FDA May 2, 2023
Decentralized clinical trials and digital health technologies are gaining momentum in medical research, allowing research participants to partake in trials remotely using state-of-the-art digital health technologies. We speak to Leonard Sacks, MD, associate director for clinical methodology in CDER’s Office of Medical Policy, about the benefits as well as implementation challenges.
What are decentralized clinical trials and digital health technologies?
In a decentralized clinical trial (DCT), some or all of a clinical trial’s activities occur at locations other than a traditional clinical trial site. These alternate locations can include the participant’s home, a local health care facility, or a nearby laboratory.
DCTs often incorporate digital health technologies (DHTs), which are systems that capture health care information for the clinical trials...
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