The Ceiling Effect, the Floor Effect, and the Importance of Active and Placebo Control Arms in Randomized Controlled Trials of an Investigational Drug
Randomized controlled trials (RCTs) of a new investigational drug often include active as well as placebo control arms. The active arm, comprising an approved treatment for the indication under study, along with the placebo arm, are together required to establish assay sensitivity; if the active tre...
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| Format: | Article |
| Language: | English |
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SAGE Publishing
2021-07-01
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| Series: | Indian Journal of Psychological Medicine |
| Online Access: | https://doi.org/10.1177/02537176211021280 |
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doaj-884a4b753f3841f4988673ba6aa139532021-08-09T08:05:02ZengSAGE PublishingIndian Journal of Psychological Medicine0253-71760975-15642021-07-014310.1177/02537176211021280The Ceiling Effect, the Floor Effect, and the Importance of Active and Placebo Control Arms in Randomized Controlled Trials of an Investigational DrugChittaranjan Andrade0 Dept. of Clinical Psychopharmacology and Neurotoxicology, National Institute of Mental Health and Neurosciences, Bangalore, Karnataka, India.Randomized controlled trials (RCTs) of a new investigational drug often include active as well as placebo control arms. The active arm, comprising an approved treatment for the indication under study, along with the placebo arm, are together required to establish assay sensitivity; if the active treatment outperforms placebo, as expected, the results of the RCT can be further interpreted, but if the active treatment is no better than placebo (such as because of ceiling or floor effects), the RCT is a failed trial. The concepts involved are explained from scientific and ethical perspectives.https://doi.org/10.1177/02537176211021280 |
| collection |
DOAJ |
| language |
English |
| format |
Article |
| sources |
DOAJ |
| author |
Chittaranjan Andrade |
| spellingShingle |
Chittaranjan Andrade The Ceiling Effect, the Floor Effect, and the Importance of Active and Placebo Control Arms in Randomized Controlled Trials of an Investigational Drug Indian Journal of Psychological Medicine |
| author_facet |
Chittaranjan Andrade |
| author_sort |
Chittaranjan Andrade |
| title |
The Ceiling Effect, the Floor Effect, and the Importance of Active and Placebo Control Arms in Randomized Controlled Trials of an Investigational Drug |
| title_short |
The Ceiling Effect, the Floor Effect, and the Importance of Active and Placebo Control Arms in Randomized Controlled Trials of an Investigational Drug |
| title_full |
The Ceiling Effect, the Floor Effect, and the Importance of Active and Placebo Control Arms in Randomized Controlled Trials of an Investigational Drug |
| title_fullStr |
The Ceiling Effect, the Floor Effect, and the Importance of Active and Placebo Control Arms in Randomized Controlled Trials of an Investigational Drug |
| title_full_unstemmed |
The Ceiling Effect, the Floor Effect, and the Importance of Active and Placebo Control Arms in Randomized Controlled Trials of an Investigational Drug |
| title_sort |
ceiling effect, the floor effect, and the importance of active and placebo control arms in randomized controlled trials of an investigational drug |
| publisher |
SAGE Publishing |
| series |
Indian Journal of Psychological Medicine |
| issn |
0253-7176 0975-1564 |
| publishDate |
2021-07-01 |
| description |
Randomized controlled trials (RCTs) of a new investigational drug often include active as well as placebo control arms. The active arm, comprising an approved treatment for the indication under study, along with the placebo arm, are together required to establish assay sensitivity; if the active treatment outperforms placebo, as expected, the results of the RCT can be further interpreted, but if the active treatment is no better than placebo (such as because of ceiling or floor effects), the RCT is a failed trial. The concepts involved are explained from scientific and ethical perspectives. |
| url |
https://doi.org/10.1177/02537176211021280 |
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