VALIDATE – sample platform study

Adaptive platform studies allow multiple clinical studies testing different health technologies to be carried out under one over-arching protocol.

VALIDATE (innoVative observAtionaL In-vitro DiAgnosTic pErformance) has been developed and launched by the NIHR HealthTech Research Centre in Emergency and Acute Care as a sample platform study, to provide a streamlined process for academics, clinicians, and commercial companies to access patient samples and data. The platform study has a broad scope – not being disease or infection specific.

Why VALIDATE is needed

One of the main challenges in carrying out innovative research is gaining access to patient samples for pre-clinical testing, or clinical validation and evaluation studies.

One of the aims of the HealthTech Research Centre in Emergency and Acute Care is to make patient samples more accessible, allowing innovators to generate the evidence required to demonstrate feasibility, and accuracy of new diagnostics at a faster pace, bringing benefits to patients sooner.

Successful platform studies

This approach means that if a new diagnostic needs testing within a clinical setting, instead of setting up a new study each time, which involves lengthy ethics applications and document development, new potential interventions and treatments can be added to the platform as required – under the same master protocol and ethical approval – allowing for greater flexibility and pace than is possible with traditional clinical studies.

The COVID-19 pandemic accelerated the development and implementation of platforms, including the RECOVERY trial. 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 COVID-19 National DiagnOstic Research and Evaluation (CONDOR) trial was run via a platform model, which allowed researchers to quickly create a single, national route for evaluating new diagnostic coronavirus tests in hospitals and in community healthcare settings. CONDOR evaluated more than 30 COVID-19 tests that are now widely used by the NHS and in homes.

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.