«The U.S. Food & Drug Administration (FDA) recently issued draft guidance regarding the use of digital health technology (DHT) for the remote acquisition of clinical trial data.»

«DHT can take the form of hardware and software, and is capable of collecting a wide range of clinical, physiological, psychological, behavioral, and functional data. A single clinical investigation can use multiple DHTs to collect such data. Instead of waiting for each study subject brick-and-mortar office visit, a study subject participant can provide real time DHT data to clinical trial investigators. Continuous feedback can paint a more accurate picture of the use and functionality of a medical product in a study subjects’ daily life. Remote monitoring and data collection can help address significant issues associated with the accessibility and diversity of centralized trials, which often restrict opportunities for patients to participate in clinical trials due to issues such as travel burdens, physical or cognitive limitations, and time constraints.»

Article written by Jessica M. Boubker, Kyle Y. Faget



The National Law Review