Duke Clinical Research Institute (DCRI), the world’s largest academic research organization, will collaborate with Protas, a not-for-profit clinical trials organization led by renowned Oxford University clinical trialist Professor Sir Martin Landray to develop new approaches to large randomized clinical trials and enable better evidence-based treatments for common conditions, such as heart and kidney disease, hypertension, diabetes, stroke and COVID-19.
DURHAM, North Carolina, US; LONDON, UK, Wednesday 1 March 2023: Duke Clinical Research Institute (DCRI), part of the Duke University School of Medicine in the US, and Protas, a not-for-profit clinical trials organization based in the UK, today announce a long-term collaboration to transform clinical research by radically altering the way clinical trials are designed and delivered to better meet the needs of patients and society.
Building upon DCRI’s longstanding history of innovative research and Protas’ smarter approach to large-scale randomized clinical trials, the organizations aim to accelerate the discovery of state-of-the-art medicines and the better use of treatments to improve public health outcomes globally.
DCRI and Protas will focus the collaboration on four key areas:
- Co-developing and delivering exemplar large randomized clinical trials to generate high-quality evidence in areas of major disease burden including, but not limited to, cardiovascular, metabolic, kidney, gastrointestinal and respiratory disease as well as common and emerging infections.
- Increasing the diversity and inclusion of trial participants around the world through partnership with patient groups and the clinicians and healthcare institutions they attend
- Establishing novel trial designs and methods (including effective, trustworthy use of data and technology) to enable low-cost, high-quality, large randomized trials.
- Developing and advocating the implementation of fit-for-purpose clinical trial policies to encourage and facilitate high quality randomized trials that address the needs of patients and the public.
DCRI is the world’s largest academic clinical research organization.
“This collaboration holds great promise,” said Adrian Hernandez, MD, Executive Director of DCRI. “DCRI and Protas have a shared commitment to, in the short term, define a framework to organize, prioritize and work together on particular areas of opportunity while in the longer term co-developing and/or co-executing global clinical trials or related research opportunities. We are looking forward to working with Protas on key projects as well as changing policies and practices to have a major impact on the health of patients around the world.”
Protas was launched in 2021 and is led by the epidemiologist and physician, Professor Sir Martin Landray, who has over 20 years’ experience of leading large, randomized clinical trials as part of a team at Oxford University’s Nuffield Department of Population Health. Most recently, he has been leading the landmark RECOVERY clinical trial into treatments for COVID-19, which identified that treatment with the inexpensive steroid drug, dexamethasone, improved the chances of survival for the most severe cases.
Sir Martin Landray, FMedSci, said: “This important collaboration with DCRI will seek to transform the way trials are designed and delivered globally. In recent decades, high-quality clinical trials have become costly and inefficient, leading to fewer innovative treatments for diseases that affect a large proportion of the population. Working with DCRI, we aim to drive widespread change in the clinical trials sector by designing smarter and more cost-effective trials, improving healthcare inequalities, and addressing key issues in the policy and regulatory environment. DCRI’s track record speaks for itself, and we look forward to working with the team to demonstrate what the future of clinical research and trials could look like.”
About Protas
Protas is a not-for-profit organization, dedicated to designing and delivering smart, large-scale and global clinical trials on treatments for common and other life-threatening diseases. By improving the quality and substantially reducing the cost of large randomized clinical trials, Protas will encourage the development of more treatments for common and other life-threatening diseases, with profound implications for patients and the health systems that care for them.
Protas represents a radical leap forward in the way that clinical trials can be conducted and will enable earlier access to better treatments for common and other life-threatening conditions. It will do this through:
- Unparalleled knowledge and expertise: The organisation is led by Professor Sir Martin Landray, Professor of Medicine and Epidemiology at Oxford University and co-founder of the RECOVERY trial, the world’s largest trial of treatments for COVID-19. Protas is overseen by a highly respected Board, with a long track record in drug development, clinical trials and the life sciences.
- A smarter approach in design and delivery: Protas will minimize complexity and cost by designing trials that focus on the needs of the participants in the trial and those future patients whose care will be impacted by the results. Protas will use technology to enhance trial quality and efficiency, including through trustworthy use of healthcare data. Protas will collaborate with clinicians and patients to ensure trials are designed to be practical, accessible and scalable.
- A business model that is aligned to public health benefit: Protas is a non-profit organisation allowing it to keep focus on the stated aims of clinical trial efficiency, affordability, accessibility and quality.
More information can be found at https://protas.co.uk.
About Duke Clinical Research Institute
DCRI conducts innovative research to deliver on its mission to share knowledge that improves health around the world. DCRI projects are led by physician scientists whose grounding in patient care helps to inform their research, and supported by staff who have deep expertise in operationalizing global studies.
As an academic clinical research organization, the DCRI unites the clinical expertise and academic leadership of a premier teaching hospital with the capabilities of a full-service contract research organization. Thus our teams of faculty and operational experts provide the independence, scientific leadership, and collaborative approaches to look at research challenges differently:
- Our researchers include practicing physicians who implement trials that are grounded in the realities of clinical care.
- Our experienced teams deploy nimble and responsive operational approaches.
- We offer the best-in-class statistics, informatics, and quantitative science.
- We have extensive knowledge of local clinical practice patterns and regulatory requirements, both across the United States and worldwide.
More information can be found at https://dcri.org.