Noninferiority trials
<p>Abstract</p> <p>Noninferiority trials are intended to show that the effect of a new treatment is not worse than that of an active control by more than a specified margin. These trials have a number of inherent weaknesses that superiority trials do not: no internal demonstration...
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| Format: | Article |
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BMC
2000-07-01
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| Series: | Current Controlled Trials in Cardiovascular Medicine |
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| Online Access: | http://cvm.controlled-trials.com/content/1/1/019 |
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doaj-ea964c596ff54d54851e2f048ffb58c92020-11-24T21:08:15ZengBMCCurrent Controlled Trials in Cardiovascular Medicine1468-67082000-07-0111192110.1186/cvm-1-1-019Noninferiority trialsSnapinn Steven M<p>Abstract</p> <p>Noninferiority trials are intended to show that the effect of a new treatment is not worse than that of an active control by more than a specified margin. These trials have a number of inherent weaknesses that superiority trials do not: no internal demonstration of assay sensitivity, no single conservative analysis approach, lack of protection from bias by blinding, and difficulty in specifying the noninferiority margin. Noninferiority trials may sometimes be necessary when a placebo group can not be ethically included, but it should be recognized that the results of such trials are not as credible as those from a superiority trial.</p> http://cvm.controlled-trials.com/content/1/1/019assay sensitivityblindingclinical trialsequivalenceintention-to-treat |
| collection |
DOAJ |
| language |
English |
| format |
Article |
| sources |
DOAJ |
| author |
Snapinn Steven M |
| spellingShingle |
Snapinn Steven M Noninferiority trials Current Controlled Trials in Cardiovascular Medicine assay sensitivity blinding clinical trials equivalence intention-to-treat |
| author_facet |
Snapinn Steven M |
| author_sort |
Snapinn Steven M |
| title |
Noninferiority trials |
| title_short |
Noninferiority trials |
| title_full |
Noninferiority trials |
| title_fullStr |
Noninferiority trials |
| title_full_unstemmed |
Noninferiority trials |
| title_sort |
noninferiority trials |
| publisher |
BMC |
| series |
Current Controlled Trials in Cardiovascular Medicine |
| issn |
1468-6708 |
| publishDate |
2000-07-01 |
| description |
<p>Abstract</p> <p>Noninferiority trials are intended to show that the effect of a new treatment is not worse than that of an active control by more than a specified margin. These trials have a number of inherent weaknesses that superiority trials do not: no internal demonstration of assay sensitivity, no single conservative analysis approach, lack of protection from bias by blinding, and difficulty in specifying the noninferiority margin. Noninferiority trials may sometimes be necessary when a placebo group can not be ethically included, but it should be recognized that the results of such trials are not as credible as those from a superiority trial.</p> |
| topic |
assay sensitivity blinding clinical trials equivalence intention-to-treat |
| url |
http://cvm.controlled-trials.com/content/1/1/019 |
| work_keys_str_mv |
AT snapinnstevenm noninferioritytrials |
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