Clinical trials in the midst of the COVID-19 pandemic

The COVID-19 pandemic has had a huge impact internationally across all sectors of industry, and clinical trials have not escaped its reach. It has affected everything from recruitment to trial monitoring, and clinical trial professionals have had to rapidly rethink established procedures in order to cope with this sudden crisis. Read on to discover insights from our Clinical Trials Manager, Katy Burdett, into how we have adapted our clinical trial operations to prevent delays in the release of our cancer screening devices.

Adapting to a new way of working

COVID-19 has presented a number of challenges as clinical trial sponsors work to keep their trials running without risking the safety of trial participants and their staff. At some sites, clinical trial recruitment has been brought to a halt, and for others, assessments that would normally take place in research facilities are now facilitated in different locations – for instance, through home visits and by delivering drugs directly to residences to lessen the risk of spreading COVID-19.

Despite implementing ‘work-arounds’, trials are becoming vastly limited in the range of assessments and procedures that can be performed – for example, it is not possible to take a blood test or a venepuncture while observing social distancing measures. Governing bodies and insurers have also implemented procedural changes, including additional risk assessments. This has naturally resulted in an enormous amount of extra paperwork.

Remote monitoring of clinical trials

Sponsors have a legal obligation to ensure participant safety and data integrity. This process is called monitoring. Traditionally, monitoring is conducted through onsite visits to the locations at which the participant procedures of the clinical trial are performed and carrying out a process called source data verification (SDV). Simply put, SDV is the comparison of medical records and procedural logs against the data recorded in the Sponsor’s study database to check for errors such as inconsistencies and procedural errors that could risk participant safety. Most of this data contains special category identifiable information which should not leave the study site. As such, moving this process onto an electronic platform is somewhat challenging.

COVID-19 has acted as a catalyst, forcing the industry to move toward a remote SDV strategy, which we ultimately believe is the future of clinical trial monitoring. Research into the cost breakdown of clinical trials shows that 15% of trial expenses arise from SDV costs alone [1]. However, remote monitoring brings with it complex regulatory challenges including data protection (GDPR) and region-specific clinical trials governance e.g. MHRA in the UK, EMA in Europe and FDA in the US. The interplay between all these factors adds another layer of complexity.

How DynamX Medical implemented remote monitoring

COVID-19 caused all of our clinical trials to be placed on hold with no clear date for reactivation of participant recruitment. This presented us with the commercial challenge of how to minimise the impact of an undefined delay to our product development. Whilst we could not control when our clinical trials would resume, we could focus on using this time to perform remote SDV on data from participants already recruited and develop methodologies to make this process more efficient in the future.

The safety of our trial participants and staff is fundamental to the company’s values and its operation. Therefore, we needed to find an affordable solution that did not pose any safety risks, whilst maintaining data privacy of this special category data. With these criteria in mind we identified three main solutions: scanning and emailing medical records with manual redactions (using marker pen or redaction tape), scanning and uploading manual redactions to a data storage server e.g. DropBox, or virtual SDV meetings using a video calling service e.g. Zoom or Microsoft Teams.

Following a consultation with our Data Protection Officer, it was determined that none of these methods provided a reliable, secure or GDPR compliant solution that did not burden either our staff or our clinical trial site staff. That is why we created our own solution in the form of an app tailored for remote SDV: Redactall. We wanted this app to be an easy-to-use mobile and web platform, and specially designed the workflows of the app to enable secure, audit ready, GDPR and GCP compliant remote redaction of confidential clinical trial data. Redactall was launched in June and is commercially available.

In a post-COVID-19 world

From recruitment to clinical trial monitoring and beyond, the industry has been forced to suddenly adapt to a “new normal” which we believe will likely remain for some time, even after the peak of the pandemic. In the midst of the disruption caused by the pandemic, innovations that can force positive changes to our industry have rapidly emerged, which we believe will ultimately minimise delays in the development of life-changing diagnostic tools and medicines. Our Redactall app is specially designed to fill this purpose by seamlessly enabling a transition to remote SDV.

To find out more about Redactall, click here.


International Clinical Trials Day and the SME perspective

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.