FDA Expectations for using Digital Tools in Decentralized Clinical Trials

Description: The lingering pandemic health crisis has created a need to rapidly modernize digitally based clinical research. Therefore, decentralized clinical trials are in need of having a standard regulated framework to structure the use of Digital Health Technologies (DHTs) in clinical investigations.
This presentation is intended to provide best digital practices as expected by the current thinking of the FDA. To achieve adequate validation DHTs, stakeholders should ensure that the technologies utilized are sufficient to support their use, function, and interpretability. Factors in this validation include evaluating the clinical investigation population, design and operation of the intended DHT, and ability to allow the use of a study participant’s own DHT.
This presentation will highlight how DHT items should be presented in a submission. Useful directives for validation and practicality will be outlined as well as how to evaluate clinical endpoints in the context of DHTs and how to proceed if a novel clinical endpoint arises when levering these technologies.
Digital practices should adequately measure privacy-related risks. Therefore, a primer featuring key items to examine in Informed Consents that leverage DHTs will also be examined. Aspects of record protection and retention, as well as Sponsor’s and Primary Investigator’s roles and responsibilities will also be reviewed.