FDA Guidance Offers Additional Clarity for Decentralized Clinical Trials

30 May 2023
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Key Takeaways:
  • On May 2, 2023, the Food and Drug Administration (“FDA”) released new draft guidance with recommendations to help entities conducting decentralized clinical trials (“DCTs”) to fulfill regulatory obligations. The draft guidance builds on previous draft guidances issued by FDA in 2020 to facilitate DCTs in response to the COVID-19 pandemic and in 2021 on the use of digital health technologies to collect data from clinical trial patients remotely.
  • While the draft guidance provides legal clarity for regulated entities and will continue to fuel the recent growth in DCTs, investors should consider the regulatory complexities that may arise from DCT use, such as fraud and abuse concerns, data privacy and security issues, and data licensing and ownership rights.
  • FDA is currently accepting comments and suggestions regarding the draft guidance through August 1, 2023.