Clinical trial standard looks to provides global benchmark

GCSA is supporting the UK clinical research industry by providing an internationally-recognised quality benchmark for sites focused on attracting commercial clinical trials to bring the most innovative treatments to patients.

Following the rapid approval of COVID-19 vaccines from both Pfizer-BioNTech and Oxford University/AstraZeneca, the UK’s ability to provide a world-leading regulatory environment both in terms of speed and robustness has been highlighted on the world stage, says GCSA. This, it says, coupled with the UK government’s January announcement to invest £213million upgrading the UK’s scientific infrastructure, positions the UK well for attracting pioneering medical research from around the globe. The company believes that the UK’s position is now further complimented by the development of GCSA’s site assessment, process improvement and evidence-based accreditation, designed to identify the highest performing locations in the UK.

The GCSA gold standard has been ratified by a Global Advisory Board of industry experts from a range of global and UK organisations. This evidences that participating sites are operating to the highest global standards and builds confidence for patients and clinical trial sponsors.

“GCSA will either enhance existing standards that some UK research centres have, or it will help improve and raise the standards of those centres that are trying to build their research capacity, thus allowing these UK centres to promote themselves as global competitors and attractive partners for clinical trials,” explains Simon Lewis, London North West University Hospital and GCSA Global Advisory Board member “Previously, there’s been no credible assessment or accreditation for research quality components. GCSA changes this.”

GCSA is committed to building capacity by improving, accrediting and maintaining quality of clinical research sites. This ensures high-quality patient and sponsor experiences whilst increasing the number of clinical trials. Following an investment of £7million of public money into just five NHS Patient Recruitment Centres (PRCs) in 2020, there is a real need for all UK based clinical sites to demonstrate and define their quality offering, bringing new treatment opportunities to patients and returning value to the public purse.

“Commercial clinical research is vital for UK Trusts as it provides cutting edge and often lifesaving treatments to patients, while generating revenue that can be used to improve services across the whole Trust,” explains GCSA Commercial Director, Max Pardo-Roques. “Helping sites to attract and then deliver more clinical research is a great benefit to patients and the wider NHS; the provision of a globally recognised benchmark will help sites to demonstrate this.”

Whilst clinical research is a highly-regulated industry, there are no established standards by which sites can demonstrate they are able to meet the expectations of patients and sponsors and until now there has been no way for sponsors to select clinical research sites based on clear quality standards independently assessed at the organisational level. GCSA sets this much-needed industry standard for research sites to strive for and achieve; allowing sites to evidence and communicate their capabilities and differentiate in a crowded and increasingly competitive marketplace. Beyond the assessment and accreditation process, where required GCSA will deliver individual, practical support on the areas for development to meet the standards and will work collaboratively with sites to achieve accreditation.

Image credit: Bill Oxford




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