Detection of safety signals in randomised controlled trials using groupings

Research output: Contribution to conferencePoster

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.
LanguageEnglish
Number of pages1
Publication statusPublished - 5 Sep 2017
EventRoyal Statistical Society Conference 2017 - Glasgow
Duration: 4 Sep 20177 Sep 2017

Conference

ConferenceRoyal Statistical Society Conference 2017
Abbreviated titleRSS2017
CityGlasgow
Period4/09/177/09/17

Fingerprint

Randomized Controlled Trial
Grouping
Safety
Clinical Trials
Multiple Comparisons
Effect Size
Type I Error Rate
Statistical Analysis
Incidence

Keywords

  • safety
  • clinical trials
  • adverse events
  • body system
  • system organ class
  • Bayesian hierarchy
  • false discovery
  • rate
  • interim analysis

Cite this

Carragher, R. (2017). Detection of safety signals in randomised controlled trials using groupings. Poster session presented at Royal Statistical Society Conference 2017, Glasgow, .
Carragher, Raymond. / Detection of safety signals in randomised controlled trials using groupings. Poster session presented at Royal Statistical Society Conference 2017, Glasgow, .1 p.
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author = "Raymond Carragher",
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note = "Royal Statistical Society Conference 2017, RSS2017 ; Conference date: 04-09-2017 Through 07-09-2017",

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Carragher, R 2017, 'Detection of safety signals in randomised controlled trials using groupings' Royal Statistical Society Conference 2017, Glasgow, 4/09/17 - 7/09/17, .

Detection of safety signals in randomised controlled trials using groupings. / Carragher, Raymond.

2017. Poster session presented at Royal Statistical Society Conference 2017, Glasgow, .

Research output: Contribution to conferencePoster

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KW - body system

KW - system organ class

KW - Bayesian hierarchy

KW - false discovery

KW - rate

KW - interim analysis

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M3 - Poster

ER -

Carragher R. Detection of safety signals in randomised controlled trials using groupings. 2017. Poster session presented at Royal Statistical Society Conference 2017, Glasgow, .