Detection of safety signals in randomised controlled trials using groupings

Raymond Carragher

Detection of safety signals in randomised controlled trials using groupings

Raymond Carragher

Mathematics And Statistics

Research output: Contribution to conference › Poster

43 Downloads (Pure)

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.

Original language	English
Number of pages	1
Publication status	Published - 5 Sept 2017
Event	Royal Statistical Society Conference 2017 - Glasgow Duration: 4 Sept 2017 → 7 Sept 2017

Conference

Conference	Royal Statistical Society Conference 2017
Abbreviated title	RSS2017
City	Glasgow
Period	4/09/17 → 7/09/17

Keywords

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

Access to Document

Carragher-RSSC2017-Detection-of-safety-signals-in-randomised-controlled-trials-using-groupingsFinal published version, 321 KB

Cite this

@conference{fa7e4cff703e4b90beec04a8b15dcbcf,

title = "Detection of safety signals in randomised controlled trials using groupings",

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. ",

keywords = "safety, clinical trials, adverse events, body system, system organ class, Bayesian hierarchy, false discovery, rate, interim analysis",

author = "Raymond Carragher",

year = "2017",

month = sep,

day = "5",

language = "English",

note = "Royal Statistical Society Conference 2017, RSS2017 ; Conference date: 04-09-2017 Through 07-09-2017",

}

TY - CONF

T1 - Detection of safety signals in randomised controlled trials using groupings

AU - Carragher, Raymond

PY - 2017/9/5

Y1 - 2017/9/5

N2 - 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.

AB - 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.

KW - safety

KW - clinical trials

KW - adverse events

KW - body system

KW - system organ class

KW - Bayesian hierarchy

KW - false discovery

KW - rate

KW - interim analysis

UR - http://www.rss.org.uk/RSS/Events/RSS_Conference/2017_Conference/RSS/Events/Conference/2017_conference.aspx

M3 - Poster

T2 - Royal Statistical Society Conference 2017

Y2 - 4 September 2017 through 7 September 2017

ER -

Detection of safety signals in randomised controlled trials using groupings

Abstract

Conference

Keywords

Access to Document

Other files and links

Fingerprint

Epsrc Doctoral Training Grant | Carragher, Raymond Bernard

Methods for detecting safety signals in clinical trials using groupings of adverse events by body-system or system organ class.

c212 : An R package for the detection of safety signals in clinical trials using body-systems (System Organ Classes)

Cite this

Detection of safety signals in randomised controlled trials using groupings

Abstract

Conference

Keywords

Access to Document

Other files and links

Fingerprint

Projects

Epsrc Doctoral Training Grant | Carragher, Raymond Bernard

Datasets

Methods for detecting safety signals in clinical trials using groupings of adverse events by body-system or system organ class.

Research output

c212 : An R package for the detection of safety signals in clinical trials using body-systems (System Organ Classes)

Cite this