Decentralized Clinical Trials Among Topics Slated For CDER Guidance In 2020
US FDA's to-do list also includes guidances on development of non-opioid analgesics and cannabis compounds, evaluation of generic therapeutic equivalence, and pediatric product development.
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Draft guidance notes that data obtained from a decentralized clinical trial may be less precise than that from a site-based trial, creating challenges in calculating a non-inferiority margin. FDA specifies what should be included in DCT data management, trial monitoring and safety monitoring plans.
Acting Commissioner says she is ‘really going to be pushing’ to have clinical trials conducted in the community. CDER’s Cavazzoni and CBER’s Marks discuss master protocols, decentralized trials, and real world evidence at DIA’s annual meeting.
US FDA drugs center’s ambitious guidance agenda lists 105 new or revised guidances, most of which carried over from the prior year; new to the list are three guidances each on real-world data and individualized antisense oligonucleotide drug products, and a document focused on demonstrating efficacy with a single adequate and well-controlled trial.