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Decentralized Trials Guidance May Reflect US FDA’s Lessons Learned During COVID-19

 
• By Sue Sutter

Work on guidance that was originally expected in 2020 continues as the agency and industry learn more about the utility and spectrum of decentralized trials as a result of the novel coronavirus pandemic.

stethoscope and a smartphone with a medical app, copyspace (3d render)
Decentralized trials offer a more patient-centric approach to data collection. • Source: Shutterstock

The US Food and Drug Administration’s forthcoming guidance on decentralized clinical trials is likely to reflect some of the lessons learned from use of technology to remotely collect clinical data during the COVID-19 pandemic.

Decentralization as an operational approach in clinical research is “here to stay,” Isaac Rodriguez-Chavez, an FDA officer for clinical research methodology, regulatory compliance and medical policy development, said during...

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Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

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Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
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The Health and Human Services secretary told a Senate appropriations subcommittee that placebo-controlled trials may not be necessary to ensure vaccine safety as the FDA released a framework requiring them for COVID-19 vaccines.

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Observational, Retrospective Trials Could Retest Vaccines, HHS’ Kennedy Says

 
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Commission Taking ‘Due Account’ Of Scathing Report On EU Clinical Trial Bottlenecks

 
• By Vibha Sharma

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UK MHRA’s Clinical Trial Lead On Combined Reviews, The Notification Scheme & Increasing Diversity

 
• By Eliza Slawther

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