Simulation for Survival Group Sequential Trials

Free Webinar

Simulation for Survival Group Sequential Trials

Survival analysis is an important statistical area in oncology trials. Due to the complex nature of these trials, researchers face unique challenges. Many of these issues are exacerbated when this type of analysis is applied in the Group Sequential Trial setting. Simulation can be an invaluable tool in exploring the effects of these issues and assessing solutions.

In this webinar, Brian Fox, Research Statistician at nQuery, will explore common challenges faced when designing group sequential trials with survival endpoints. He will also review the use of simulation in this area and use it to evaluate the impact of changes to design assumptions (non-proportional hazards, interaction effects, accrual process uncertainty etc.) on these trials.

Learning objectives of this webinar:

This webinar offers practical insights into simulation techniques for survival group sequential trials, empowering researchers to design robust, efficient, and regulatory-compliant studies.

Key Areas Covered:

1. Understanding Survival Group Sequential Designs

• Recognize the advantages of interim analyses in time-to-event trials (e.g., early stopping for efficacy/futility).
• Identify challenges unique to survival endpoints (e.g., event-driven power, non-proportional hazards, unpredictable interim timing).

2. The Role of Simulation in Trial Design

• Learn how simulation validates statistical power, Type I error rates, and boundary adherence under real-world uncertainties.

• Explore scenarios where closed-form calculations fail (e.g., complex dropout patterns, changing hazard ratios).

3. Implementing Simulation-Based Solutions 

• Apply simulation to test:

  • Accrual and dropout assumptions.

  • Non-proportional hazards and alternative test statistics (e.g., Fleming-Harrington).

  • Different stopping rules (O’Brien-Fleming vs. Pocock).

• Interpret simulation outputs (e.g., expected study duration, stopping probabilities, sample size distributions).

4. Regulatory and Practical Considerations

• Understand how simulation aligns with ICH E20 and FDA/EMA guidelines for adaptive survival trials.

• Address logistical challenges (e.g., site selection, drug supply) using simulated trial trajectories.

5. Tools and Best Practices

• Discover how nQuery streamlines survival trial simulation.

• Compare simulated vs. theoretical results to optimize design robustness.

nQuery helps make your clinical trials faster, less costly and more successful. So if you need something more than just a sample size calculator, nQuery is an end-to-end platform covering Frequentist, Bayesian, and Adaptive designs with 1000+ sample size procedures. 

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