Professor Martin Landray will lead an initiative to develop new good practice guidelines for clinical trial regulation.
Wellcome has established the Joint Initiative on Good Practice in Clinical Research with the Gates Foundation and the African Academy of Sciences to develop new clinical research guidelines.
Professor Landray said: “I am delighted to have the opportunity to lead this exciting initiative to develop and promote a new approach to clinical trial regulation.”
He added: “Clinical trials are the bedrock of safe and effective treatment, but over recent years have become unduly expensive and burdensome to conduct, threatening the ability to develop new treatments. New guidelines must be forward-looking and foster innovation, whilst remaining true to the underpinning scientific and ethical principles.”
“This is an exciting time for clinical trials – widespread adoption of electronic healthcare records and advances in digital technologies provide unprecedented opportunities to transform their quality and efficiency. It is essential that guidelines embrace these new approaches whilst maintaining focus on the key quality issues that materially impact the wellbeing of trial participants and the reliability of the results, which influence the care of future patients.”
The new guidelines will be co-developed in an Open Regulatory Science approach with people from across the clinical trial enterprise, including regulators, funders, academic and commercial trialists, clinicians, patients and the wider public. They will seek to be broadly applicable across disease areas, health interventions, patient populations, and geographies. Particular attention will be paid to the emerging health challenges of the coming decades including genomic medicine, drug resistant infection, communicable disease outbreaks, and the chronic degenerative disorders of middle and late-age.
Once the guidelines are established, the initiative will advocate for their adoption by policymakers, regulators, international standards bodies and those responsible for funding and conducting clinical trials worldwide.
Professor Landray is a Senior Research Fellow at Green Templeton College and Director of Health Data Research UK, Oxford.