Evaluation and Evidence Generation

Technology stage:  I have already demonstrated feasibility and/or have some clinical data.  I would like to evaluate my innovation in a clinical environment and generate the relevant evidence to support NHS uptake

Next steps:  We can provide access to our clinical trials research unit for study design and management, access to our Surgical Technology Testbed, support with funding and regulatory applications, support for clinical efficacy and clinical validation, access to health economics services for surgical innovations, early procurement feedback

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 and regulatory expertise, and access to health economics expertise
  • if your technology has a CE mark, our clinical trials research unit can design a study to test against the current standard pathway;
  • if you do not have a CE mark or wish to use outside of approved indication then they 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

Useful links

A digital tool to make it quicker and easier to understand how medical device regulations apply to your product

NHS DigiTrials – data services to support clinical trials.

NIHR Imaging Clinical Research Facility

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

The patient reported outcome measures group

Guidance on planning a study and writing a protocol for their evaluation of a surgical technique or therapeutic device

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