The VALIDATE Programme of Research
Research type
Research Study
Full title
InnoVative ObservAtionaL In-vitro DiAgnosTic pErformance study (VALIDATE) A complex innovative design study to enable the development, assessment, and analysis of evidence required to establish or verify the scientific, analytic, and observational clinical validity of in vitro diagnostics.
IRAS ID
316052
Contact name
Timothy Felton
Contact email
Sponsor organisation
Manchester University NHS Foundation Trust
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
The VALIDATE Programme of Research is an innovative single-site study sponsored and hosted by Manchester University NHS Foundation Trust (MFT) which aims to facilitate efficient and collaborative performance evaluations of medical tests, known as in vitro diagnostics (IVD).
Around 70% of clinical decisions are influenced by IVDs despite comprising less than 1% if NHS England’s budget. This highlights their current importance and suggests room for future impact, particularly as the NHS moves towards a model emphasising diagnosis, prevention, and prediction.
Clinical studies of new IVDs share many design components which VALIDATE brings together under one complex innovative design known as a programme of research. In VALIDATE, IVD performance is evaluated in an observational manner using samples collected from patients. The IVD result is compared to tests done as part of standard care but is not used to influence care.
VALIDATE comprises a master protocol and a series of sub-studies added as the programme progresses. Each sub-study is conducted under its own sub-protocol and delivered by its own sub-study team. VALIDATE is neither IVD nor disease specific, enabling the evaluation of IVDs across specialties. Each sub-study is delivered independently whilst benefiting from the resource efficiencies of a pre-existing programme, with shared governance and operational oversight.
In the UK, 97% of IVDs are developed by small/medium-sized enterprises (SMEs). These SMEs often lack experience conducting research in the NHS and VALIDATE enables them to access NHS research infrastructure. VALIDATE will therefore help achieve the government’s life sciences vision as an example of a collaborative programme in the evaluation of diagnostics.
By conducting IVD research in a way which emphasises efficiency and collaboration, it is hoped that novel IVDs will emerge sooner, with high quality supporting evidence and clear use cases to help meet current and future challenges faced by the NHS.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
24/YH/0009
Date of REC Opinion
18 Jan 2024
REC opinion
Favourable Opinion