Digital: Could Clinical Trials Become More Accessible?
When COVID-19 brought the world to a standstill, TauRx had already begun its late phase clinical trial to study the efficacy of an experimental treatment for Alzheimer’s Disease. With the pandemic’s potential to negatively impact the trial, the company had a choice - stop the trial or continue its important research.
After detailed risk analysis and assessments, we found a way to continue whilst keeping our study participants safe, which was of primary importance. For us, digital held the key to unlocking this accessibility and enabling continuity.
How did we embrace digital?
Our study involves two interactive assessments for cognition and function, which make up our primary endpoints – meaning we rely on them to prove if our drug works. The data from these assessments are collated using a specialist third party vendor. Part of my job was to work closely with this service provider to find a solution that would allow us to collect this data remotely if site access was not possible.
Because of the nature of the assessments, we needed different approaches. One assessment could be carried out over the phone while the other needed a video solution. Video technology is nothing new, but it had never been used in this way during a clinical trial before. So, we had to adapt our cognitive assessments to make sure they could still be effective remotely.
Changing the assessments in this way was a risk. By changing the mode of administration, it can have unintended consequences on the data collected, potentially making subjects seem cognitively worse than they actually are. So, this was a factor we needed to consider when deciding how to proceed.
Implementing a video solution within a clinical trial is ambitious. A video solution presents a lot of challenges that a telephone solution doesn’t have. We couldn’t rely on subjects having their own device to make video calls, so we needed to make sure we had devices available to ship out to sites that could then be shipped on to subjects. Questions of data protection and privacy were also considered and resolved by ensuring video calls would be secure. These are all things that must be controlled in a clinical trial anyway, but digital added an additional layer of complexity.
Will regulators accept data collected remotely?
An unknown for the future is around how regulators will treat the data collected remotely. We’ve done everything we can to make sure we minimised the impact, but it remains an uncertainty as to how regulators will treat this data, and how their decision may affect how we apply our analyses.
Within the clinical trial space, there’s probably still some way to go before digital solutions are fully integrated. But they do have the potential to vastly increase the accessibility of clinical trials in many ways from recruitment and screening of volunteers through to data collection, which would be a huge benefit to patients, clinicians, and clinical research organisations.
Dr Suzi Morson is Data Vendor Management Officer at TauRx
TauRx is a global leader in tau-based Alzheimer’s disease research with a mission to discover, develop and commercialise innovative products for the diagnosis and treatment of neurodegenerative diseases caused by protein aggregation. They are currently working towards offering the first disease-modifying treatment targeting tau for the world’s greatest unmet medical need. Find out more at www.taurx.com
TauRx are part of the DIGITAL REDESIGN - IT'S WIN:WIN ISN'T IT? panel at the annual Life Sciences conference, find out more here.