Considerations for development of an evidence dossier to support the use of mobile sensor technology for clinical outcome assessments in clinical trials

Contemp Clin Trials. 2020 Apr;91:105962. doi: 10.1016/j.cct.2020.105962. Epub 2020 Feb 20.


Background: Mobile sensors offer enormous potential for the collection of informative clinical endpoints in clinical trials to support regulatory decision making and product labelling. There are currently no specific guidelines on the information needed to enable regulators to review and accept proposed endpoints derived from mobile sensors for use in drug development trials.

Objective: The purpose of this working group report is to recommend the structure and content of an evidence dossier intended to support whether a clinical endpoint derived from mobile sensor data is fit-for-purpose for use in regulatory submissions for drug approvals.

Evidence dossier: The structure and content of a dossier to provide evidence supporting the use of a sensor-derived clinical endpoint is described. Sections include clinical endpoint definition and positioning, the concept of interest, the context of use, clinical validation and interpretation, study implementation, and analytical validity with sensor performance verification in support of the selected sensor.

Conclusions: In the absence of definitive regulatory guidance, this report provides a considered approach to compiling a comprehensive body of evidence to justify acceptance of mobile sensors for support of new drug applications.

Keywords: Analytical validation; Clinical endpoints; Clinical outcome assessments; Clinical validation; Evidence dossier; Medical product labelling; Mobile sensors; New drug applications; Novel endpoints; Wearables.

Publication types

  • Research Support, U.S. Gov't, P.H.S.
  • Review

MeSH terms

  • Clinical Trials as Topic / methods*
  • Clinical Trials as Topic / standards
  • Drug Approval
  • Endpoint Determination / methods*
  • Endpoint Determination / standards
  • Humans
  • Outcome Assessment, Health Care
  • Parkinson Disease / physiopathology
  • Practice Guidelines as Topic
  • Pulmonary Disease, Chronic Obstructive / physiopathology
  • Remote Sensing Technology / methods*
  • Remote Sensing Technology / standards
  • Reproducibility of Results
  • Sarcopenia / physiopathology
  • Wearable Electronic Devices / standards*