Considerations for Analyzing and Interpreting Data from Biometric Monitoring Technologies in Clinical Trials

The rise of technology in clinical research allows us to capture meaningful aspects of health in clinical study participants. In addition to questionnaires collected electronically, biometric monitoring technologies such as wearables, are now used by sponsors for drug approval—and require rigorous statistical analysis to generate acceptable clinical evidence.

We are now facing a question: What are the scientific, statistical, and regulatory frameworks for demonstrating the clinical validity of novel digital measures?

To explore this question, Adriano Fontanari, Product Marketing at Alira Health, joined Bohdana Ratitch PhD, and her team as a contributor for the article “Considerations for Analyzing and Interpreting Data from Biometric Monitoring Technologies in Clinical Trials.”

The paper “Considerations for Analyzing and Interpreting Data from Biometric Monitoring Technologies in Clinical Trials” is part of work by the Digital Medicine Society (DiMe) research team, “Standardized statistical approaches to analyze and interpret BioMeTs data,” led by Yasaman Damestani, PhD.

Publications
Published on:
September 16, 2022
Written by:
Adriano Fontanari
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