CLINICAL RESEARCH CASE STUDY

This document discusses issues with a clinical trial for the drug Ketek submitted to multiple IRBs. It summarizes that the GAO submitted the Ketek protocol to 3 different IRBs, two of which rejected it but one approved it. However, Ketek was withdrawn from the market in 2007 due to serious adverse events including deaths and infections. The FDA later inspected the study and issued a warning letter to the approving IRB, questioning the trial. Lessons for IRB members are to prioritize patient safety, scrutinize sponsor and protocol details, and maintain documents for at least two years.