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Most noninferiority trials were not designed to preserve active comparator treatment effects.

Abstract：

OBJECTIVES:To evaluate whether noninferiority trials are designed to adequately preserve the historical treatment effect of their active comparators. STUDY DESIGN AND SETTING:We reviewed 162 noninferiority trials published in high-impact medical journals. We assessed whether trials were designed to ensure that interventions could only be declared noninferior if they preserved at least 50% of the active comparator's historical treatment effect. RESULTS:Only 25 of 162 trials (15%) were designed so that interventions could only be declared noninferior if they preserved at least 50% of the active comparator's historical treatment effect. Most trials did not provide evidence that the active comparator was effective (n = 101), provided inadequate evidence (n = 18), or used a noninferiority margin that was too wide (n = 18). In a subset of 61 noninferiority trials which referenced a prior randomized trial or meta-analysis evaluating the active comparator, only 25 (41%) used a noninferiority margin small enough to preserve at least 50% of the active comparator's treatment effect. Overall, 14 of 162 noninferiority trials (9%) would have allowed the intervention to be declared noninferior even if it was worse than either placebo or another historical control. CONCLUSION:Most noninferiority trials published in major medical journals could allow erroneous declarations of noninferiority.

journal_name

J Clin Epidemiol

journal_title

Journal of clinical epidemiology

authors

Tsui M,Rehal S,Jairath V,Kahan BC

doi

10.1016/j.jclinepi.2019.03.003

subject

Has Abstract

pub_date

2019-06-01 00:00:00

pages

82-89

eissn

0895-4356

issn

1878-5921

pii

S0895-4356(18)30599-7

journal_volume

110

pub_type

杂志文章,评审

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