VALIDATE – Programme of Research
Programmes of research enable multiple clinical studies that test different procedures, interventions, or technologies, to be carried out under a single over-arching protocol.
VALIDATE (innoVative observAtionaL In-vitro DiAgnosTic pErformance study) has been developed and launched by the NIHR HealthTech Research Centre in Emergency and Acute Care to facilitate the evaluation of multiple In Vitro Diagnostics (IVDs) to support their development.
VALIDATE is a programme of research which provides a streamlined process for academics, clinicians, and commercial companies to access the clinical samples needed for evaluating the performance of a novel IVD. The VALIDATE programme has a broad scope – it is not specific to a single device or indication and can be used to evaluate IVDs across specialities.
Usually when a new diagnostic is evaluated in a clinical setting, a new study must be set up. This involves a lengthy ethics application and the development of specific study documentation. By adopting a programme approach, a diagnostic evaluation can be added as a sub-study to an existing programme with ethics approval, and documentation can be adapted from a series of pre-approved templates.
Why VALIDATE is needed
One of the key challenges in the development of new diagnostics is in gaining access to patient samples for pre-clinical testing and performance studies.
One of the aims of the HealthTech Research Centre in Emergency and Acute Care is to make patient samples more accessible to innovators. This will enable them to demonstrate the feasibility and diagnostic accuracy of new IVDs much faster and bring benefits to patients much sooner.
Innovative study designs
The innovative design of VALIDATE evolved from the innovative and adaptive study designs which accelerated our understanding of COVID-19 during the pandemic.
An innovative, adaptive platform study called RECOVERY quickly established an effective treatment for hospitalised patients that immediately changed clinical practice, giving the world its first breakthrough against coronavirus. Dr Tim Felton, Director of the HRC in Emergency and Acute Care, was a co-author of the research paper.
Similarly, the Manchester-led CONDOR study enabled researchers to create a single, national route for evaluating new COVID-19 diagnostic tests. CONDOR successfully evaluated more than 30 COVID-19 tests, transforming the UK’s testing capacity during the pandemic. The design of CONDOR led directly to VALIDATE’s programme of research design.
Since then, the Health Research Authority (HRA) have started a pilot to approve programmes of research and VALIDATE is a part of that programme. You can find out more about the HRA’s pilot here.
Work with us
If you are interested in finding out more about the VALIDATE sample platform, please complete the HRC enquiry form on the Contact Us page.