Improving Clinical Trials Through Better Data: An ROI Case Study

In the evolving world of clinical research, wearable sensor technologies are revolutionizing how we capture real-world patient outcomes. However, ensuring high-quality, usable data remains a significant challenge. As a wearable sensor CRO, VivoSense recently showcased how a strategic, holistic approach can dramatically improve digital measure outcomes in clinical trials, and our latest case study on a cystic fibrosis (CF) trial is a prime example.

The Opportunity: Capturing Meaningful Patient Experiences

A pharmaceutical sponsor aimed to integrate digital measures, from multiple wearable sensor types, into a global CF study. Carefully selected digital endpoints promised to capture meaningful aspects of patients’ daily experiences, from physical activity and sleep patterns to cough frequency. These insights would offer richer data to inform future therapeutic developments.

The Challenge: Mitigating Data Loss and Operational Complexity

VivoSense alerted the sponsor to a familiar problem: missing data. In digital trials, even small gaps in data capture can jeopardize study power, resulting in potential study failure to produce meaningful results. The sponsor needed a reliable, end-to-end solution to manage sensor-based digital health technologies (DHTs) across multiple sites while minimizing data loss and ensuring consistent, high-quality data.

The VivoSense Approach: Operational Excellence in Action

VivoSense deployed sensor-based DHTs to monitor physical activity, sleep, and cough across 200 devices at 18 sites worldwide. Our team handled the entire lifecycle — from sensor procurement,  operationalization, and participant compliance management to data cleaning, aggregation, and interpretation.

This rigorous management approach led to impactful data:

• – 99% data availability

• – 94% wear compliance

In addition, the digital measures enabled the identification of novel clinical endpoints, offering new paths for evaluating treatment effectiveness in CF and beyond.

The Impact: Cost Savings, Richer Insights, and Future Innovation

By achieving near-complete data availability, VivoSense preserved the statistical integrity of the study.  This directly affects the ROI for the sponsor by enhancing their study success and providing confidence in planning for the use of wearable DHTs in future studies.

As Dudley Tabakin, Founder & CEO of VivoSense, emphasizes:

“If missing data from sensor-based digital health technologies is not managed, the power of the study may be compromised, the results may be too variable, and the output may be misunderstood.”

This case study illustrates the tangible return on investment when clinical trials prioritize robust digital endpoint management. It also highlights how improving data availability directly enhances digital health initiatives’ scientific and financial success.

Download the full Case Study HERE