A new clinical therapeutics centre has been set up by the University of Oxford to help life sciences companies identify interventions that have the greatest potential to deliver patient benefit, and so bring down the cost of early phase clinical trials.
The Oxford Centre for Clinical Therapeutics (OCCT), which has been supported by the NIHR Oxford Biomedical Research Centre (BRC), will address the high risk of failure in phase 2 proof of concept studies, which can be as high as 80 percent, and which is one reason why many drugs are so expensive.
The centre, which sits within the Nuffield Department for Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), is led by Professor Duncan Richards, the Oxford BRC’s Co-theme Lead for Musculoskeletal Medicine.
He said: “We are really interested in establishing as early in the drug development process as possible whether a new intervention – be it drugs, devices or hybrid materials – is really something that is going to make a difference for patients or not, and therefore whether it is worth proceeding.”
The centre will effectively consist of what Prof Richards calls “physical capital and intellectual capital”.
The physical infrastructure will include a clinical research facility on the Churchill Hospital site in Oxford, which will have inpatient beds that allow researchers to keep people in overnight.
The new facility will be a cross-divisional, meaning that a number of the University’s medical sciences departments will be involved, including specialists in orthopaedics, respiratory, gastroenterology, diabetes & endocrinology, neurosciences and vaccines. It will include an endoscopy/bronchoscopy room, where tissue samples can be taken, and a procedure room that will be suitable for orthopaedic and rheumatology research.
“This physical infrastructure will allow us to build our capability in this invasive kind of research work in a way that Oxford isn’t able to at the moment. This is a real opportunity to build a cross-departmental network playing to everyones strengths,” says Prof Richards, who is director of the Oxford Clinical Trials Research Unit, based within NDORMS.
As well as this physical infrastructure, he says the new centre will also aim to build decision-making potential in early-phase clinical trials, for example around the use of statistics or modelling – the “intellectual capability” he speaks of.
In this regard the Centre for Statistics in Medicine, also located in NDORMS, will be vital, thanks to the data it provides in support of clinical trials; as will the expertise in modelling and simulation at the Kennedy Institute of Rheumatology; and the know-how of the Department of Pharmacology in designing trials to test new drugs.
The new centre will primarily work with small and medium-sized enterprises in the biotech sector, initially those from the Oxford area, to identify at an early stage the potential uses of their medicine. Many of these companies lack the kind of clinical research departments that big pharmaceutical companies have, meaning the OCCT will be able to provide a valuable service that they need.
The focus will initially be on immuno-inflammation as a core theme, given that the University of Oxford has real expertise in this field, and that it is the focus of many local spin-out companies. Oncology and dementia are expected to be important areas in the medium term.
One of the main purposes of the centre is to work with these small and medium-sized enterprises to reduce the inefficiency of the early phase trials process, and so, ultimately drive down the cost of new medicines and techniques.
“Our intent is to improve the probability of success of that early-phase clinical development process, which at the moment is the least successful segment of the drug development process. Internationally, it runs at about 20% success rate, which is very poor. If you could improve that – even push it up to 30% – you’d be having a substantial impact,” Prof Richards says.
“We are in a world where what we do is incredibly expensive. We have to make it more efficient. At the moment, it’s not delivering for patients. Many of the things that are now successful are not available to patients because they are so expensive. It’s a £30m lottery ticket, rather than a £1 lottery ticket. If the car industry had the same failure rate, a Ford Escort would cost a million pounds. If you design a new car, you’re unlikely to fail completely, whereas in pharma, your most likely outcome is that you will fail completely – and you’ll probably find that out quite late and you’ll have spent a great deal of money.”
He added that the university academics would be able to work with the companies to ask the right questions, and so get a better designed trial.
“Up to now, people have effectively been rolling the dice. What we are aiming to do is pull that forward into the earlier phase of drug development and to be more rigorous about asking these questions: is this something that has real potential, or not? For a small company this may be their only asset, but their investors are certainly interested in stopping earlier if it’s not going anywhere.”
Currently many of the University’s principle investigators have individual relationships with companies.
“The concept is that the Centre for Clinical Therapeutics will provide a coordinating and organisational structure, rather than this more random approach. By engaging with them early and putting this infrastructure around it, we can identify the best people for them to work with, but also take a broader view of who they could be working with,” Prof Richards explained.
“The interest seems to be there on the biotech side, but it also seems to be there on the University side. What we’re offering them is the opportunity to work on things that are quite interesting, not coming up with another run-of-the-mill medicine that people have no interest in pursuing. It’s really about finding that commonality. The difference we can make with the Centre for Clinical Therapeutics is to do that in a more organised and coherent fashion, rather than the fragmented ‘points of light’ that we have at the moment.”
The aim of the OCCT is not to generate a profit per se. It is envisaged that any surplus the initiative does produce could be recycled into providing seed funding for principle investigators who have taken part to carry out their own home-grown research projects.