A coin toss decides which patients get a new treatment and which get a dummy pill in large-scale trials for heart disease, diabetes, and kidney disease. This matters because even modest improvements in common diseases save thousands of lives, but only if the evidence is rock-solid. Small, unreliable trials have often led to treatments that later proved useless or harmful. The researchers have pioneered a way to run massive randomised trials cheaply and efficiently, using IT and central health records to track outcomes without the usual administrative drag. If this approach succeeds, it could transform how the NHS and other health systems test new drugs. Instead of years of slow, expensive recruitment, trials enrolling tens of thousands of patients could become routine. Ongoing studies include testing a cholesterol-lowering drug added to statins for high-risk patients, a new kidney disease treatment, and an established medication to slow diabetic eye disease. The direct impact would be faster, cheaper answers on which treatments actually work—and which do not—for the conditions that fill hospital wards every day.
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The aim of this programme is to demonstrate reliably any benefits of treatments that can be widely used in common diseases such as heart disease, diabetes and kidney disease. Even quite modest improvements in outcome in common conditions can lead to important benefits for patients. In order to be sure that treatments really work, large numbers of people usually need to be given the treatment and compared with similar people not given the treatment. The most reliable way to do this is using randomisation, a method whereby the decision about who receives a treatment is determined by chance (like tossing a coin). In order to help provide reliable results, these randomised trials also often involve masking (or blinding) the treatment so that neither the participants nor their doctors or nurses know if they are taking an active or dummy treatment. Over the past several years, we have pioneered ways of running randomised trials involving thousands of people efficiently and cost-effectively to gain reliable information. We have developed a wide experience of using IT and centrally-held health records to streamline the running of large trials. Ongoing studies include testing a cholesterol-lowering drug added to statin therapy in people at high risk of heart problems, a new treatment for kidney disease and testing an established medication to investigate whether it can slow the worsening of eye disease in people with diabetes.
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