April 07, 2021
By Julie Gould
Anthony Costello, president of Patient Cloud at Medidata, discusses challenges facing clinical trials with regard to sensor and data usage, and explores a solution that will help lower costs and enable greater operational efficiency by making it easier for patients to share data and stay enrolled in trials.
How do clinical trials utilize sensor and digital health technology? Can you talk about the challenges facing clinical trials with regard to sensor/data usage? What impact do these challenges hold for future health care outcomes?
Sensors can help track a wide variety of key metrics including respiratory rate, sleeping patterns, blood pressure, heart rate, and other critical health functions that historically have been monitored during traditional onsite visits and check-ins. Although high-quality sensors can provide much-needed data during a clinical trial, there are major technical, logistical, and analytical challenges that come with the broad use of sensors in research. These include ingesting large quantities of data, standardizing data to a common format, developing and validating new biomarkers, and distributing sensors throughout international study sites. Many of these challenges have discouraged sponsors from widely adopting sensors in the past and our mission in developing Sensor Cloud is to solve these specific challenges.
Can you explain your recently announced Sensor Cloud platform?
Sensor Cloud is the only global, scalable, unified platform solution that simplifies and expedites sensor integration, data ingestion and analysis, and digital biomarker discovery. It enables greater insights through proprietary analytics including novel digital biomarker discovery. We develop the tools to connect to any sensor/device in a matter of weeks and ingest and normalize data from any source. We also provide the services required to deliver a sensor program through our own Patient Cloud Services organization and/or clinical research organization (CRO) partnerships that are established to deliver these types of services with Sensor Cloud.
How does Sensor Cloud help lower costs and enable greater operational efficiency by making it easier for patients to share data and stay enrolled in trials?
Sensor Cloud enables a flexible patient data capture approach that can reduce the patient burden associated with frequent site visits, while shifting qualitative data capture methods (such a patient questionnaires) to much more fluid and quantitative data from medical grade devices. Bringing these device data together with electronic data capture (EDC) data, safety data, dosing schedules and labs can begin to form a much more holistic view of what is truly happening for a patient in a real-life clinical research setting.
Can you explain how this solution standardizes data from ingestion through delivery via a common data model?
We organize ingested sensor data into a single common model data structure for all devices. The Common Model solves one of the most significant challenges with collecting sensor data -- making it ready and available for insight generation in the context of disease progression and treatment effect by standardizing the different labeling approaches to high-quality sensor data. Ultimately, this method allows our customers to “future proof” their analytics programs and validated biomarkers against any upstream decisions they may make to change sensors from study to study or across particular therapeutic areas.
How does the use of improved sensor data help reduce site and patient burden by cutting down on-site visits, time, and travel through a more flexible engagement model?
Through the use of connected health, patient data can be accessed remotely without having the patient attend a site visit. This removes a major barrier particularly for patients with serious health conditions where extensive travel can be a major impediment to enrolling or staying in trials.
What do solutions like Sensor Cloud mean for the future of care? How does this help the pharma industry improve care outcomes for their patients?
This new technology will generate intelligent insights and help improve clinical outcomes as well as lower costs and enable greater operational efficiencies. Using Sensor Cloud, researchers can access sensor data through a single Application Programming Interface (API, a software intermediary that allows two applications to talk to each other) and integrate new sensor technologies in weeks rather than months. Sensor Cloud data becomes more valuable when combined with other important clinical data housed in the Medidata Rave Clinical CloudTM. This is a unique advantage of Sensor Cloud -- accelerated biomarker development leveraging the breadth of Medidata’s data assets housed in Rave and other complementary products like eCOA to drive safety awareness and much faster efficacy signal detection for active clinical trials.
Is there anything else you would like to add to the conversation?
Collecting high-fidelity sensor data continues a trend in virtualization of clinical trials. Medidata has been trailblazing this trend with its Patient Cloud offerings including myMedidata; focusing on the patient in all that we do in clinical research is a key focus for the organization. A tight integration of Sensor Cloud with other tools can reduce patient burden through remote data capture including eConsent, eCOA, telehealth visits represent an industry-leading portfolio of technologies that streamline the experience for patients, sponsors, and our clinical research organization (CRO) partners.
About Mr Costello and Medidata
Anthony Costello is the president of Patient Cloud at Medidata, a Dassault Systemes company. He leads the strategy and development of Medidata’s Patient Cloud solutions: eCOA (clinical outcome assessment), eConsent, myMedidata patient portal, Telehealth and Virtual Visits, Sensor Cloud and Biomarker Discovery.
Medidata is a technology company that develops cloud-based solutions for clinical trials. These include everything from protocol development to post-data lock disease registries and commercial tools. The Medidata platform of capabilities allows sponsors, clinical research organizations (CROs), sites, and patients a way to work collaboratively in a clinical research setting by sharing access to critical data capture and surveillance tools such as eConsent, clinical site collaboration and management; randomization and trial supply management; patient data capture through web forms, mobile health applications like electronic patient-reported outcomes (ePRO), laboratory reports, and imaging systems; quality management; safety event capture, and monitoring and business/clinical analytics.
Medidata works with pharmaceutical, biotechnology, sensor/device, analytics, and diagnostic companies; academic and government institutions; contract research organizations, and other life sciences organizations around the world that develop and bring medical therapies and products to market.
Headquartered in New York City, Medidata has locations in China, Japan, Singapore, South Korea, the United Kingdom, and the United States.