These resources were built to help you establish a clear decision process for designing and conducting analytical validation studies, and take the uncertainty out of your regulatory interactions.
Whether you’re looking to establish a novel digital clinical measure or implement an existing measure in a new context of use, have a clear statistical analysis plan in mind or need a little bit of time to consider your strategy, are seasoned at interactions with regulators or only getting started, the resources will guide you step-by-step.
DHT developers
Accelerate your analytical validation studies and streamline your interaction with regulators
Interactive Guide to Validating Novel Digital Clinical Measures
Begin with the interactive guide, which walks you through the steps to:
- Establish your study objectives and context of use
- Select rigorous and fit-for-purpose reference measures
- Assess the effect of your intended use environment
- Consider when and how to engage regulators
Build Your Study: Novel Digital Clinical Measure Analytical Validation Planning
Next, follow the steps in the study builder to:
- Design a rigorous analytical validation study for your digital clinical measure of interest
- Use the workbook format to document your study plan
- Present your study plan and results to regulators and other stakeholders
See how others are using these resources
Eric J. Daza | Founder and Chief Editor, Stats-of-1
Chen Chen | Senior Research Fellow, Lee Kong Chian School of Medicine Singapore
Libby Floden | Biostatistician, Head of Endpoints, Evinova
Leif Simmatis | Postdoctoral Researcher, University of Toronto
DiMe Glossary
Interactive Guide to Validating Novel Digital Clinical Measures
Analytical Validation Library
Build Your Study: Novel Digital Clinical Measure Validation Planning
V3+
The Simulation Toolkit for Digital Clinical Measure Validation
