Decentralized clinical trials

In decentralized  clinical trials, clinical data relating to the patient’s health status and  the delivery of treatment is routinely collected from a variety of sources: for example hospital EMR, site coordinator input, connected devices, and ePRO (patient reported outcomes). Decentralized trials have the potential to make clinical trials more accessible, and more diverse, and stimulate new product development and approval.

But – there is a dark side to DCT: Multiple systems, multiple logins, multiple data sources and loss of control.

With multiple digital health apps, connected devices and the meteoric increase in telehealth due to COVID-19, extremely large volumes of  clinical data are now being generated in decentralized  clinical trials.  Clinical data volume and velocity in DCT 5-10X that of a traditional sequential-visit-centric clinical trial.

This extreme growth poses challenges of asynchronous events, highly heterogeneous data types and privacy and security management for very large, rapidly growing datasets of clinical data often sourced from multiple vendors.

This in turn, creates a new challenge of assuring governance of clinical data created from these diverse, unmanaged assets.

We cannot realize the potential of DCT without assuring its quality and reliability. This requires automated monitoring of all the data sources; patient, investigator, and connected devices. 

 Flask Data provides single sign-on for data collection, clinical monitoring and data management.