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Do non-inferiority trials of reduced intensity therapies show reduced effects? A descriptive analysis.

Abstract：

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. DESIGN:This metaresearch study used a cohort of non-inferiority trials published in the five highest impact general medical journals during a 5-year period. Data relating to the characteristics and results of the trials were abstracted. PRIMARY OUTCOME MEASURES:Proportions of trials with a declaration of superiority, non-inferiority and point estimates favouring the experimental therapy and mean absolute risk differences for trials with outcomes expressed as a proportion. RESULTS:Our search yielded 163 trials reporting 182 non-inferiority comparisons; 36 comparisons from 31 trials were between the same therapy at reduced and full intensity. Compared with trials not evaluating reduced intensity therapies, fewer comparisons of reduced intensity therapies demonstrated a favourable result (non-inferiority or superiority) (58.3%vs82.2%; P=0.002) and fewer demonstrated superiority (2.8%vs18.5%; P=0.019). Likewise, point estimates for reduced intensity therapies more often favoured active control than those for other trials (77.8%vs39.7%; P<0.001) as did mean absolute risk differences (+2.5% vs -0.7%; P=0.018). CONCLUSIONS:Non-inferiority trials comparing a therapy at reduced intensity to the same therapy at full intensity showed reduced effects compared with other non-inferiority trials. This suggests these trials may have a high rate of type 1 errors and biocreep, with significant implications for the design and interpretation of future non-inferiority trials.

journal_name

BMJ Open

journal_title

BMJ open

authors

Aberegg SK,Hersh AM,Samore MH

doi

10.1136/bmjopen-2017-019494

subject

Has Abstract

pub_date

2018-03-02 00:00:00

pages

e019494

issue

3

issn

2044-6055

pii

bmjopen-2017-019494

journal_volume

8

pub_type

杂志文章

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