Foreign Data: Sintilimab’s Development Shows What Not To Do When Pursuing US Approval

 
• By Sue Sutter

The FDA’s concerns about conduct of ORIENT-11 trial include adequacy of informed consent, uncertainty about confidence in data generated in China, and failure of development partners Innovent and Eli Lilly to consult the US regulator about the study’s design.

Tennis racket
Innovent and Lilly seemingly committed some unforced errors in how they conducted the ORIENT trial and brought the results to the US FDA. • Source: Alamy

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