Trial Oversight + Integrated Digital Measures
A Unified Framework for Real-Time Clinical Trial Data Monitoring and Biomarker Discovery
J&J Innovative Medicines faced challenges as they operationalized their digital health technologies (DHTs) into interventional trials for autism spectrum disorder (ASD). Their clinical trial protocol required the integration of clinical, demographic, and lab data with diverse biosensor data including electrocardiogram (ECG), electroencephalogram (EEG), eye-tracking, facial action coding, and structured clinical outcome assessments (COAs), collected across trial sites and over time. This multimodal data, generated asynchronously and in varying formats, required robust, validated methods to harmonize and analyze. The sponsor’s objective was two-fold: support the real-time monitoring and analysis of study populations during the trial, and enable the discovery of stratification biomarkers for use across future trials.
Our team delivered a data science platform that operationalized the integration, processing, and quality assurance of clinical trial data streams from all relevant biosensor and clinical sources. A key advantage of this approach was the ability to process trial data within moments of collection. Custom pipelines performed automated cleaning and normalization, with interfaces enabling efficient manual review when needed. The processed data fed both routine statistical analyses outlined in the study’s statistical analysis plan (SAP) and deeper exploratory analyses. Notably, real-time dashboards and pre-configured visualizations allowed study teams to monitor patient data as it accrued, enabling early insights and population tracking.
Beyond enabling core trial objectives, the integrated platform also served as a springboard for follow on discovery. Using structured, high-integrity datasets from the system, the J&J team identified biomarker signatures predictive of distinct symptom profiles. These stratification biomarkers demonstrated differential responses to treatment, offering actionable insights into personalized treatment pathways.
This work was integrated into J&J’s Janssen Autism Knowledge Engine (JAKE) and has been co-published with members of the JAKE team in the 2022 ANCP poster abstracts:
The success of this approach inspired OmniScience to develop its general purpose product, Vivo, to automate oversight and support better decision-making in clinical trials.
