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US FDA Outlines Wishlist For Decentralized Clinical Trials

Companies Need Not Have An ‘All Or Nothing’ Approach

 
• By Vibha Sharma

As interest in conducting remote decentralized clinical trials grows, a senior US regulator explains what companies should consider when planning such trials.

Clinical trial
Decentralized Trials Have Drawn Pharma’s Interest • Source: Shutterstock

Remote decentralized clinical trials have piqued the pharmaceutical industry’s interest because of their ability to improve patient recruitment, retention and engagement, while allowing for continuous data capture in real-world settings.

These types of trials are relatively new. In the absence of regulatory guidance on decentralized trials, companies have been experimenting...

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