Cambridge's Experimental Medicine Initiative (EMI), supported by AstraZeneca and GSK, is training a new kind of triallist, specialists who can work out at an early stage if a treatment is likely to succeed.
More than 20,000 talented researchers, clinicians and healthcare professionals live and work in and around Cambridge. These are people with one thing in common: a determination to find new and better ways of preventing and treating disease.
But before a new treatment can be used with patients, it has to go through exhaustive clinical trials. This is a process we have become all too familiar with, as we watched the race to develop effective COVID vaccines unfold.
“The world now knows that being able to test the effectiveness of new vaccines and other medicines in a safe and timely manner is critical both to future public health emergencies and to the development of new treatments for chronic diseases,” says Ian Wilkinson, Professor of Therapeutics and Director of the Cambridge Clinical Trials Unit.
Before they were so abruptly brought to public consciousness, clinical trials had been evolving over the course of the twentieth and twenty-first centuries into a complex, highly sophisticated and heavily regulated medical specialism.
“Traditionally, clinical trials have been organised to test safety first and efficacy last,” explains Wilkinson. “It’s a cautious step-by-step approach that ensures that pharma companies can satisfy regulators that the drug is safe.”
According to Wilkinson, however, this approach, while understandable, can be problematic, as development becomes increasingly expensive and more drugs are failing at a late stage.
“When that happens,” says Wilkinson, “a company may have wasted several hundred million dollars trialling a drug that was never going to work. Leaving questions of whether a drug is effective to the final stages is now too risky and expensive.”
“We need to find out much earlier if a treatment is going to work. And we do that by looking not just at a drug’s safety in those early trials but also by studying what it’s doing to the patients. For that we need people with an unusual skillset who are in very short supply.”
A new approach
In recent years, the UK’s two pharmaceutical giants, AstraZeneca and GSK, have championed the need for more rigorous trial design to weed out likely failures earlier in the process – and have been working with the University of Cambridge to do something about it. As a collaboration, it makes perfect sense, combining the University’s research expertise with AstraZeneca and GSK’s drug discovery and development know-how.
With AstraZeneca moving its global headquarters – the Discovery Centre – to the Cambridge Biomedical Campus where GSK already has its Clinical Trials Unit, all of this expertise is now in one place, alongside not one but three, world-leading hospital trusts.
In 2016, specifically to address the shortage of suitably qualified triallists, the University set up Experimental Medicine Initiative (EMI) with funding from – and the active participation of – AstraZeneca and GSK. It has since recruited a cohort of 11 talented researchers and clinicians to its PhD programme and created six academic clinical lectureships.
The trainees all run their own clinical trials with the support of an industry, academic and clinical supervisor. The programme is designed to be a two-way street, with the trainees gaining invaluable experience while their industry partners benefit from their new approaches to experimental medicine.
Reproduced courtesy of the University of Cambridge