Patrick McManus, MSc, Chief Development Officer, Exom Group Srl
In 2020 we saw a significant rise in the use of technology in clinical trials. The primary reason for this was the Covid-19 outbreak, forcing pharma companies and trial sites alike to look for solutions to ensure study continuity in times of a pandemic.
Where only 18% of respondents to a recent survey answered that 50% of their site visits were performed remotely in 2019, in 2020, 76% responded to this question with yes. It is expected that by 2022, generally, 50% or more of the monitoring visits will be done in a virtual model. This data shows that technology has increasingly found its way into clinical trials, a trend that will continue in 2021 and beyond.
However, not only site monitoring has fundamentally changed, but also other areas developed an entirely new approach to how clinical trials are organized and executed. In 2021, telemedicine technology, like Exom Group's Genius ROSA, will further expand the decentralized or virtual clinical trial approach.
Of course, the main reason for implementing remote monitoring technologies is the benefits they bring to a trial, such as the patient's convenience, the real-time data and insights, time and resource savings, and comfort for site staff, as well as time/resource savings for sponsors.
Telemedicine will enable underserved study populations living in rural areas to participate in clinical trials.
Resulting in more successful recruitment and thus shorter study timelines and cost savings.
The remote electronic consent, complemented with the digital signature, like Genius remote ENGAGE, increases the likelihood of recruiting patients while ensuring full compliance with all regulatory requirements, such as GDPR, HIPAA, and eIDAS.
In addition to adopting validated and secure patient-facing technologies, there are many steps involved with a move to decentralized clinical trials like the redesign of protocols and study workflows, rewriting of standard operating procedures (SOPs), as well as the unification with other platforms.
One top priority for 2021 should be the eSource, meaning the direct data capture (DDC) from electronic medical records (EMR). This scenario will result in less work for the trial sites, higher data quality, and a significantly reduced monitoring effort.
Ultimately the real-time availability of massive and detailed information and data from ongoing clinical trials enables new approaches to study management using advanced analytics and machine learning.
Advanced analytics can create value in clinical trials through improved data quality, efficient data mining, and risk-based and data-driven decision making.
Advanced analytics allows for continuous supervision of the study and empowers study managers to do an in-depth analysis and review of the data. Clinical trial data scientists can leverage centralized monitoring and CDISC standard datasets to collect data more efficiently in real-time. Instead of the analytics used for standard risk-based monitoring, they can provide better analytics. To enable quick identification of the patterns and issues, they can implement ongoing, sophisticated, and accurate monitoring reports.
In conclusion, for 2021 and beyond, innovative digital technologies will take an essential place in study management and patient monitoring, simplifying stakeholder activities, and reducing trial process cycle times.