FDAnews Drug Daily Bulletin

Reducing Non-Core Trial Procedures Could Save Billions: Tufts Researcher

July 20, 2012
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Drugmakers are paying anywhere from $3 billion to $5 billion annually for clinical trial procedures that may not be necessary, a new study concludes. Roughly 25 percent of typical clinical trial protocols and 20 percent of trial budgets are dedicated to non-core trial procedures — those that are not directly linked to a primary or key secondary endpoint needed to demonstrate the drug’s safety or efficacy.
Clinical Trials Advisor