Today we are celebrating International Clinical Trials Day, which marks the anniversary of the first systematic clinical trial undertaken by James Lind in 1747. The study investigated the causes of scurvy on board the HMS Salisbury, and uncovered the link to vitamin C deficiency by grouping 12 men suffering from scurvy into pairs, controlling their diet and testing the effects of dietary supplements.
Each year, the 20th May is dedicated to raising the profile of clinical research and shining a light on the important work of clinical research professionals. In honour of the day, we sat down with our CEO, Dr. Liberty Foreman, to discuss clinical trial research from the perspective of a small and medium-sized enterprise (SME).
How did you begin working in clinical trials?
I first became involved in clinical trials in 2011 as a PhD student, when I was captivated by a project at UCL investigating the clinical application of infrared (IR) spectroscopy. The study gave me a reason to go into the hospital and interact directly with clinicians and patients and I was soon inspired by the life-changing implications of clinical trials. It became my mission to develop technologies that can increase efficiency in the sector and improve the experience for patients. I founded DynamX Medical with this aim in mind, and have since developed my expertise in this area by running numerous clinical trials for DynamX Medical’s diagnostic technologies.
How did you find the experience of setting up and running a clinical trial? Did you face any obstacles?
For every SME running a clinical trial for the first time, there is always the challenge of getting to grips with a new field. This involves learning completely new processes and terminology. As a spin-out company, we have also experienced first-hand the transition from running clinical trials in an academic setting to a commercial setting, which can come with a significant learning curve. From budgets and resource management through to the ethics applications, the steps required for a successful academic and commercial clinical trial can be wildly different.
Was there a turning point as you learnt more about the industry?
The turning point was meeting our current Clinical Trials Manager, Katy Burdett, and learning about her approach to clinical trial management, which is really tailored to the study in question. As we were testing diagnostics software and not an implantable medical device or novel drug, the risk to patients is low and therefore did not require 100% source data verification. This opened up the possibility of successfully running this type of clinical trial ourselves. In addition, having someone with such extensive expertise on the team helped us learn all the different elements of this complex industry much more quickly.
What did you learn from running your own clinical trials and howare you applying this knowledge in your work at DynamX?
It soon became apparent to us that there is definitely room to improve efficiency within this industry. This wasn’t just going to happen on its own, and so we began developing our own tools in the background that would make our lives easier. I remember listening to a presentation by another SME wanting to run their own clinical trial and realising that they faced the same challenges that we were presented with at the beginning. This prompted us to develop data management tools for the commercial market that enable clinical trials to be run as quickly and efficiently as possible.
In the current COVID-19 crisis, how can the latest data management tools reduce clinical trial delays?
In response to the COVID-19 pandemic, clinical trials around the globe have been postponed as monitors in charge of collecting data are prohibited from travelling to work. There is, therefore, a critical need for reliable solutions that permit remote source data verification (SDV), ensuring that you are capturing all the data that you need and that the clinical trial is running safely. In the beginning, there was a rush towards workarounds – such as creating photocopies of medical records and storing them on the cloud unredacted. This is completely against GDPR and GCP regulations.
This is why we decided to adapt our data management tools to create an app that utilises on disc encryption to enable secure redaction using only your mobile phone. Incidentally, no images are saved to the users’ device so there is also no danger of data breaches. We quickly pushed this concept into development and our Redactall app was ready for release four weeks later. This would not have been possible without some of the best experts in software engineering, commercial and privacy law and clinical trials working on the project. Nobody can predict the future, but I believe it is accepted that in a post-COVID-19 world, we will all have to adapt to a ‘new normal’. There will always be a need for site visits, but if the industry utilises remote monitoring technology, these can be reduced by 50%. This will, in turn, reduce the risk of exposure by half.
Do you have any advice for other SMEs embarking on clinical trials?
My first piece of advice would be to learn the difference between an academic and commercial clinical trial. As an SME, you’re probably going to be led by an entrepreneur who is naturally looking for the fastest and most cost-effective route forward. It is therefore really easy to overlook the scientific questions that you need to ask from the beginning. For example, in an academic setting I may want to design a study that aims to explore the difference between a cancer patient and a non-cancer patient, collecting only the minimal medical data required to determine the cancer diagnosis. But this fails to take into consideration vital information relating to lifestyle, such as smoking status, which may have a significant impact on the results of the study. This is the sort of data that can be easily overlooked when you try to minimise costs.
If you are just starting out, a great way to get to grips with the industry is to open up discussions with Contract Research Organisations (CROs), ask questions and learn from their expert knowledge. While most CROs have valuable expertise in running complex clinical trials, it is worth keeping in mind that if you have a simple device to test it may be possible to run the clinical trial yourself and reduce costs.
Finally, I would recommend utilising the knowledge of an experienced clinical trials manger, if possible. Consider advertising for a clinical trials manager with a minimum requirement of six years’ experience who will help you understand the tools that are needed for success.
Click here to learn more about our remote monitoring technology for clinical trials.