Emerging technologies and health data
The possibilities of capitalizing on emerging technology in healthcare are endless. The drive for improved visibility and oversight, faster trial set-up, sharing of real-time data and easier stakeholder collaboration has led to a high implementation of EDC, eTMF, RTSM and CTMS across the clinical trials arena. Although the pharmaceutical industry has been comparatively slow to adopt and embrace new technology and eClinical applications, the pace of change is accelerating. There is a real opportunity to transform clinical trials, making them more pragmatic, patient-centric and efficient by maximizing the potential to access data through electronic health records, mobile applications, and wearable devices.
Wearable technology is one of the fastest-advancing sectors of the wider technology industry, now outpacing the development of smartphones. Devices that record information such as heart rate or number of steps taken are changing the way clinical trial data is managed. Technology can now help record data more accurately and more frequently than ever before. Wearable technology is increasingly playing a role in data capture and, combined with data analytics, will enable the impact of continuous data collection to be more precisely measured.
It is estimated that there are now over 165,000 health apps available in the app stores. There are numerous and diverse uses of these apps, such as monitoring a diabetic patient’s blood glucose levels, or the ability to accurately measure and modify patient behaviour. These apps can help assess treatment effectiveness and keep patients engaged and optimized to treatment through targeted follow-up and Patient Reported Outcome (ePRO) surveys which patients can complete from home.
eSource Direct Data Capture (eSource DDC) is any technology that allows the capture of clinical study source data electronically by investigator site staff at the point of care, into an electronic form that has been specifically validated to capture clinical data. Instead of recording source data manually then later transferring this data to an online database, with e-source DDC the clinical assessment data is entered during the clinical visit data allowing validations for the data entered to occur at the same time. The data is more legible, accurate and timely with an eSource DDC system.
The drive for patient centricity and the rapidly increasing adoption of ePRO, apps, wearables, sensors and other eSource DDC solutions will facilitate virtual, digital ‘de-centralized’ trials, where subjects take part in research without having to visit a hospital or site, interacting with the study and researchers via their smart devices. PHASTAR is engaged in all of these solutions through our integrated technology platforms, enhanced by an experienced, innovative team with the skills and best practices to deliver.