Abstract
The ability of remote research tools to collect granular, high-frequency data on symptoms and digital biomarkers is an important strength because it circumvents many limitations of traditional clinical trials and improves the ability to capture clinically relevant data. This approach allows researchers to capture more robust baselines and derive novel phenotypes for improved precision in diagnosis and accuracy in outcomes. The process for developing these tools however is complex because data need to be collected at a frequency that is meaningful but not burdensome for the participant or patient. Furthermore, traditional techniques, which rely on fixed conditions to validate assessments, may be inappropriate for validating tools that are designed to capture data under flexible conditions. This paper discusses the process for determining whether a digital assessment is suitable for remote research and offers suggestions on how to validate these novel tools.
Highlights
The emergence of SARS-CoV-2 at the turn of 2020 demonstrates how abruptly life—and research—can change
An alternative is to conduct the trial remotely, using a phone or wearable device to administer assessments in natural settings at regular intervals or in response to state changes, known as ecological momentary assessment [2,3]. This methodology reduces user burden while increasing the likelihood of the measurements capturing clinically relevant symptoms when they occur in real time, and such approaches will help to revolutionize clinical trials [3,17]
Collecting data through remote assessments may increase sample diversity, for instance, by making participation more accessible to nonstudent populations
Summary
The emergence of SARS-CoV-2 at the turn of 2020 demonstrates how abruptly life—and research—can change. An alternative is to conduct the trial remotely, using a phone or wearable device to administer assessments in natural settings at regular intervals or in response to state changes, known as ecological momentary assessment [2,3] This methodology reduces user burden while increasing the likelihood of the measurements capturing clinically relevant symptoms when they occur in real time, and such approaches will help to revolutionize clinical trials [3,17]. Assessments that are brief (or can be abbreviated), track dynamic changes, and are not limited by specific technical requirements are appropriate for high-frequency remote testing This approach captures high-resolution data that allow for the interpretation of outcomes in relation to time and location. If appropriate precautions are taken, to instruct participants to self-administer certain substances, such as caffeine, alcohol, nicotine, etc, but this would clearly not be possible in other cases (eg, controlled substances)
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
