Health care partner David Peloquin discussed the development and future directions of clinical research regulations to protect research participants and accommodate changing practices in the University of Pennsylvania Law School’s Regulatory Review “Sunday Spotlight” column.
David provides an overview of the current framework of research regulation in the U.S. and cites decentralized clinical trials (DCTs) as one of the biggest post-pandemic changes. He notes that challenges include digital technologies used during research that require different regulatory approaches depending on whether the technology is used as a medical device or only used for purposes of data collection. He also highlights state law restrictions on the use of telemedicine technologies as a key challenge for DCTs. He explains that moving forward regulators must create clear guidelines for clinical research to minimize uncertainty.
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