Decentralized Clinical Trials had a significant push during the COVID-19 pandemic, as many activities performed in hospitals had to be moved somewhere else, mainly at the patients’ homes. The advantages of this shift are so obvious that, at the end of the pandemic, many activities remain decentralized: but of course, both sponsors and Investigators need some guidance.

Therefore, the FDA has released final guidance on conducting clinical trials with decentralized elements, providing recommendations for incorporating remote activities like telehealth visits and local healthcare provider visits. The guidance applies to trials involving drugs, biological products, and devices, and emphasizes that regulatory requirements are the same for decentralized and traditional trials. It highlights the responsibilities of sponsors and investigators to ensure trial oversight, data integrity, and participant safety. This final guidance updates and finalizes the draft version issued on May 3, 2023.1

Read more here.

References

  1. Conducting clinical trials with decentralized elements; guidance for industry, investigators, and other interested parties availability. (2024, September 18). Federal Register. https://www.federalregister.gov/documents/2024/09/18/2024-21078/conducting-clinical-trials-with-decentralized-elements-guidance-for-industry-investigators-and-other

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