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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...
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Formato: | Texto |
Lenguaje: | English |
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BioMed Central
2001
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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 |
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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 |