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open-label study; single-arm study

English translation: definitions

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14:17 Mar 26, 2000
English to English translations [PRO]
Medical
English term or phrase: open-label study; single-arm study
161 patients have been treated with XX (name of the drug) at 5 mg/kg/day in two OPEN-LABEL studies and one samll, prospective, SINGLE-ARM study. No serious unexpected adverse events have been reported
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English translation:definitions
Explanation:
A type of study in which both the health providers and the patients are aware of the drug or treatment being given.
www.stjude.org/glossary

In an open label study subjects are assigned to one treatment only. In an open label study two doses of a drug are often compared.
www.clemson.edu/research/orcSite/orcIRB_DefsC.htm

Single-arm study
A group of subjects with a specified indication and managed with a specified therapy (eg involving the proposed drug are systematically observed to measure outcomes of interest. A quasi-experimental study can be generated by comparing the results of one or more single-arm studies of therapy involving the proposed drug with the results of one or more similar studies (usually by different investigators in different settings) of therapy involving its main comparator(s).
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Robert Donahue
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4 +2definitionsRobert Donahue


  

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1917 days   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +2
definitions


Explanation:
A type of study in which both the health providers and the patients are aware of the drug or treatment being given.
www.stjude.org/glossary

In an open label study subjects are assigned to one treatment only. In an open label study two doses of a drug are often compared.
www.clemson.edu/research/orcSite/orcIRB_DefsC.htm

Single-arm study
A group of subjects with a specified indication and managed with a specified therapy (eg involving the proposed drug are systematically observed to measure outcomes of interest. A quasi-experimental study can be generated by comparing the results of one or more single-arm studies of therapy involving the proposed drug with the results of one or more similar studies (usually by different investigators in different settings) of therapy involving its main comparator(s).

Robert Donahue
Native speaker of: Native in EnglishEnglish
PRO pts in pair: 538
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Peer comments on this answer (and responses from the answerer)
agree  xxxgtreyger
10 days
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agree  jennifer newsome
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