Powering Phase IV Clinical Trials

Design Considerations for Post-Marketing Surveillance Trials

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Download and explore the data yourself. Data files include:

One Arm Cohort Phase IV Study - Example 1. nqt
One Arm Cohort Phase IV Study - Example 2 .nqt
Two Arm Cohort Phase IV Study - Example 2b .nqt
Case-Control Phase IV Study - Example 3 .nqt

Powering Phase IV Clinical Trials

Design Considerations for Post-Marketing Surveillance Trials

Clinical trials are primarily involved in establishing the safety and efficacy of candidate therapeutics to a high degree to allow for regulatory approval and usage in real-world patients. However, regulators still have a significant interest in ensuring the safety of therapeutics post-approval.

Therefore, post-marketing surveillance studies are a vital tool to verify the efficacy, safety and potential additional benefits of therapeutics in clinical practice - with a particular interest in finding and investigating any rare side effects.

In this free webinar, we cover the purpose of Phase IV trials, common design considerations for post-marketing surveillance trials and sample size determination for testing for rare side-effect-related outcomes.

In this free webinar you will learn about:

Phase IV Post-Marketing Surveillance Trials
Design Considerations for Phase IV Trials
Sample Size Determination for Phase IV Trials
Worked Examples for Cohort and Case-Control Designs

Powering Phase IV Clinical Trials

Clinical trials are primarily involved in establishing the safety and efficacy of candidate therapeutics to a high degree to allow for regulatory approval and usage in real-world patients.

However, regulators still have a significant interest in ensuring the safety of therapeutics post-approval. Therefore, post-marketing surveillance studies are a vital tool to verify the efficacy, safety and potential additional benefits of therapeutics in clinical practice - with a particular interest in finding and investigating any rare side effects.

However, the design of post-marketing surveillance studies is highly variable with many having inadequate design or are underpowered for their objective(s) of interest. Better consideration of design and appropriate sample size determination could lead to an improved Phase IV trial performance.

Watch this free webinar as we cover the purpose of Phase IV trials, common design considerations for post-marketing surveillance trials and sample size determination for testing for rare side-effect-related outcomes.