Statistical methods in recent HIV noninferiority trials: reanalysis of 11 trials.

<h4>Background</h4>In recent years the "noninferiority" trial has emerged as the new standard design for HIV drug development among antiretroviral patients often with a primary endpoint based on the difference in success rates between the two treatment groups. Different statist...

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Autor principal:	Philippe Flandre
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2011
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/04dd94e4a5b94af48314655c8c526ffa
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spelling	oai:doaj.org-article:04dd94e4a5b94af48314655c8c526ffa2021-11-18T06:46:36ZStatistical methods in recent HIV noninferiority trials: reanalysis of 11 trials.1932-620310.1371/journal.pone.0022871https://doaj.org/article/04dd94e4a5b94af48314655c8c526ffa2011-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/21915255/pdf/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4>In recent years the "noninferiority" trial has emerged as the new standard design for HIV drug development among antiretroviral patients often with a primary endpoint based on the difference in success rates between the two treatment groups. Different statistical methods have been introduced to provide confidence intervals for that difference. The main objective is to investigate whether the choice of the statistical method changes the conclusion of the trials.<h4>Methods</h4>We presented 11 trials published in 2010 using a difference in proportions as the primary endpoint. In these trials, 5 different statistical methods have been used to estimate such confidence intervals. The five methods are described and applied to data from the 11 trials. The noninferiority of the new treatment is not demonstrated if the prespecified noninferiority margin it includes in the confidence interval of the treatment difference.<h4>Results</h4>Results indicated that confidence intervals can be quite different according to the method used. In many situations, however, conclusions of the trials are not altered because point estimates of the treatment difference were too far from the prespecified noninferiority margins. Nevertheless, in few trials the use of different statistical methods led to different conclusions. In particular the use of "exact" methods can be very confusing.<h4>Conclusion</h4>Statistical methods used to estimate confidence intervals in noninferiority trials have a strong impact on the conclusion of such trials.Philippe FlandrePublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 6, Iss 9, p e22871 (2011)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Philippe Flandre Statistical methods in recent HIV noninferiority trials: reanalysis of 11 trials.
description	<h4>Background</h4>In recent years the "noninferiority" trial has emerged as the new standard design for HIV drug development among antiretroviral patients often with a primary endpoint based on the difference in success rates between the two treatment groups. Different statistical methods have been introduced to provide confidence intervals for that difference. The main objective is to investigate whether the choice of the statistical method changes the conclusion of the trials.<h4>Methods</h4>We presented 11 trials published in 2010 using a difference in proportions as the primary endpoint. In these trials, 5 different statistical methods have been used to estimate such confidence intervals. The five methods are described and applied to data from the 11 trials. The noninferiority of the new treatment is not demonstrated if the prespecified noninferiority margin it includes in the confidence interval of the treatment difference.<h4>Results</h4>Results indicated that confidence intervals can be quite different according to the method used. In many situations, however, conclusions of the trials are not altered because point estimates of the treatment difference were too far from the prespecified noninferiority margins. Nevertheless, in few trials the use of different statistical methods led to different conclusions. In particular the use of "exact" methods can be very confusing.<h4>Conclusion</h4>Statistical methods used to estimate confidence intervals in noninferiority trials have a strong impact on the conclusion of such trials.
format	article
author	Philippe Flandre
author_facet	Philippe Flandre
author_sort	Philippe Flandre
title	Statistical methods in recent HIV noninferiority trials: reanalysis of 11 trials.
title_short	Statistical methods in recent HIV noninferiority trials: reanalysis of 11 trials.
title_full	Statistical methods in recent HIV noninferiority trials: reanalysis of 11 trials.
title_fullStr	Statistical methods in recent HIV noninferiority trials: reanalysis of 11 trials.
title_full_unstemmed	Statistical methods in recent HIV noninferiority trials: reanalysis of 11 trials.
title_sort	statistical methods in recent hiv noninferiority trials: reanalysis of 11 trials.
publisher	Public Library of Science (PLoS)
publishDate	2011
url	https://doaj.org/article/04dd94e4a5b94af48314655c8c526ffa
work_keys_str_mv	AT philippeflandre statisticalmethodsinrecenthivnoninferioritytrialsreanalysisof11trials
_version_	1718424394510893056

Statistical methods in recent HIV noninferiority trials: reanalysis of 11 trials.

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