Professor Chris Butler: the importance of randomised controlled trials
Chris Butler, Professor of Primary Care at Oxford University’s Nuffield Department of Primary Care Health Sciences, highlights the importance of randomised controlled trials (RCTs), and the great work of the Clinical Trial's Unit, specifically in relation to the PRINCIPLE trial:
The randomised clinical trial is the best tool we have for finding out if treatments work. The pandemic research response has taught us yet again that we cannot rely on observational research, or the analysis of routinely collected data, when it comes to answering questions about the effectiveness of treatments.
During the H1N1 (Swine Flu) pandemic, not a single patient anywhere in the world was randomised in a clinical trial, so we still don’t know if the Tamiflu we gave out in large quantities did more good than harm. Traditionally, too, each individual medicine has required a separate trial to be designed and set up, which is very time consuming and inefficient; until now, the time to result has been measured in years, and pandemic trials have typically opened to recruitment when a pandemic is more or less over.
This time healthcare professionals did so much better. Because of the comprehensive range of expertise and unstinting commitment of the professionals working in our Primary Care Clinical Trials Unit, PCCTU, we were able to open the PRINCIPLE Trial of repurposed medicines for COVID-19 within two weeks of staring to write the protocol, and that single innovative trial has had no less than seven agents under evaluation, with nearly 11,000 participants randomised thus far. As with PRINCIPLE, our PCCTU was selected in open competition to lead on the design and implementation of the PANORAMIC Trial that focusses on evaluating early treatment with novel antiviral agents for COVID-19; opening on the 8 December 2021, it was one of the fasted recruiting, if not the fastest recruiting trial of a medicine ever, with nearly 26,000 participants already randomised. People can contribute to these ground-breaking trials often without needing to leave their sick bed at home. They are ‘democratic’ trials, in that participation does not depend on where one lives or receives health care.
The superb research scientists in the PCCTU and in our wider collaboration, are delivering these and other critically important, innovative trials to the highest international standards. We salute our multidisciplinary team that covers all the essential functions for the design and implementation of rigorous randomised trials; each one of our research team is ‘mission critical’ to generating clinical evidence that is guiding care worldwide, not only for COVID, but for trials in all our priority thematic areas.
Maximum respect to you all!