Evaluation and Evidence Generation

Technology stage:  I have already demonstrated feasibility and/or have some clinical data.  I would like to generate evidence to support NHS (or other healthcare system) uptake and/or evidence required for regulatory purposes.

Our offering:

  • access to academic, clinical and industry collaborators and funding applications
  • support for funding and regulatory applications, and project management support
  • access to study design, regulatory, manufacturing, market access and health economics expertise
  • if your technology has regulatory approval, our clinical trials research unit can design a study to test against the current standard pathway;
  • if you do not have regulatory approval or wish to use outside of approved indication then we can also help to obtain the required approvals
  • opportunity for patients and the public to provide input for study design, to participate in clinical trials, and to disseminate study information

Supporting facilities:

Next steps:  Contact us on hrc-surgical@leeds.ac.uk to discuss your requirements.

Useful links

NHS DigiTrials – data services to support clinical trials.

NIHR Leeds Clinical Research Facility

NIHR Statistics Group

Medtech Early Technical Assessment (META) Tool

NIHR Innovation ObservatoryNICE will only consider reviewing a technology once it has first been through an initial filtering process managed by us at the NIHR Innovation Observatory.

Understanding Health Economics

NICE:  Evidence standards framework for digital health technologies

MHRA Guidance of Software

Clinical Trials Toolkit

Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension

Guidelines for clinical trial protocols for interventions involving artificial intelligence: the SPIRIT-AI extension