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Sarah Avery

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DURHAM, N.C., LONDON, U.K -- Duke Clinical Research Institute (DCRI), part of the Duke University School of Medicine, and Protas, a not-for-profit clinical trials organization based in the United Kingdom, have launched a long-term collaboration to transform clinical research by altering the way clinical trials are designed and delivered to better meet the needs of patients and society.

Building on DCRI’s longstanding history of innovative research and Protas’ cutting-edge 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 exemplary large, randomized clinical trials to generate high-quality evidence in areas of major disease burden, including cardiovascular, metabolic, kidney, gastrointestinal and respiratory diseases, as well as common and emerging infections;

* Increasing the diversity and inclusion of trial participants around the world through partnerships with patient groups and the clinicians and health care institutions providing care;

* Establishing new 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.

“This collaboration holds great promise,” said Adrian Hernandez, M.D., executive director of DCRI, the world’s largest academic clinical research organization.

“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,” Hernandez said. “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 of experience 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.

“This important collaboration with DCRI will seek to transform the way trials are designed and delivered globally,” Landray said. “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 health care inequalities, and addressing key issues in the policy and regulatory environment,” Landray said. “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.”