Sample size and power training for use in clinical trials

Webinar

FDA Guidance on Adaptive Sample Size Re-estimation

This webinar is now available on demand

About the webinar

Given the high failure rates and the increased costs of clinical trials, researchers need innovative design strategies to best optimize financial resources and reduce the risk to patients.

Adaptive designs are emerging as a way to reduce risk and cost associated with clinical trials. The FDA recently published new draft guidance on adaptive trials and are actively encouraging sponsors to use Adaptive trials.

Adaptive trials are a type of clinical trial design that allows adaptations or modifications to aspects of the trial while it is on-going, without undermining the validity and integrity of the trial. One common adaption is a sample size re-estimation, which increases the sample size in response to interim data.

In this webinar, Ronan will demonstrate nQuery's new Adaptive module focusing on Sample Size Re-estimation, including unblinded sample size re-estimation based on interim "promising" results.

In this free webinar you will learn about

  • The FDA's view on Adaptive design
  • The pros and cons of Adaptive design
  • Sample Size Re-estimation background
  • Unblinded Sample Size Re-estimation
  • Blinded Sample Size Re-estimation

Duration

Speaker: Ronan Fitzpatrick, Head of Statistics, Statsols
Duration: 60 minutes

 

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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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