Sample size and power training for use in clinical trials

Webinar On Demand

Practical Methods to Overcome Sample Size Challenges

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About the webinar

In this webinar hosted by Ronan Fitzpatrick - Head of Statistics and nQuery Lead Researcher at Statsols - we will examine some of the most common practical challenges you will experience while calculating sample size for your study. These challenges will be split into two categories.

In this webinar you will learn about

1. Overcoming Sample Size Calculation Challenges (Survival Analysis Example)

We will examine practical methods to overcome common sample size calculation issues by focusing in on one of the more complex areas for sample size determination; Survival analysis. We will cover difficulties and potential issues surrounding challenges such as:

  • Drop Out: How to deal with expected dropouts or censoring. We compare the simple loss-to-follow-up method and integrating a dropout process into the sample size model?

  • Planning Uncertainty: How best to deal with the inevitable uncertainty at the planning stage? We examine how best to apply a sensitivity analysis and Bayesian approaches to explore the uncertainty in your sample size calculations.

  • Choosing the Effect Size: Various approaches and interpretations exist for how to find the effect size value. We examine those contrasting interpretations and determine the best method and also how to deal with parameterization options.

2. Overcoming Study Design Challenges
(Vaccine Efficacy Example)

The Randomised Controlled Trial (RCT) is considered the gold standard in trial design in drug development. However, there are often practical impediments which mean that adjustments or pragmatic approaches are needed for some trials and studies.

We will examine practical methods how to overcome common study design challenges and how these affect your sample size calculations. In this webinar, we will use common issues in vaccine study design to examine difficulties surrounding issues such as:

  • Case-Control Analysis: We will examine how to deal with study constraints and how to deal with analyses done during an observational study.
  • Alternative Randomization Methods: How best to address randomization in your vaccine trial design when full randomization is difficult, expensive or impractical. We examine how sample size calculations are affected with cluster or Mendelian randomization.
  • Rare Events: How does an outcome being rare affect the types of study design and statistical methods chosen in your study


Approx 1 hour

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About Our Host
Ronan Fitzpatrick

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Ronan Fitzpatrick is Head of Statistics at Statsols and the Lead Researcher for nQuery Sample Size Software. He is a guest lecturer for many institutions including the FDA.
Reducing the risk & cost of clinical trials, for innovative organizations such as:
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