Icon has reached a preliminary agreement with Intel to use the Intel Pharma Analytics Platform in clinical trials.
Launched in 2013, the Intel platform can continuously monitor and collect clinical data from study participants using sensors, wearables and other mobile technologies. A dedicated phone application helps patients manage medications and submit patient-reported outcomes. It also applies machine learning and other artificial intelligence methods to analyze the data, assess symptoms and quantify treatment outcomes.
Icon has been using wearables in clinical studies; in fact, the new partnership evolved from an existing working relationship in which Intel and Icon worked on clinical trials for a client and are currently running a collaborative proof-of-concept study in the respiratory area to assess feasibility of generating clinically relevant endpoints for a number of devices combined with environmental data and ePRO, Tom O’Leary, Icon's chief information officer, told FierceCRO.
“The platform can ingest unlimited data volumes from a number of device types, and provide near-real-time analysis and insight to sponsors,” said O'Leary. Because data are tracked in real time, it enables detection of patients who have difficulties with using the devices or are noncompliant. Plus, it can be integrated with the CRO’s “Direct to Patient Call Centre” for patient interaction and intervention, which can improve adherence and patient retention, explained O'Leary.
Besides, new digital endpoints could also be developed utilizing this continuous monitoring approach. O'Leary said a typical trial using this approach could potentially capture and analyze over 9,000 hours of data, which is a tremendously rich source of insight captured compared with traditional methods.
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Intel collaborated with the Michael J. Fox Foundation for Parkinson’s Research to develop the platform. In 2016, the Silicon Valley tech giant partnered with Teva on a study of pridopidine in people with Huntington’s. In that phase 2 trial, data captured through wearables generated algorithms to quantify motor symptom severity. According to Intel, its platform has also been used in population, concept validation and research studies with the Scripps Research Institute, Mount Sinai Health hospital and Radboud University in the Netherlands.
Icon has also worked with Intel in CNS, and O'Leary said there is the opportunity to deploy multisensors/devices to capture clinically relevant endpoints across all therapeutic areas.
Kaiser Associates, through confidential research conducted for Intel in 2016, predicted that by 2025, up to 70% of clinical trials will incorporate some wearable sensors. Intel said the report shows biopharma companies, CROs and medical device producers expect that using wearables will help generate high-quality data, reduce clinical trial costs, and lead to shorter trials and hence faster time to market.