FDAnews Drug Daily Bulletin

Experts Propose 33-Point Checklist for Sound Clinical Trial Designs

Feb. 1, 2013
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All clinical trial protocols should include 33 basic items, such as the dates for any protocol changes, according to a group of trial experts that has developed a checklist for sponsors.
After analyzing global clinical trial designs, the group found an overwhelming number of trials did not adequately describe primary outcomes, lacked proper treatment allocation methods, and failed to adequately detail the role of sponsors and investigators.
Clinical Trials Advisor