By Ebony Dashiell-Aje, Clinical Outcome Assessments Staff, Office of New Drugs, CDER, FDA; Sarrit Kovacs, Clinical Outcome Assessments Staff, Office of New Drugs, CDER, FDA; and Leonard Sacks, Office of Medical Policy, CDER, FDA
At FDA, there is a focus on evaluating and considering valuable novel approaches and tools that can support our regulatory decision-making. The dramatic growth and incorporation of digital technologies into daily life has afforded new opportunities to use these tools to understand patients’ functioning and how it is affected by different diseases and treatments.
Former FDA Commissioner Scott Gottlieb has made statements regarding advances in the field of digital health innovation, including launching the Agency’s Digital Health Innovation Action Plan. Likewise, the US President’s budget includes a proposal to create a Center of Excellence for Digital Health. In the current landscape, the Agency is receptive to innovative, technology-derived, study endpoints in various therapeutic areas.
Why Digital Health Technology Tools (DHTTs)?
Digital health technology tools (DHTTs) can help capture patient experiences in real world settings. DHTTs can include, but are not limited to, “wearables” (e.g., accelerometers), implantable or ingestible sensors (e.g., blood glucose monitors), and stationary sensors (e.g., home-based motion sensors to detect gait patterns and capture falls) that are designed to generate data not observable in traditional clinic settings. (For the purpose of this article, the term DHTT refers to an electronic technology tool, its score(s), and the interpretation of its scores that are intended for use in clinical investigations.) DHTTs can passively capture data (e.g., through accelerometers, cardiac rhythm monitors) or capture data through patient responses (e.g., an electronic patient-reported outcome [ePRO]).
In addition to providing richer and more comprehensive information on how patients are functioning and feeling, DHTTs can help minimize barriers to obtaining patient experience data during clinical investigations in many ways. For instance, DHTTs can be operated and accessed remotely, reducing both clinical site costs (e.g., decreasing the number of clinical site visits) and patient costs (e.g., travel costs, if the study requires fewer visits). Remote data collection using DHTTs has the potential to help streamline study and data monitoring procedures; help maximize recruitment efforts among hard to reach, geographically dispersed, or rare patient populations; or generally increase the chances of patient enrollment and retention in a study through decreased burden of study participation.