Overview Of Ich New E9

Overview of ICH E9: Statistical Principles for Clinical Trials Presented by Jeff Davidson

ICH E9 cover page ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Scope and Direction

[object Object],[object Object],[object Object],[object Object],Unjustified statistics are like smiling cats - not to be trusted. Scope and Direction

[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Scope and Direction

[object Object],[object Object],[object Object],Scope and Direction

[object Object],[object Object],[object Object],Protocol and Analysis Plan

Types of Trials ,[object Object],Confirmatory Trial

Exploratory Trial ,[object Object],[object Object]

Confirmatory Trial ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Population ,[object Object],[object Object],[object Object],[object Object]

Outcome Variables ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Avoiding Bias by Design: Blinding ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Avoiding Bias by Design: Randomization ,[object Object],[object Object],[object Object]

[object Object],[object Object],Design Configuration Population A B

[object Object],[object Object],[object Object],[object Object],Design Configuration Population A B B A

[object Object],Design Configuration Population A (A1, A2) B (B1,B2) A1, B1 A1, B2 A2, B1 A2, B2

Other Study Designs ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Type of Comparison ,[object Object],[object Object],[object Object],[object Object],[object Object]

Type of Comparison ,[object Object],[object Object],[object Object],[object Object]

Type of comparison ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Sample Size ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Data Monitoring ,[object Object],[object Object]

Oversight of Trial Quality ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Monitoring Treatment Effects: Interim Analysis ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Monitoring Treatment Effects: Interim Analysis ,[object Object],Independent Statistical Team Study Team IRB Sponsor DMC

Monitoring Treatment Effects: Interim Analysis ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Data Analysis ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Analysis Sets ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Full Analysis Set ,[object Object],[object Object],[object Object]

Full Analysis Set ,[object Object],[object Object],[object Object],[object Object],[object Object]

Per Protocol Set ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Estimation and Confidence Intervals ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

Evaluation of Safety ,[object Object],[object Object],[object Object]

Example of an unacceptable adverse event

Evaluation of Safety is critical to the success of a new drug

Reporting ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

[object Object],[object Object]

Overview Of Ich New E9

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