Detection of safety signals in randomised controlled trials using groupings

Carragher, Raymond (2017) Detection of safety signals in randomised controlled trials using groupings. In: Royal Statistical Society Conference 2017, 2017-09-04 - 2017-09-07.

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    Abstract

    Many different types of adverse event are routinely recorded during clinical trials. The statistical analysis of this data may need to take into account: 1.potential multiple comparison issues; 2.low power - effect sizes of adverse events in clinical trials are generally small. The use of methods which use possible groupings of adverse events (e.g. by System Organ Class) in their statistical analyses may result in an increase in the power to detect adverse event incidence while maintaining control over the Type-I error rate.