Non-inferiority & Equivalence Studies

The aim of a non-inferiority study is to prove that a new (generic) drug is NOT WORSE THAN the classic treatment (the brand). Fulfilling non-inferiority should never be interpreted those treatments are equal. An equivalence study is analyzed as TWO NON-INFERIORITY STUDIES; each aiming to prove that one treatment is not worse than the other.

Workshop items:

• Understand the difference between the superiority, the non-inferiority & the equivalence study
• Calculate the unilateral 95% & the bilateral 90% confidence intervals
• Choose the non-inferiority margin & the equivalence limit
• Calculate sample size
• Analyze by Intention to treat & per protocol
• Interpret the results & appreciate limitations

Dates

Sat 25 Jan: 7 – 9 PM

Tue 28 Jan: 7 – 9 PM

Sat 1 Feb: 7 – 9 PM

Fees: 1100 EGP

Check the Research Design Package offer

1 Course: 1100 EGP

2 Courses: 1900 instead of 2200 EGP

3 Courses 2600 instead of 3300 EGP

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