Key Considerations for the Development and Use of Digitally Derived Measures for Clinical Investigations

Key changes

Framework for using digital health technologies (DHTs) to capture clinical outcomes; emphasis on clinical relevance and evidence requirements.

PV impact

Standardizes the use of digital tools for safety and efficacy endpoint collection in clinical trials. This facilitates continuous and real-time monitoring of adverse events and improves the reliability of safety data captured via DHTs.

Exact policy details

Digital Health Technologies and DDMs Definition

Measures derived from data collected using DHTs

Applies to: Medical devices developing clinically relevant outcome measures

This paper refers to measures derived from data collected using DHTs as digitally derived measures (DDMs). · p. 1 · High · Source

DDM Verification Requirement

A DHT used to generate a DDM should be verified and validated to be considered fit for purpose.

Applies to: Clinical investigations utilizing DDMs

In the context of clinical investigations, a DHT used to generate a DDM should be verified and validated to be considered fit for purpose. · p. 8 · High · Source

Meaningfulness of DDMs

Encourages assessment of clinical outcomes that are clinically relevant and meaningful to patients

Applies to: Developers of DDMs for clinical investigations

FDA encourages the assessment of clinical outcomes that are both clinically relevant and capture what is meaningful to patients. · p. 3 · High · Source

Justification for DDM

Start with a justification that may be updated over time for DDM selection, relevance, and validity

Applies to: Clinical investigations involving DDMs

When considering incorporating a DDM as an outcome in a clinical investigation, it can be helpful to start with a justification, which may be updated over time. · p. 3 · High · Source

Validation Steps for DDMs

Validation consists of analytical validation and clinical validation

Applies to: Developers and sponsors involved in DDM creation

Validation of a DDM consists of two major parts – analytical validation and clinical validation. · p. 8 · High · Source

Workflow rule impacts

Extracted documents

• Digitally Derived Measures for Clinical Investigations, FDA Paperhtmlhtml · high · 1 page
• Download PDFpdfpdf_text · high · 13 pages