A regulatory perspective on missing data in the aftermath of the NRC report.
Stat Med
; 35(17): 2853-64, 2016 07 30.
Article
en En
| MEDLINE
| ID: mdl-26677837
ABSTRACT
The issuance of a report in 2010 by the National Research Council (NRC) of the National Academy of Sciences entitled 'The Prevention and Treatment of Missing Data in Clinical Trials,' commissioned by the US Food and Drug Administration, had an immediate impact on the way that statisticians and clinical researchers in both industry and regulatory agencies think about the missing data problem. We believe that there is currently great potential to improve study quality and interpretability-by reducing the amount of missing data through changes in trial design and conduct and by planning and conducting analyses that better account for the missing information. Here, we describe our view on some of the recommendations in the report and suggest ways in which these recommendations can be incorporated into new or ongoing clinical trials in order to improve their chance of success. Published 2015. This article is a U.S. Government work and is in the public domain in the USA.
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Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
United States Food and Drug Administration
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Ensayos Clínicos como Asunto
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Exactitud de los Datos
Tipo de estudio:
Guideline
Límite:
Humans
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Stat Med
Año:
2016
Tipo del documento:
Article
País de afiliación:
Estados Unidos