Calculate Sample size for non-inferiority clinical trial (with given Hazard ratio margin)

Minhtrang — Mon, 19 Jul 2021 09:15:59 GMT

Hi,

Could anyone show me how to calculate sample size for a non-inferiority clinical trial with given information as following?

"The primary hypothesis aims to show non-inferiority on 3P-MACE for empagliflozin versus placebo based on a non-inferiority margin of < 1.3 (upper limit of the adjusted 95% confidence interval (CI)) for the hazard ratio. The upper limit of the adjusted 95% CI for the HR of <1.3 was based on FDA guidance for CV trials evaluating new anti-hyperglycemic therapies for T2DM [9]. Patients who receive either 10 mg or 25 mg of empagliflozin will be pooled into a common treatment group for the purposes of the primary analysis. A 4-step hierarchical testing strategy will be followed: 1) non-inferiority test of the primary outcome (3P-MACE), 2) non-inferiority test of the key secondary outcome (4P-MACE), 3) superiority test of the primary outcome (3P-MACE) and 4) superiority test of the key secondary outcome (4P-MACE). A minimum of 691 confirmed primary outcome events are required to provide 90% power with a one-sided α level of 0.025, assuming equal risk between the placebo and empagliflozin groups. With a minimum of 691 events, the trial will also have at least 80% power to detect a hazard ratio of 0.785 (corresponding to a 21.5% risk reduction in CV outcome events) for the primary outcome."

So actually how to get the number of 691 as stated in the article?

Thanks a lot for your kinda help.

Trang

topic Calculate Sample size for non-inferiority clinical trial (with given Hazard ratio margin) in Statistical Procedures

Calculate Sample size for non-inferiority clinical trial (with given Hazard ratio margin)