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Saturday, July 25, 2020 9:16:31 PM
In my attempt to help you guys make informed calculations.. Have you seen the Protocol..to see what equations are to be used in Analysis..?? If not.. the most common ones used in the last 30 Clinical Trials I have completed are..
Primary Endpoints.....
Relative risk analysis from a Cochran-Mantel-Haenszel (Gamma squared)...The estimates of the hazard ratios and corresponding 95%CI using a Cox proportional hazards model..The time to the first composite Clinical Outcomeusing the stratified log rank test..
Survival in each arm using the Kaplan -Meier curves..along with corresponding 2-sided 95%CI for the estimates..
Secondary Endpoints...
If Primary Endpoint reaches statistical significance (p less than or equal to 0.001) The key secondary endpoints are tested at the following hierarchical order at the alpha = 0.001 level of significance until a test fails to meet the 0.001 significance level..
Mixed Model for Repeated Measurements..(MMRM)
Interim Analysis..
Alpha adjusted using the Bonferroni method..
The final Alpha using the method of LAN and DeMets with O Brien-Fleming boundaries to maintain an overall Alpha of 0.01 for the Study..
Phew..!!!
I hope I helped you paint that wall..
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