Cargando…

Fundamental deficiencies in the megatrial methodology

The fundamental methodological deficiency of megatrials is deliberate reduction of experimental control in order to maximize recruitment and compliance of subjects. Hence, typical megatrials recruit pathologically and prognostically heterogeneous subjects, and protocols typically fail to exclude sig...

Descripción completa

Detalles Bibliográficos
Autor principal: Charlton, Bruce G
Formato: Texto
Lenguaje:English
Publicado: BioMed Central 2001
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC59645/
https://www.ncbi.nlm.nih.gov/pubmed/11806765
http://dx.doi.org/10.1186/cvm-2-1-002
_version_ 1782120092909174784
author Charlton, Bruce G
author_facet Charlton, Bruce G
author_sort Charlton, Bruce G
collection PubMed
description The fundamental methodological deficiency of megatrials is deliberate reduction of experimental control in order to maximize recruitment and compliance of subjects. Hence, typical megatrials recruit pathologically and prognostically heterogeneous subjects, and protocols typically fail to exclude significant confounders. Therefore, most megatrials do not test a scientific hypothesis, nor are they informative about individual patients. The proper function of a megatrial is precise measurement of effect size for a therapeutic intervention. Valid megatrials can be designed only when simplification can be achieved without significantly affecting experimental control. Megatrials should be conducted only at the end of a long process of therapeutic development, and must always be designed and interpreted in the context of relevant scientific and clinical information.
format Text
id pubmed-59645
institution National Center for Biotechnology Information
language English
publishDate 2001
publisher BioMed Central
record_format MEDLINE/PubMed
spelling pubmed-596452001-11-06 Fundamental deficiencies in the megatrial methodology Charlton, Bruce G Curr Control Trials Cardiovasc Med Commentary The fundamental methodological deficiency of megatrials is deliberate reduction of experimental control in order to maximize recruitment and compliance of subjects. Hence, typical megatrials recruit pathologically and prognostically heterogeneous subjects, and protocols typically fail to exclude significant confounders. Therefore, most megatrials do not test a scientific hypothesis, nor are they informative about individual patients. The proper function of a megatrial is precise measurement of effect size for a therapeutic intervention. Valid megatrials can be designed only when simplification can be achieved without significantly affecting experimental control. Megatrials should be conducted only at the end of a long process of therapeutic development, and must always be designed and interpreted in the context of relevant scientific and clinical information. BioMed Central 2001 2001-01-30 /pmc/articles/PMC59645/ /pubmed/11806765 http://dx.doi.org/10.1186/cvm-2-1-002 Text en Copyright © 2001 Charlton; licensee BioMed Central Ltd. Verbatim copying and redistribution of this article are permitted in any medium for any purpose, provided this notice is preserved along with the article's original URL.
spellingShingle Commentary
Charlton, Bruce G
Fundamental deficiencies in the megatrial methodology
title Fundamental deficiencies in the megatrial methodology
title_full Fundamental deficiencies in the megatrial methodology
title_fullStr Fundamental deficiencies in the megatrial methodology
title_full_unstemmed Fundamental deficiencies in the megatrial methodology
title_short Fundamental deficiencies in the megatrial methodology
title_sort fundamental deficiencies in the megatrial methodology
topic Commentary
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC59645/
https://www.ncbi.nlm.nih.gov/pubmed/11806765
http://dx.doi.org/10.1186/cvm-2-1-002
work_keys_str_mv AT charltonbruceg fundamentaldeficienciesinthemegatrialmethodology