FDA has issued a new draft guidance document on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations and is accepting comments on the draft guidance until March 2022. This FDA guidance provides recommendations on the use of digital health technologies (DHTs) to acquire data from clinical investigation participants remotely.

In response to FDA’s newly issued draft guidance, join DIA for a replay webinar: Regulatory Sprint: Can We Develop an Agile Regulatory Decision Matrix for Digital Measurement? This session explores a fictional case study of a DHT used as a measurement tool in a drug clinical trial. Originally aired live at the DIA Digital Technology in Clinical Trials conference, this interactive session provides answers and insights that may help guide your interpretation of the guidance. Through a facilitated dialogue among expert panelists, regulatory considerations for endpoint selection and measurement as well as the verification and validation process as it applies to DHTs are discussed. Led by the session co-chair Megan Doyle, experts from FDA and pharmaceutical industries applied their current thinking to the case study and participated in a Q&A discussion with the audience.