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Printable Handouts
Navigable Slide Index
- Introduction
- Outline of presentation
- You feel lost
- Clinical trials
- Jargon
- Equivalence trials
- Motivation behind equivalence (1)
- Motivation behind equivalence (2)
- Active control trials
- Non-inferiority trials (one-sided equivalence)
- Choice of trial design
- Choice of active control [ICH E9]
- Scematic representation for choice of design
- Trial design: steps 1 and 2
- Trial design: step 3
- Decision of balance
- Who is the decision maker?
- Define the difference (1)
- Choice of delta
- Define the difference (2)
- Define the difference (3)
- Trial design: step 5
- Factors reducing assay sensitivity
- Assay sensitivity: assumptions
- Is a placebo necessary to prove assay sensitivity?
- Analysis stage: step 5
- Confidence intervals
- Hypothesis testing (1)
- Hypothesis testing (2)
- Hypothesis testing (3)
- Hypothesis testing for non-inferiority
- Interpretation
- Nominal levels
- Analysis population (1)
- Analysis population (2)
- Analysis population (3)
- Superiority - non-inferiority (1)
- Superiority - non-inferiority (2)
- Illustrative example
- Two types of colonoscopy detecting colon polyps
- Colon polyps
- Appropriate control arm: step 1
- Superiority or equivalence: step 2
- Primary objective: step 2
- Defining delta: step 3
- Testing approach
- Assay sensitivity
- Summary
- Related guidances
- References (1)
- References (2)
- Hopefully, you are not here anymore
- Thank you
Topics Covered
- Equivalence trial study design
- Selection of an acceptable margin of equivalence/non-inferiority
- Selection of the control (placebo/active/both)
- Confidence interval or hypothesis testing
- Approach
- Analysis population
- Trial conduct
Links
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Talk Citation
Durkalski-Mauldin, V. (2007, October 1). Design and conduct of equivalence trials [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved November 14, 2024, from https://doi.org/10.69645/HZQT5643.Export Citation (RIS)
Publication History
Financial Disclosures
- Prof. Valerie Durkalski-Mauldin has not informed HSTalks of any commercial/financial relationship that it is appropriate to disclose.