Checklist to use during the planning and execution of the validation process of novel digital endpoints for clinical trials
| Step | Question | Applicable (Y/N) | Assessment |
|---|---|---|---|
| Endpoint selection | What 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 validation | Are 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 validation | Is 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 building | What 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? | ☐ |