Digital Measures

Active and passive remote data collection with an open-source platform

The problem

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.

RADAR-base RADAR-base

RADAR-base is a modular solution for active and passive data collection, real-time streaming, harmonized data schemas, distributed storage and data exploration capabilities.

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What people say about The Hyve

“From our collaboration with The Hyve, the open-source RADAR-base platform has been utilised in our Trial@Home solution at CHDR. Trial@Home is a platform that enables us to collect data outside the clinical setting in early stage clinical trials for drug development. This allows us to monitor pharmacodynamics in a real‑world setting and provides added value to our customers.”

Vasileios Exadaktylos, Product Manager Trials@Home at Centre for Human Drug Research (CHDR)

"We use the RADAR-base platform in combination with various wearables as an instrument for continuous monitoring of subjects in early-phase drug trials. It enables us to reliably monitor pharmacodynamics in an at-home setting, which minimizes the burden for participants.”

Ghobad Maleki, Clinical Scientist at Centre for Human Drug Research (CHDR)

"The workshops provided by The Hyve were very helpful to understand and perform all the processes needed to transform our cohort data into the common data model (OMOP) and use the cutting-edge OHDSI tools for analyzing observational studies. We are glad to have been introduced to the OHDSI real-world data platform and networks by the experts of The Hyve."

Alexis Sentís Fuster, Epidemiologist at Centre for Epidemiological Studies of Sexually Transmitted Disease and AIDS in Catalonia (CEEISCAT)

"The Hyve is one of Europe’s leading technology IT services providers who have established an international reputation within the biomedical informatics domain, from open standards such as OHDSI to working with FAIR principles. With their passionate leadership, they have been involved in numerous projects including the European Health Data & Evidence Network (EHDEN). I have no doubt that all of these projects have benefited greatly from their thinking, insights and hands-on expertise."

Nigel Hughes, Industry Lead at IMI EHDEN Project

“We are excited to be building an open-source community around cBioPortal, and The Hyve has become an integral part of our efforts. The Hyve brings unique expertise in building open-source bioinformatics platforms, and in building bridges between academic centers and industry. We look forward to continued work together.”

Ethan Cerami, Director, Knowledge Systems Group, Department of Biostatistics and Computational Biology at Dana-Farber Cancer Institute

Let's start collaborating

  • Are you a researcher in pharma or academia or a CRO setting-up a new observational study or decentralized trial to identify digital biomarkers?
  • Are you a data scientist who wants to explore streams of patient data and develop prediction algorithms?
  • Are you an IT expert looking for a modular solution that can be integrated with devices or sensors for remote data collection?

Get in touch to find out if RADAR-base is the platform for you.

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