"JCI is collaborating with external technologists and internal teams to apply the latest tools in an effort to simplify the work of study investigators and reduce the burdens of clinical trial participation on the lives of patients."
Bert Hartog, Ph.D.
Senior Director, JCI
In this otherwise digitally connected age, clinical trial sites still too often struggle to record data through labor-intensive paper-based approaches. Study participants also expend substantial time to provide data in person, that could be readily acquired via wearables, mobile apps, smart speakers, or other technical inventions.
Janssen seeks to improve data quality within clinical trials and find ways to increase the frequency of data capture to generate more granular data sets. In exploring technological innovations, JCI also aims to improve patient participation and adherence through better engagement and improved trial access. Beyond clinical research, some of the technologies we are studying have the potential to add value in routine care as well.
Effective monitoring through digital technologies such as sensors allows the capture of objective and longitudinal data within the clinic, as well as outside of the clinic during activities of daily living. A major challenge for the industry has been ensuring there are standardized methods and services for the development and usage of these novel digital measures.
Understanding that industry challenges need an industry response, DEEP (Digital Endpoints Ecosystem and Protocols) is a JCI-led initiative that seeks to create an ecosystem of digital measures services. In discussion with other pharmaceutical and tech companies, regulators and non-profit organizations, these services are being developed with the goal to guide the processes of defining, positioning, validating and adopting novel digital measures.
The initiative aims to create a service-enabled marketplace with better practices and processes for the development and improvement of novel digital measures. This may facilitate access to digital measures for clinical development teams. In addition, this has the potential to accelerate the adoption of digital measures for clinical research and market access.
Wearable, mobile-connected technologies are expected to be a key aspect of smarter, more patient-centric clinical trials. JCI is currently investigating how smart glasses can be used to support clinical trial participation and care for patients in their homes. For example, with live video and audio streaming capabilities, the wearer can have remote interactions with their doctor while allowing their doctor to see exactly what they are seeing. In addition, the viewfinder on smart glasses can enable the wearer to receive real-time instructions for complex procedures or data capture. These are all features that have the potential to significantly reduce the burdens of clinical trial participation on the lives of patients.
JCI is also exploring the use of wearable devices to capture important clinical trial data from different populations. In a pilot program, JCI studied the utility of three types of wearable devices in 20 healthy infants and toddlers up to three years of age. These included a smart sock, a smart button, and a combination of skin patches measuring temperature, heart rate, respiration rate, and blood oxygen saturation.
Although the quality of data from these prototype devices proved more appropriate for safety monitoring than precise data collection, overall feedback from parents was positive, demonstrating that this type of monitoring may have a place in future trials involving this especially difficult-to-study population.1
At its core, conversational artificial intelligence (AI) via messaging apps, speech-based assistants and chatbots have the potential to provide human-like interactions through natural language processing, offering individuals a convenient, alternative channel to ask questions and obtain information.
JCI is currently investigating several voice-, and chat-enabled software platforms that are designed to expand patients’ ability to provide mobile feedback to clinical trial investigators. Compared to other available digital tools, voice and chat technologies are more likely to meet the deeply rooted human desire for personalization.2 These platforms may also free patients from speaking directly with practitioners, providing more flexibility for both.
A pilot study involving patients with chronic disease receiving care at a hospital yielded the surprising finding that individuals were more comfortable expressing personal feelings via this seemingly impersonal medium than in direct conversation with a healthcare professional.3 Further investigations of this application are in progress.
1 Fauvart, D., PMP (2019, September) NOPRODRSV0013
2 PRA Workshop (2019) London, England, United Kingdom.
3 World Economic Forum. 3 Ways In Which Voice Technology Will Transform Our Lives. Available at: https://www.weforum.org/agenda/2019/07/voice-technology-personalization/
4 Song, J., PHD (2019, November) Marching Towards Patient-centricity: How Technologies are Transforming Clinical Research [Conference Presentation] DIA Japan Annual (2019) Tokyo, Japan.