Issues in data monitoring and interim analysis of trials

Abstract

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Rapid testing for group B streptococcus during labour: a test accuracy study with evaluation of acceptability and cost-effectiveness

“…Many of the useful recommendations on the practical aspects of independent monitoring of RCTs 148,149,151 can be easily translated to the conduct of monitoring committees for test accuracy studies.…”

“…There have been numerous recommendations regarding the establishment and operation of DMCs for RCTs, most notably the UK DAMOCLES project. 151 Following a comprehensive review of the literature 151 this project provided detailed guidance on the conduct of DMCs. Other groups, including the Society for Clinical Trials, have considered monitoring arrangements for trials that typically have not employed DMCs, including early phase exploratory trials.…”

Análisis interino en ensayos clínicos: un estudio meta-epidemiológico

“…miento de la metodología de los ensayos clínicos, incluidos métodos estadísticos para calcular el efecto del azar e imparcialidad financiera, intelectual y emocional 1,2,4 .…”

Methodological and Ethical Quality Checklist Assessment in Issues of Annals of Family Medicine Clinical Trials (2010-2013)

“…We introduced AHRQ [20] ("Agency for Healthcare Research and Quality") criteria and the Jadad quality scale. We use the assessment by a DSMB (Data and Safety Monitoring Board) and "stopping rules" (Haybittle-Peto, Pocock, O'Brien-Fleming) [21]. We also evaluated sequential trials, optimized evaluated by the CREC (Clinical Research Ethics Committee) or futility analysis.…”