvals
- patient recruitment and retention, including design of
- recruitment and retention strategies
- informed consent procedures
- ongoing communication with trial sites and investigators
- preparation of trial newsletters
- risk assessment review
- set-up and maintenance of trial web-sites
- maintenance of TMF and ISF
- adverse event monitoring and reporting
- ensuring that compliance with MHRA / ethics / research governance requirements
- designing and implementing appropriate systems for monitoring and reporting
- training trial personnel in implementation of study protocol and procedures
- all aspects of trial monitoring (central, off-site/remote and on-site monitoring)
- monitoring of supporting departments (e.g. Pharmacy, Laboratories)
- deviation and violation management
- database and data management
- database changes
- data queries and validation
- data downloads
- preparation and submission of progress reports and amendments to:-
- funding body / Sponsor
- MHRA
- Research Ethics Committees
- R&D departments in participating NHS trusts
- review and confirmation of recruitment data for NIHR portfolio
- in collaboration with Trial Statisticians
- prepare reports for Trials Steering Committee (TSC) and Independent Data Monitoring Committee (IDMC) meetings
- interim analyses as appropriate
- organisation of TSC, TMG and IDMC meetings
- project management
Clinical Trial Reporting and Close-down
We will work with you in managing all aspects of reporting and close-down:
- closedown of trial sites
- closedown of supporting departments
- database lock
- contribution to preparation of final report
- contribution to preparation of papers and other outputs for journals and conferences
- project close-down reports to funders, MHRA and research ethics committees
- End of trial declarations
- Trial Master File (TMF) archiving
- data archiving and preparation of data for sharing
- data anonymisation
- financial reconciliation
- dissemination of results to participants