Active and passive remote data collection with an open-source platform
Before a new drug or vaccine is approved by the authorities, such as EMA (European Medical Agency) and FDA (United States Food and Drug Administration) a series of clinical trials needs to be conducted to establish its safety, efficacy, effectiveness, and the candidate therapy’s superiority over existing drugs and therapies. Currently, or better said, before the appearance of COVID-19, the majority of those trials was conducted on-site. Usually, contract research organizations (CROs) oversee these trials executed in hospitals and other clinical settings. It has long been a cost-intensive process for pharmaceutical companies due to long-running times and the high numbers of patients and healthy volunteers that need to be included in the trial. For participants, this process is often burdensome, and traveling to the sites for medical examination or data collection can be strenuous. Therefore, even before the COVID-19 pandemic, a movement towards decentralized or even remote trials could be observed.
Remote data collection has a number of advantages. It is less of a burden for study participants, especially patients, the costs are usually lower, more data can be collected due to continuous monitoring and the measurements provide a closer relation to real-life since participants are monitored in their home environment.
How The Hyve can help
RADAR-base is an award-winning end-to-end platform that enables remote monitoring of study participants in decentralized clinical trials through the collection, management, and storage of participant-generated data, both self-reported data from surveys and sensor data from smartphones and wearable devices. The platform supports multiple devices and can be used for a range of disease areas, as its modular plugin-based architecture allows for simple and fast extension and customization.
A set of apps allow the study leader to select and specify relevant data streams (e.g. passive data collection from sensors or active data collection through questionnaires and patient-reported outcome (PRO) forms). The platform’s distributed data streaming features allow for simultaneous processing of huge volumes of raw sensor data, while a dual data storage system and continuous data monitoring minimize the risk of data loss. RADAR-base enables both secure access to highly granular data for the development of complex prediction algorithms and to configurable aggregated data for fast and interactive visualization.
Remote data collection for clinical trials with solutions such as RADAR-base is not only important for safe drug development but also has great potential to improve research on population-level through the sheer amount of data that can be continuously collected in day-to-day life by study participants without the involvement of healthcare professionals. This movement towards participant-generated data also paves the way for personalized treatments and more efficient healthcare.
The entire RADAR-base stack is built on open-source software and is published under the Apache License Version 2.0. The platform was developed within the framework of the IMI2 RADAR-CNS project.