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A key risk indicator approach to central statistical monitoring in multicentre clinical trials: method development in the context of an ongoing large-scale randomized trial

Authors
Journal
Trials
1745-6215
Publisher
Springer (Biomed Central Ltd.)
Publication Date
Volume
12
Identifiers
DOI: 10.1186/1745-6215-12-s1-a135
Keywords
  • Poster Presentation

Abstract

A key risk indicator approach to central statistical monitoring in multicentre clinical trials: method development in the context of an ongoing large-scale randomized trial POSTER PRESENTATION Open Access A key risk indicator approach to central statistical monitoring in multicentre clinical trials: method development in the context of an ongoing large- scale randomized trial Valdés-Márquez Elsa*, Hopewell C Jemma, Landray Martin, Armitage Jane From Clinical Trials Methodology Conference 2011 Bristol, UK. 4-5 October 2011 Background Monitoring in randomized trials is recommended as part of International Conference on Harmonisation - Good Clinical Practice standards. On-site monitoring in multicentre trials is common but is costly and can be inefficient. Central statistical monitoring can be used to detect unusual data patterns, identify intentional or unintentional trial misconduct, and to prioritise on-site visits and additional training. Motivated by an ongoing international multicentre clinical trial of over 25,000 randomized participants with electronic data capture, we developed key risk indicator (KRI) methods for cen- tral statistical monitoring in multicentre trials. Method and results Statistical monitoring of KRIs such as the rate of serious adverse event reporting, compliance with study treat- ment visit duration (based on how long the electronic case report form is open for) and blood results may be informative for identifying poor site performance in ran- domized trials. We have used these KRIs to illustrate an approach to central statistical monitoring. For examining the rate of serious adverse event reporting, centres were assigned a dichotomous score depending on whether they showed extreme deviation from comparable sites (arbitrarily defined as half the observed median rate across sites). A similar approach was used to identify sites with short visit duration and these methods were also extended to examine repeated measurements of compliance with study treatm

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