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Considerations For Using Established Versus Novel Endpoints In Decentralized Trials

 
• By Vibha Sharma

UK and US regulators explained why some established clinical endpoints are not suitable for use in decentralized trials, and discussed principles to guide the development of novel digital endpoints.

WOMAN TELEHEALTH PATIENT
Decentralized trials use technologies to collect clinical data remotely • Source: Alamy

A key consideration for sponsors planning to conduct decentralized clinical trials (DCTs) is the selection of appropriate clinical endpoints that are meaningful for regulators, health professionals and patients.

As DCTs require that some or all study-related activities are conducted at a location remote from the trial investigator, the selection of appropriate endpoints is made more complex due to...

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