Checklist to use during the planning and execution of the validation process of novel digital endpoints for clinical trials

StepQuestionApplicable (Y/N)Assessment
Endpoint selectionWhat aspect of the disease must be measured?
How is this aspect directly relevant to patients?
What is the optimal device, wearable, or algorithm to measure this aspect?
What are the output parameters of this device?
How can the measurement be expressed as a single outcome measure?
Is there a difference expected between patients and controls?
Technical validationAre the technical qualifications on par with researcher requirements?
Can the user experience be streamlined?
What kind of user training would optimize uptake and retention?
How does the measurement compare with the technical gold standard?
What is the intradevice and interdevice variability?
What are the sensitivity and specificity?
Does the measurement capture the aimed behavior or symptom?
Is the privacy of subjects guaranteed?
Is the data flow stable and compliant with regulatory requirements?
Clinical validationIs the device tolerable and usable for the target population?
What is the difference between patients and control subjects?
What is the difference between the several states of disease?
What influences the day-to-day variability within subjects?
Can the endpoint detect and describe clinical events or interventions?
Is the endpoint correlated to traditional endpoints?
Candidate endpoint – Application and case buildingWhat phase of clinical research is the device most suitable for?
Integration in ongoing or upcoming trials as exploratory endpoint?
Can the collected data be extrapolated to other populations?
Can anonymized data of control subjects be shared with other parties?