Análisis interino en ensayos clínicos: una guía metodológica
Interim analysis of data accumulated in clinical trials is one aspect of the monitoring of the study progress. It is usually done to assess whether there are significant differences in efficacy between the experimental and control treatment groups, in order to decide whether to stop or no the trial...
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| Lenguaje: | Spanish / Castilian |
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Sociedad Médica de Santiago
2000
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oai:scielo:S0034-988720000008000142005-11-29Análisis interino en ensayos clínicos: una guía metodológicaMuñoz N,Sergio RBangdiwala,Shrikant I Clinical protocols Research design Statistics & numerical data Interim analysis of data accumulated in clinical trials is one aspect of the monitoring of the study progress. It is usually done to assess whether there are significant differences in efficacy between the experimental and control treatment groups, in order to decide whether to stop or no the trial prematurely. Among many reasons for early interruption of a trial is the ethical consideration that subjects should not be exposed to an unsafe, inferior or ineffective treatment. Statistical methods suited for doing interim analysis, that allow to control the probability of incorrectly rejecting the null hypothesis of no treatment differences, are often not well understood by researchers. In this article we present an intuitive, non-mathematical explanation and review of the statistical methods for doing interim analysis in clinical trials along with an illustrative example of the application of the methods on a hypothetical dataset (Rev Méd Chile 2000; 128: 935-41).info:eu-repo/semantics/openAccessSociedad Médica de SantiagoRevista médica de Chile v.128 n.8 20002000-08-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872000000800014es10.4067/S0034-98872000000800014 |
| institution |
Scielo Chile |
| collection |
Scielo Chile |
| language |
Spanish / Castilian |
| topic |
Clinical protocols Research design Statistics & numerical data |
| spellingShingle |
Clinical protocols Research design Statistics & numerical data Muñoz N,Sergio R Bangdiwala,Shrikant I Análisis interino en ensayos clínicos: una guía metodológica |
| description |
Interim analysis of data accumulated in clinical trials is one aspect of the monitoring of the study progress. It is usually done to assess whether there are significant differences in efficacy between the experimental and control treatment groups, in order to decide whether to stop or no the trial prematurely. Among many reasons for early interruption of a trial is the ethical consideration that subjects should not be exposed to an unsafe, inferior or ineffective treatment. Statistical methods suited for doing interim analysis, that allow to control the probability of incorrectly rejecting the null hypothesis of no treatment differences, are often not well understood by researchers. In this article we present an intuitive, non-mathematical explanation and review of the statistical methods for doing interim analysis in clinical trials along with an illustrative example of the application of the methods on a hypothetical dataset (Rev Méd Chile 2000; 128: 935-41). |
| author |
Muñoz N,Sergio R Bangdiwala,Shrikant I |
| author_facet |
Muñoz N,Sergio R Bangdiwala,Shrikant I |
| author_sort |
Muñoz N,Sergio R |
| title |
Análisis interino en ensayos clínicos: una guía metodológica |
| title_short |
Análisis interino en ensayos clínicos: una guía metodológica |
| title_full |
Análisis interino en ensayos clínicos: una guía metodológica |
| title_fullStr |
Análisis interino en ensayos clínicos: una guía metodológica |
| title_full_unstemmed |
Análisis interino en ensayos clínicos: una guía metodológica |
| title_sort |
análisis interino en ensayos clínicos: una guía metodológica |
| publisher |
Sociedad Médica de Santiago |
| publishDate |
2000 |
| url |
http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872000000800014 |
| work_keys_str_mv |
AT munoznsergior analisisinterinoenensayosclinicosunaguiametodologica AT bangdiwalashrikanti analisisinterinoenensayosclinicosunaguiametodologica |
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