VeriSIM Life Partners on Digital Endpoints Adoption in Clinical Trials

In a landmark announcement, the FDA has ushered in a new era for clinical trials by qualifying the first digital endpoint under the Medical Device Development Tools (MDDT) program. This milestone marks a significant stride in the integration of digital health measures, promising to reshape how outcomes are assessed, ultimately enhancing the precision and efficiency of research endeavors.

The Digital Health Measurement Collaborative Community (DATAcc) by Digital Medicine Society (DiMe) is a collaborative community committed to advancing digital measurement and diagnostics, and they recognize the transformative potential of digital health measurement in improving overall well-being. However, the challenge lies in ensuring the widespread adoption of these innovative measures in clinical practice.

DATAcc’s’s latest initiative, "Building the Business Case for Digital Endpoints," aims to catalyze investment in digital measurement development and deployment within clinical trials. Through the development of a comprehensive value framework, benchmarking tools, ROI forecasting models, and a modular business case template, both of our organizations strive to empower innovators across the industry to embrace digital endpoints and drive their universal adoption and scalability in clinical research.

VeriSIM Life has joined this groundbreaking project as a partner to boost investment and utilization of digital endpoints by equipping decision-makers with tangible data to articulate the value of integrating these strategies into their business operations.

DATAcc, in partnership with esteemed institutions and industry leaders, including the Tufts Center for the Study of Drug Development and corporations like Johnson & Johnson, Roche, and Genentech, has already demonstrated a substantial return on investment associated with digital endpoints in clinical trials. Their findings reveal compelling evidence of cost reductions and financial benefits, underscoring the imperative to accelerate the adoption of digital measures in medical product development.

Despite progress in exploring digital endpoints, their integration into mainstream medical product development remains limited by the absence of a standardized value framework and conclusive ROI data. This highlights the critical need for initiatives like Building the Business Case for Digital Endpoints, aimed at elucidating the tangible benefits of digital endpoints and securing continued investment in their expansion.

This project aims to bridge this gap by providing organizations with the tools and resources to effectively evaluate the ROI generated by digital endpoints. By enabling informed decision-making and sustained investment in digital strategies, we aspire to unlock a myriad of benefits, including improved patient care and operational efficiency.

Through the establishment of industry benchmarks and support for building the business case for digital endpoints, this project seeks to accelerate the integration and widespread adoption of these measures in clinical trials. By optimizing financial and operational strategies, together we aim to expedite market entry and drive cost efficiency, ultimately fostering a more agile and responsive healthcare ecosystem.