By: Patrick Smith
This post is part of a blog series on what we believe the responsibilities of eClinical technologies to be in a time of increasing demand for trial decentralization. Here we examine the need for Agility. If you are looking for a more detailed dive into our thoughts on the matter, please consider taking a look at our Industry Insights.
Agility is a system’s ability to respond to change quickly. Beyond being able to accommodate changes to common practice in clinical trial conduct (as we discussed in our post on Control), that same technology must have a flexibility and ease of use necessary to do so at a moment’s notice. The pandemic saw many CRO’s and Sponsors pushed quickly to adapt more decentralized methodologies, lest they risk closing down their studies altogether. This is exactly why the ability to adapt rapidly is a necessity now more than ever for eClinical solutions. Because when the time comes to move fast, to pivot quickly to a new strategy, you need to be able to trust that your tools aren’t slowing you down.
In a 2022 study by Tufts, they note that “The mean number of protocol deviations and substantial amendments has increased across all clinical trial phases.” They found that planned and unplanned mid study changes took approximately 30 days before the study could be resumed. More importantly, those respondents who were satisfied with their EDC’s ability to manage mid study change, reported a five-day cycle time advantage to go-live again. This represents a 20 percent reduction in downtime directly related to their satisfaction with the Agility of their EDC during mid-study change. Pair all this with the fact that trial decentralization, by its very nature, increases the incidence of protocol deviations. It really underscores the point that as we navigate through this turbulent phase of change, the knowledge that your technology will empower you adapt to new challenges, is an important safety net to have in place.
Going as far back as the development of our Datatrak EDC, this has been at the core of our design philosophy: Painless mid-study change, without any downtime, ever. As our enterprise platform has grown to include CTMS, ePRO, and eConsent, we have preserved this principal. The platform will never need to be taken offline to rebuild a database or push changes out to other, less seamlessly integrated tools. The same powerful utilities that are used to build and operate trials are available to design change into your process, and that’s it. When updates are ready to go live, nothing else needs be considered.
Another important implication of Agility relates to reporting. Decentralized trials (DCTs) present us with a new informational landscape, with both an expanded access to new sources of data and an unprecedented volume of data to work with. New analytical capabilities are needed to draw insight from this information. Reports alone are not enough. The system that produces them must be agile, able to adjust easily to examine data collected across trials and ingested from novel sources outside the system itself.
Datatrak’s Business Intelligence suite is built into our CTMS and weaves into the already powerful and flexible on-demand reporting available in Datatrak’s EDC. These tools allow for a unified view of trial information. All data flowing in from any EDC, sensor technology, or other third party source can be funneled into one place. Here it can be analyzed, manipulated, and ultimately delivered as the day to day operational reporting needed in today’s trials.
We will take a look at Insights in an upcoming blog post, but for now Agility should be considered when looking for the best fit technologies to support DCTs. Control gives you the power to respond to change and seek new approaches, but Agility provides the competitive advantage of making those changes quickly, affordably and earlier than those without it.