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 . 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.