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 Insights. If you are looking for a more detailed dive into our thoughts on the matter, please consider taking a look at our Industry Insights.
When polled, most CROs report that they expect virtual trials to be a major portion of their study portfolios now and for the foreseeable future. As of now, Digital Medicine Society (DiME) has logged 302 novel digital endpoints in their growing Library of Digital Endpoints. It seems that industry-wide comfort with new methodologies is on the rise and we are poised to see swift and widespread adoption of emerging strategies for the collection of data and conduct of decentralized clinical trials (DCT).
Without insights data has no value. Decentralized trials hold the promise of generating useful patient data from sources that were previously inaccessible. Data-lake was a buzzword circulating the eClinical industry not long ago. The concept describes a place to store all data of any kind. It finds more relevance in this push towards trial decentralization. Much of the force behind decentralized trials is the potential access to an unprecedented amount of direct patient data, data collected by sensors and ePRO and new patient populations previously excluded from clinical trials. But this increase of data carries with it the very real need for tools capable of analyzing it.
The technologies that support decentralized trials and this increasing volume of data must provide Insight. They build the capabilities necessary to determine, in this sea of information, how the outcomes of one trial relate importantly to those of another, or how one patient population can inform the selection of another. These are powerful possibilities that are only made real when the data and the tools to understand the data are brought together.
Datatrak EDC has long had rich ad-hoc reporting tools capable of accessing any data point within patient casebooks. More recently, however, we began a Business Intelligence initiative beginning with our CTMS platform. These new utilities are capable of ingesting unstructured data external to the system. This means that data coming from historic study databases, new wearables or third party eClinical systems can be structured into reports. Tools like this are essential for driving the efforts behind risk based monitoring, expanded patient recruitment and the discovery of new uses for existing therapies. These are just a few of the possibilities offered by DCTs supported by technologies like Datatrak’s clinical research platform.
This means that when you are assembling the trusted partners that make up the technological backbone of your organization, you must trust the capabilities of their analytical and reporting faculties. Simply having the reports you expect now is not enough. A robust system will give you real control over your data. It will provide you with novel and actionable insight into what that information really means, and will empower you to seek those insights on your own. Each trial we conduct may have real value for the next. To realize that value, the technologies that power decentralized trials must provide Insight.