Janssen Autism Knowledge Engine for Clinical Trials

Autism Spectrum Disorder (ASD) is a lifelong, debilitating disorder affecting approximately 1 percent of the global population, and 1 in 68 children in the United States. Despite being one of the most common neurodevelopmental disorders with increasing prevalence in recent years, there are no approved medications to address the core symptoms of ASD, in addition to current standard of care behavioral therapies. This necessitates the study and development of targeted therapies that effectively improve clinical outcomes and quality of life for individuals with ASD (including both the core and associated symptoms of ASD).    The Janssen Autism Knowledge Engine (JAKE™) was developed to advance clinical research in autism by integrating emerging technologies into traditional clinical trial processes. JAKE™ is a new, first-of-its-kind, digital, integrated system of tools and technologies for facilitating data collection and advanced analytics in clinical trials. JAKE’s software is designed to enable advanced biomarker data collection with the ultimate goal of using the system to develop novel medicines to improve clinical outcomes for people living with ASD. The JAKE™ system consists of three components:    

• Web and mobile portals with tools for real-time tracking for caregivers and researchers, including customizable calendar-like “therapy trackers”, clinical assessments, free-text journaling that allows a parent or caregiver to record daily events related to their child's autism and exchange messages with other members of the child's care team, as well as personalized reports and charting. The combination of these tools results in real-time trial adherence monitoring capabilities for researchers.

• An integrated research biosensor platform that provides patients with sensors to quantify behavior and offer new physiologic insights, allowing for the implementation of sensitive and objective endpoints. Some biosensors utilized by JAKE are designed to be worn daily, collecting data passively on a continuous basis, while others are designed to gather feedback during a discrete battery of “challenge tasks” administered in a lab setting.

• A data pipeline driven by an analytics engine designed to support meaningful data collection in clinical trials to construct a unique picture for each child, resulting in dynamic profiles for respondents and ultimately output in clinical trials.

Three initial studies were conducted to test the components of JAKE, including two in healthy volunteers, and one in children and adults with ASD and their families. Using data from these studies, the full three-part system was finalized, and is now being tested in a large clinical validation study.    Furthermore, collaboration and clinical data-sharing can enhance research progress, improve communication between stakeholders and ultimately speed the discovery of new disease biology including potential novel treatment targets. With this philosophy in mind, Janssen is partnering with clinical research institutions and technology experts to maximize the potential for using the JAKE™ system to detect clinical outcomes in ASD.    Gahan Pandina is the Senior Director & Venture Leader at Janssen Research & Development