Module 5 Presentations

05/07/2024

The Organisation for Professionals in Regulatory Affairs

Ketek case -study 3014

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Ketek case - study 3014 (1)

• Published in New England Journal of Medicine, April 19, 2007 • 2000 - Ketek New Drug application submitted to FDA • 2001 -”Safety concerns“ raised by reviewers

• Federal advisory committee asked applicant to obtain additional safety data by conducting a study involving patients who were likely to receive Ketek if the drug were approved • Recruited more than 1800 physicians to conduct the study (many of them new to clinical investigation), and paid them as much as $400 per patient enrolled, • More than 24,000 subjects were enrolled. • The study was completed in 5 months and purported to show that Ketek was as safe as the other treatment.

The Organisation for Professionals in Regulatory Affairs

Ketek case -study 3014

72

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