Dr Annya Smyth, Clinical Study Manager for Proteus, talks us through the first study and explains the challenges that lie ahead.
What are your responsibilities within Proteus? I am responsible for managing the design, set-up and running of the clinical studies that test both the optical Smartprobes and the evolving technology. This includes designing and developing the clinical protocols alongside the lead clinicians, obtaining the necessary approvals and working closely with the sponsor and clinical staff to ensure the study runs smoothly. I’ve also renewed my research passport to help our clinical team in the hospital to carry out the research, if it’s needed. It’s a great chance to meet the patients involved and to make sure the studies we design in our office actually work well in a clinical environment.
The process of bringing Proteus into commercial use is incredibly complex – can you walk us through the protocol?
The ultimate aim of the Proteus project is to develop technology that is accessible to clinicians worldwide, but this is a few years off. Right now we are running small, local studies to test the individual components of the technology, but we’ll eventually conduct a large regulated clinical trial to obtain valuable data about the functionality of the final imaging platform prior to potential commercialisation.
What stage of this process are Proteus at now?
The Proteus project is about halfway through its journey – we are now at the stage of our first clinical study that’s due to start in July 2016. The end goal of the project, in June 2018, is to test the fully functioning SmartProbe delivery, imaging and sensing system for the first time in humans.
Why is this clinical study important?
So far we have tested and evaluated our imaging system in animal lungs, and now we are at the stage of moving the technology into humans. We want to develop a novel approach to address the unmet needs of identifying and measuring pulmonary fibroproliferative pathway.
What’s the biggest challenge you’ve faced bringing Proteus to its first clinical study?
The biggest challenge to date, and I honestly don’t think it’s a challenge in the true sense of the word, is to ensure that those involved in working with us and approving the Versicolour device and SmartProbes for clinical use are a fully integrated part of this journey, and appreciate the low risk nature of the technology. We’ve already demonstrated that the SmartProbe and device are safe for clinical use, but the novel approach that we’re using and the state-of-the-art technology will always challenge existing perceptions which are based around more conventional research tools that are currently in use.
What challenges lie ahead?
A potential challenge that I can see in the future is the integration of the sensors to our technology. In saying that, the team have come a long way so far and are well capable of jumping any possible technical hurdles.
Interview conducted by Kate Boyd Crotty and Jessica Davis, Science Communication Master Students
https://proteus.ac.uk/wp-content/uploads/2016/12/smyth.jpg458460proteusachttps://proteus.ac.uk/wp-content/uploads/2017/05/test2.pngproteusac2016-08-01 16:11:482017-03-09 14:12:35Dr Annya Smyth Explains Proteus' First Clinical Study