Digital Technology in Clinical Trials

Accurate collection of drug administration data, prompt detection and resolution of protocol non-compliance, and strong retention of participants are key factors in an efficient and well-run clinical trial. Manual capture and transcription of drug administration data in clinical trials can lead to errors, resource-intensive follow-up, compromised data quality, and delayed analysis, contributing to longer and more costly trials. In the ever-increasing practice of decentralized trials, it may be advantageous to measure outcomes or adverse events in correlation with time of drug intake. However, this can be challenging when the precise timing is unknown. To address these needs, we are developing connected solutions for use with injection systems, which are intended to seamlessly transmit injection data via a smartphone to the cloud. From the cloud, these injection data could integrate with the data management systems used by the contact research organization or clinical trial sponsor.

Our research revealed that the ideal solution is a data capture system that does not alter behavior or add extra burden on the user. To this end the connected injection device would act as a ‘silent reporter’, automating the capture and transmission of injection data; with minimal user involvement and minimal impact on the design and usability of the base injection device.

Details will be provided in this presentation of the first embodiment of a connected injection device and how the captured data can be integrated into a third party platform.