Is there a danger of “biocreep” with non-inferiority trials?
نویسندگان
چکیده
Background Non-inferiority (NI) trials test a hypothesis that a new treatment is inferior to standard treatment only to a negligible degree. Bio-creep basically refers to the cyclical phenomenon where a slightly inferior treatment becomes the active control for the next generation of NI trials which over time leads to degradation of the efficacy of the investigational treatment [1,2]. We studied the effect estimates from an unselected set of all the registered non-inferiority trials conducted within a seven-year period. The aim was to determine the pre and post trial distribution of the true effect in NI trials from this data using meta-analytic methods.
منابع مشابه
Do non-inferiority trials of reduced intensity therapies show reduced effects? A descriptive analysis
OBJECTIVES To identify non-inferiority trials within a cohort where the experimental therapy is the same as the active control comparator but at a reduced intensity and determine if these non-inferiority trials of reduced intensity therapies have less favourable results than other non-inferiority trials in the cohort. Such a finding would provide suggestive evidence of biocreep in these trials....
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TO THE EDITOR—We thank Dr DiNubile for his letter and his insights. We also agree with him that in many instances vancomycin is inferior to subsequent surgical procedures in the treatment of serious methicillin-susceptible Staphylococcus aureus (MSSA) infections such as bacteremia [1]. The slippery slope of noninferiority of biocreep has been much talked about but rarely, if ever, demonstrated ...
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