Lexology September 14, 2023
On May 2, 2023, in a move intended to accelerate the adoption of digital health technologies, the U.S. Food and Drug Administration (“FDA”) released draft guidance regarding the conduct of decentralized clinical trials (“DCTs”) for drugs, biological products and devices. This draft guidance expands on previous FDA recommendations released in the midst of the COVID-19 pandemic.
Background
A DCT is a clinical trial in which some or all trial-related activities occur at locations other than traditional trial sites. DCTs may be implemented as fully decentralized, in which all clinical activities are remote, or as a hybrid model, in which only some of the clinical activities are remote. Non-traditional sites may include locations such as participants’ homes or local health care...
Today's Sponsors
Today's Sponsor