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Fundamental deficiencies in the megatrial methodology

Lookup NU author(s): Dr Bruce Charlton

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Abstract

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.

Publication metadata

Author(s): Charlton BG

Publication type: Article

Publication status: Published

Journal: Current Controlled Trials in Cardiovascular Medicine

Year: 2001

Volume: 2

Issue: 1

Pages: 2-7

Date deposited: 26/02/2008

ISSN (print): 1468-6708

ISSN (electronic): 1745-6215

Publisher: BioMed Central Ltd.

URL: http://dx.doi.org/10.1186/cvm-2-1-002

DOI: 10.1186/cvm-2-1-002

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