Interim Analysis of Clinical Trial Data: Implementation and Practical Advice

Chris Pulling

Vice President

NAMSA

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Overview Types of interim analyses When are interim analyses appropriate? How are interim analysis plans implemented? When you should apply different approaches

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Types of Interim Analyses

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Early stopping for safety Generally, This is the purpose of a data

monitoring committee and data safety/monitoring committee (DMC/DSMB)

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Early stopping for efficacy Success (alpha spending functions) Futility

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Sample size re-assessments Re-estimation based on nuisance parameters (simple,

almost worthwhile . . . usually free) Re-estimation based on treatment effect (rare,

controversial)

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Administrative Analyses with no impact on study design or

management

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Investor – Milestone-based financing Not necessarily early stopping for efficacy, futility or

safety No chance to commit a type I error Type II error??

*Type I and II errors described in the complete Remote Training Series

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When are Interim Analyses Appropriate?

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It almost always makes sense to do some form of interim analysis/monitoring Most useful when there is uncertainty with alternative

hypothesis More helpful if enrollment is slow and if endpoints are acute

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