El uso de metodología estadística actualizada en la investigación biomédica: el ejemplo de metodología para análisis interino en ensayos clínicos

Background: Clinical research stresses the need for evidence as a basis for setting research agendas. The extent to which current clinical research involves recent advances in biostatistics is not well known. Aim: This manuscript focuses on the use of interim analyses accumulating data in clinical t...

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Autores principales: Muñoz N,Sergio R, Bangdiwala,Shrikant I
Lenguaje:Spanish / Castilian
Publicado: Sociedad Médica de Santiago 2001
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Acceso en línea:http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872001000900002
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spelling oai:scielo:S0034-988720010009000022005-11-24El uso de metodología estadística actualizada en la investigación biomédica: el ejemplo de metodología para análisis interino en ensayos clínicosMuñoz N,Sergio RBangdiwala,Shrikant I Bibliometrics Meta-analysis Research design Statistics Background: Clinical research stresses the need for evidence as a basis for setting research agendas. The extent to which current clinical research involves recent advances in biostatistics is not well known. Aim: This manuscript focuses on the use of interim analyses accumulating data in clinical trials. Material and Methods: A PubMed search was conducted for the period 1990-2000. Keywords used included ‘interim analysis’, ‘alpha-spending function’, and ‘early termination’, after subsetting to ‘randomised controlled trials (RCT)’ that were ‘multicenter’ since these particular studies are more likely to have external monitoring boards conducting interim analyses. Studies were grouped by clinical discipline and also by journals of high or low impact index. Results: Thirteen thousand two hundred eighty two articles with both ‘RCT’ and ‘multicenter’ were found. Of these, the ‘interim analysis’ keyword yielded 879 articles, of which only 163 (19%) studies reported their methodology. The percentages varied by clinical discipline and by journal type. A 25% random sample of the articles were further reviewed to investigate the appropriateness of the interim analysis methods used. Discussion: Recent articles in the medical literature attempt to make the interim analysis methods more accessible to clinicians. However, further training of statisticians involved in clinical trials is needed as well (Rev Méd Chile 2001; 129: 983-8)info:eu-repo/semantics/openAccessSociedad Médica de SantiagoRevista médica de Chile v.129 n.9 20012001-09-01text/htmlhttp://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872001000900002es10.4067/S0034-98872001000900002
institution Scielo Chile
collection Scielo Chile
language Spanish / Castilian
topic Bibliometrics
Meta-analysis
Research design
Statistics
spellingShingle Bibliometrics
Meta-analysis
Research design
Statistics
Muñoz N,Sergio R
Bangdiwala,Shrikant I
El uso de metodología estadística actualizada en la investigación biomédica: el ejemplo de metodología para análisis interino en ensayos clínicos
description Background: Clinical research stresses the need for evidence as a basis for setting research agendas. The extent to which current clinical research involves recent advances in biostatistics is not well known. Aim: This manuscript focuses on the use of interim analyses accumulating data in clinical trials. Material and Methods: A PubMed search was conducted for the period 1990-2000. Keywords used included ‘interim analysis’, ‘alpha-spending function’, and ‘early termination’, after subsetting to ‘randomised controlled trials (RCT)’ that were ‘multicenter’ since these particular studies are more likely to have external monitoring boards conducting interim analyses. Studies were grouped by clinical discipline and also by journals of high or low impact index. Results: Thirteen thousand two hundred eighty two articles with both ‘RCT’ and ‘multicenter’ were found. Of these, the ‘interim analysis’ keyword yielded 879 articles, of which only 163 (19%) studies reported their methodology. The percentages varied by clinical discipline and by journal type. A 25% random sample of the articles were further reviewed to investigate the appropriateness of the interim analysis methods used. Discussion: Recent articles in the medical literature attempt to make the interim analysis methods more accessible to clinicians. However, further training of statisticians involved in clinical trials is needed as well (Rev Méd Chile 2001; 129: 983-8)
author Muñoz N,Sergio R
Bangdiwala,Shrikant I
author_facet Muñoz N,Sergio R
Bangdiwala,Shrikant I
author_sort Muñoz N,Sergio R
title El uso de metodología estadística actualizada en la investigación biomédica: el ejemplo de metodología para análisis interino en ensayos clínicos
title_short El uso de metodología estadística actualizada en la investigación biomédica: el ejemplo de metodología para análisis interino en ensayos clínicos
title_full El uso de metodología estadística actualizada en la investigación biomédica: el ejemplo de metodología para análisis interino en ensayos clínicos
title_fullStr El uso de metodología estadística actualizada en la investigación biomédica: el ejemplo de metodología para análisis interino en ensayos clínicos
title_full_unstemmed El uso de metodología estadística actualizada en la investigación biomédica: el ejemplo de metodología para análisis interino en ensayos clínicos
title_sort el uso de metodología estadística actualizada en la investigación biomédica: el ejemplo de metodología para análisis interino en ensayos clínicos
publisher Sociedad Médica de Santiago
publishDate 2001
url http://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872001000900002
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