How to interpret clinical trials with sequential analysis that were stopped early
Sequential analysis of clinical trials allows researchers a continuous monitoring of emerging data and greater security to avoid subjecting the trial participants to a less effective therapy before the inferiority is evident, while controlling the overall error rate. Although it has been widely used...
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Medwave Estudios Limitada
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doaj-870c98b1b2c84b5c8ec108b4ee6703ec2020-11-25T03:44:46ZengMedwave Estudios LimitadaMedwave0717-63840717-63842020-06-012005e7930e793010.5867/medwave.2020.05.7930How to interpret clinical trials with sequential analysis that were stopped earlyLuis Ignacio Garegnani0Marcelo Arancibia1Eva Madrid2Juan Víctor Ariel Franco3Departamento de Investigación, Centro Cochrane Asociado, Instituto Universitario Hospital Italiano, Buenos Aires, ArgentinaCentro Interdisciplinario de Estudios de Salud (CIESAL), Escuela de Medicina, Facultad de Medicina, Universidad de Valparaíso, Valparaíso, ChileCentro Interdisciplinario de Estudios de Salud (CIESAL), Escuela de Medicina, Facultad de Medicina, Universidad de Valparaíso, Valparaíso, ChileDepartamento de Investigación, Centro Cochrane Asociado, Instituto Universitario Hospital Italiano, Buenos Aires, ArgentinaSequential analysis of clinical trials allows researchers a continuous monitoring of emerging data and greater security to avoid subjecting the trial participants to a less effective therapy before the inferiority is evident, while controlling the overall error rate. Although it has been widely used since its development, sequential analysis is not problem-free. Among them main issues to be mentioned are the balance between safety and efficacy, overestimation of the effect size of interventions and conditional bias. In this review, we develop different aspects of this methodology and the impact of including early-stopped clinical trials in systematic reviews with meta-analysis.https://www.medwave.cl/link.cgi/Medwave/Revisiones/MetodInvestReport/7930.actrandomized controlled trialbiassystematic reviewmeta-analysisepidemiology |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Luis Ignacio Garegnani Marcelo Arancibia Eva Madrid Juan Víctor Ariel Franco |
spellingShingle |
Luis Ignacio Garegnani Marcelo Arancibia Eva Madrid Juan Víctor Ariel Franco How to interpret clinical trials with sequential analysis that were stopped early Medwave randomized controlled trial bias systematic review meta-analysis epidemiology |
author_facet |
Luis Ignacio Garegnani Marcelo Arancibia Eva Madrid Juan Víctor Ariel Franco |
author_sort |
Luis Ignacio Garegnani |
title |
How to interpret clinical trials with sequential analysis that were stopped early |
title_short |
How to interpret clinical trials with sequential analysis that were stopped early |
title_full |
How to interpret clinical trials with sequential analysis that were stopped early |
title_fullStr |
How to interpret clinical trials with sequential analysis that were stopped early |
title_full_unstemmed |
How to interpret clinical trials with sequential analysis that were stopped early |
title_sort |
how to interpret clinical trials with sequential analysis that were stopped early |
publisher |
Medwave Estudios Limitada |
series |
Medwave |
issn |
0717-6384 0717-6384 |
publishDate |
2020-06-01 |
description |
Sequential analysis of clinical trials allows researchers a continuous monitoring of emerging data and greater security to avoid subjecting the trial participants to a less effective therapy before the inferiority is evident, while controlling the overall error rate. Although it has been widely used since its development, sequential analysis is not problem-free. Among them main issues to be mentioned are the balance between safety and efficacy, overestimation of the effect size of interventions and conditional bias. In this review, we develop different aspects of this methodology and the impact of including early-stopped clinical trials in systematic reviews with meta-analysis. |
topic |
randomized controlled trial bias systematic review meta-analysis epidemiology |
url |
https://www.medwave.cl/link.cgi/Medwave/Revisiones/MetodInvestReport/7930.act |
work_keys_str_mv |
AT luisignaciogaregnani howtointerpretclinicaltrialswithsequentialanalysisthatwerestoppedearly AT marceloarancibia howtointerpretclinicaltrialswithsequentialanalysisthatwerestoppedearly AT evamadrid howtointerpretclinicaltrialswithsequentialanalysisthatwerestoppedearly AT juanvictorarielfranco howtointerpretclinicaltrialswithsequentialanalysisthatwerestoppedearly |
_version_ |
1724512835374940160 |