Skip to main content

Join us for the official launch of DiMe’s Integrated Evidence Plans (IEP) resources, designed to help you overcome key challenges in evidence generation and commercial adoption of digital health technologies (DHTs)!

Register here

Join us for our launch, “Unlocking impact through investment: Building the business case for digital endpoints,” on Mar. 26 at 11 a.m. ET. Learn how new resources support you in measuring ROI and building your business case for digital endpoints.

Register here

Take the fast track to becoming a V3 and V3+ expert

Learn More

Simulation Toolkit for Digital Clinical Measure Validation

This toolkit is designed to empower you with tools that complement the Framework for Novel Digital Clinical Measures, enabling you to:

  • Investigate how a novel method for assessing agreement between measures performs in a simulated analytical validation study, even when the measures lack directly comparable units.
  • Compare the novel method with established approaches to assessing agreement in similar studies.
  • Explore how common study design factors influence the estimates gathered from these methods.
  • Experiment with a realistic data generation mechanism to simulate scenarios for your own novel digital clinical measures.

The methodology behind this toolkit is described in this manuscript.

Access the simulation toolkit on GitHub

More on statistical considerations

About this resource

Digital Measures Best Practices

Where do you want to go next on your V3+ journey?

Our resources are tailored to suit your individual journey, ensuring usability validation is seamlessly integrated into your work, no matter where you are in the process.

For technology developers and others who want to dive right in

For sponsors and clinicians who want to use off-the-shelf technology

For anyone familiar with V3 and ready to implement usability validation

Enroll in the crash course
Access the V3+ Glossary

Related resources that might interest you