Prespecification

Scope of Trials.......................................................................................................4
Design Techniques to Avoid Bias ........................................................................8
TRIAL DESIGN CONSIDERATIONS ..........................................................11 Design Configuration .........................................................................................11 3.1.1 3.1.2 3.1.3 Parallel Group Design ..........................................................................11 Crossover Design ..................................................................................11 Factorial Designs ..................................................................................12
3.2 3.3
Multicentre Trials ..............................................................................................12 Type of Comparison............................................................................................14 3.3.1 3.3.2 3.3.3 Trials to Show Superiority ...................................................................14 Trials to Show Equivalence or Non-inferiority ...................................14 Trials to Show Dose-response Relationship ........................................16
i
Statistical Principles for Clinical Trials
3.4 3.5 3.6 IV. 4.1 4.2 4.3 4.4 4.5 4.6 V. 5.1 5.2
Group Sequential Designs ................................................................................. 16 Sample Size ........................................................................................................ 16 Data Capture and Processing............................................................................ 18 TRIAL CONDUCT CONSIDERATIONS ..................................................... 18 Trial Monitoring and Interim Analysis ............................................................ 18 Changes in Inclusion and Exclusion Criteria................................................... 19 Accrual Rates ..................................................................................................... 19 Sample Size Adjustment.................................................................................... 19 Interim Analysis and Early Stopping ............................................................... 19 Role of Independent Data Monitoring Committee (IDMC) ............................. 21 DATA ANALYSIS CONSIDERATIONS ....................................................... 21 Prespecification of the Analysis ........................................................................ 21 Analysis Sets ...................................................................................................... 22 5.2.1 5.2.2 5.2.3 Full Analysis Set .................................................................................. 22 Per Protocol Set .................................................................................... 23 Roles of the Different Analysis Sets .................................................... 24

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