Technology for Decentralized Trials: Providing Control and the Freedom to Innovate
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 Control. If you are looking for a more detailed dive into our thoughts on the matter please consider taking a look at our Industry Insights.
The space of clinical trials is experiencing a rush of change that hasn’t been seen in several years. The pandemic served as a catalyst that is now pushing the entire industry toward trial decentralization. Many new strategies of trial design, patient engagement, and data collection that were previously more academic discussions than real practice, are rapidly becoming the new norm. In a time of change like this, the technologies that support clinical development must provide greater levels of control. Teams running trials must have the freedom to design trial protocols in new ways, collect data from new sources and analyze that information in the context of other studies, both past and present.
Control over your trial design is critical. Re-centering trials around patients carries powerful advantages, but there is no one size fits all for clinical trials. Careful consideration must be given to which assessments and other information can be conveniently collected at the patient’s home, while others, like advanced imaging, often necessitate a site visit. Some studies utilize multiple treatment arms, one traditional and site-based, and another that is decentralized. The technology used to design and operate trials must support all the possibilities in that broad range from traditional site-centric studies to fully virtual decentralized trials.
The whole process, from training on a new system, to going live with a new study build should be quick and predictable. Personally, we aim to have new clients, after a few days of design training, to be able to create a usable first trial in under a week. This requires an intuitive system; easy to use, but also powerful enough to design studies widely varying in complexity and strategies. In this, a vendor should be capable of adjusting to the internal resources available. Fountayn can build out a study database, but control means that with a little training, the customer should have the choice to do so for themselves.
Decentralized Trials (DCTs) are driving the evolution of new sensor-based technology capable of collecting an unprecedented amount of ancillary data. Having real control over your data means that your eClinical technology provides you access, insight, and the freedom to move it. A platform must be capable of ingesting this large amount of data from new sources, but also bring to bear powerful reporting and analytic tools. DCTs may revolutionize our ability to draw actionable conclusions from historic study data in the support of new trials, but only if we can connect the dots. Dots can be difficult to connect, however when data is caught in a silo. The growing need to integrate with a new ecosystem of tools supporting DCTs and to share data between systems in the pursuit of insight, means that standardized data models, open APIs, and the ability to use them to exercise choice in who you work with must become the norm.
Because that’s what we mean by control; it is the freedom and safety to choose, to try new strategies, to change with the times. We believe in a customer-centric independence model. A reliable and powerful set of tools offers control and the confidence to innovate.