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open-label study; single-arm study

English translation: definitions

14:17 Mar 26, 2000
English language (monolingual) [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
gra
Selected answer: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 (X)
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4 +2definitions
Robert Donahue (X)


  

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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 (X)
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  gtreyger (X)
10 days
  -> Thank you!
agree  jennifer newsome (X)
10 days
  -> Thank you!
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