Interview: Delivering smart clinical trials for better health

Following the launch of Protas, an organisation which was launched on January 24, 2022, DDW Editorial Assistant Megan Thomas interviews Protas Chief Executive, Professor Sir Martin Landray, an epidemiologist and physician who has over 20 years’ experience of leading large, randomised clinical trials and has most recently been leading the landmark RECOVERY clinical trial into treatments for Covid-19. MT: What is Protas offering that is different? ML: We have established Protas as a not-for-profit company to address the need for large-scale randomised clinical trials of treatments for diseases with major public health impact. We have seen our approach work in areas such as cardiovascular disease, kidney disease, diabetes, and Covid-19, exemplified by clinical trials that we have been leading at Oxford University over the last few decades. We have shown that it is possible to produce high quality results at around one-tenth of the cost and with that in mind, we want to scale and diversify across diseases and to enable the efficient evaluation of promising treatments that are emerging from universities as well as small and large companies. Our approach to trials combines smart protocol design, collaborative partnerships, and careful use of data and technology. We focus on what’s needed to produce a compelling answer to a relevant public health question, work with the NHS and other health organisations, industry, and patient groups, and develop and deploy software systems to drive cost-effective, high-quality trial delivery. We will create a new trial management platform that combines all the proven qualities of the systems previously developed at Oxford with the opportunities now provided by modern software engineering, data management, and computer science. MT: How do you view the clinical trial market as it stands? What are the challenges and opportunities? ML: The cost of developing a new drug is extortionately high. A very large part of that cost is the last trial you need to conduct before you get drug approved. In many cases, this single trial can cost in excess of $1 billion. It is worth reflecting that the first large trials of treatment for acute heart attack in the 1980s cost less than $10 million in today’s money. The quality of those trials and their impact on health then was similar, if not greater, than it is now, yet the costs are now around 100-times higher. That’s a market failure and a disaster for efforts to tackle the burden of ill-health. The implications of these challenges are huge: many exciting new drugs are never taken forward because they are simply not worth the commercial risk; those that are taken forward are often inadequately studied with trials being too small, too short, or in only very selected patients; and when the trials are done and the drugs are brought to market, the costs are high not because of the cost-of-goods but because of the cost of the R&D and most specifically the cost of the late phase clinical trial. The opportunity – which we’re addressing through Protas – is to change the economics of those late-stage trials so that pharmaceutical companies feel they are able to make more bets on treatments for common diseases, which ultimately creates better health outcomes for patients and reduces the burden on the health systems that support them. MT: How has your experience with the RECOVERY trial informed the setup, or goals of Protas? ML: The pandemic has shown us that big, randomised trials are critical for understanding which treatments work. For example, we wouldn’t have known whether dexamethasone worked without the RECOVERY trial and several lives have been saved as a consequence. On the flipside we looked at hydroxychloroquine, which had a number of very high-profile advocates and was being used very widely, and found there to be no beneficial effects for patients with severe Covid. So during the pandemic, trials made the difference. But Covid-19 is not special in that respect, we have many common conditions that cause ill health and put a real strain on the health system. We need better treatments for those conditions too and that is why we have setup Protas. MT: Why do you think the work that Protas is planning to do is important? ML: If you consider the major health threats affecting the global population, they are largely common diseases affecting people in late middle and old age. This impacts individuals, the health services that support them, as well as wider society. For example, the NHS struggles every winter due to large numbers of patients with multiple long-term health conditions who suffer an illnesses such as a chest infection, hip fracture, or flu. We hope that through the trials delivered by Protas, better and more affordable treatments can be developed to tackle some of those common conditions and improve outcomes for patients. MT: Where do you see the company in five years? ML: I’d hope that in five years we will be partnering with several biopharma companies, designing and delivering multiple Phase III clinical trials – and making a real difference to patient health outcomes and reducing the burden on health systems around the world. I’d also like us to have improved the delivery of clinical trials across the board by demonstrating that there is a way of delivering high quality, low-cost clinical trials through smart design, partnership and technology. Image credit: John Cairns Biography Sir Martin Landray is CEO of Protas, Professor of Medicine and Epidemiology at the University of Oxford and a consultant hospital physician. He has over 20 years’ experience in leading large, randomised trials and is a joint lead of the RECOVERY trial of treatments for Covid-19. He works closely with regulators, industry, academia, patient groups and government organizations to improve all aspects of clinical trials.