CHDR MORE: A customized solution based on the open-source platform RADAR-base for performing clinical trials in a home-based setting.
The Dutch Centre for Human Drug Research (CHDR) is an independent institute specializing in innovative early-stage clinical drug research. To help their clients from the pharmaceutical industry gain a better understanding of how medicine use affects patients at home, they’ve started the Trial@Home service. Part of that service involves getting physical measurements from study participants at home. However, acquiring those via hand-filled reports from the participants is not the most reliable method. Instead, CHDR wanted those measurements to be made automatically using smart device sensors. This allows for movement data collection directly via the phone, while the study participants are at home. However, in 2017 there was no software available that captured this sensor data.
How we addressed it
The Hyve is a major contributor to the open-source platform RADAR-base. It was developed for remote clinical trials initiated under the IMI RADAR-CNS project. The platform was designed exactly for the type of use case described above: collecting data from study participants via wearable devices and smartphones in real-time and in a non-clinical setting.
When we were first presented with this use case, RADAR-base had just been created. For this use case, we modified the RADAR-base platform to fit the CHDR’s purpose and matured it in the process. We integrated the platform with smart devices from Withings to collect physical measurements from study participants. We created the CHDR MORE® app to monitor some aspects of smartphone usage. The app integrates with NuvoAir AirNext to collect pulmonary function data via spirometry. The participants' compliance of streaming data from the devices and the app can be monitored with a custom-developed dashboard. Finally, we integrated with the CHDR’s electronic data capture platform (EDC) Anju PromaSys to allow both systems to work together.
The RADAR-base platform provides safe and secure data collection and management for the Trial@Home service. In a follow-up project, the service is using the latest developments of RADAR-base, now more mature. For example, the initial version of the platform was installed on the CHDR’s on-premise infrastructure. The reliability and scalability were improved by migrating the platform to the secure cloud environment based on Microsoft Azure. This ensures full control and high availability of the platform and the data.
CHDR is one of the early adopters of the RADAR-base platform. The result of this use case is called CHDR MORE®, a custom-developed platform to support the Trial@home service of CHDR. This platform was validated against 21 CFR Part 11, GCP and GDPR compliance under GAMP5 framework. It has been used by CHDR in various therapeutic areas such as neurology, psychiatry, dermatology, and orthopedics. For more information about CHDR MORE® and its usage, please read CHDR’s brochure. Since 2017, The Hyve has been supporting CHDR with maintaining and adopting the platform when new studies demanded new measurement methods.