Hello,
This is a randomized drug study comprising three groups: a placebo group, a second group receiving a drug with a low dose, and a third group receiving the same drug with a higher dose. The objective is to calculate the sample size. The plan involves an annual rate of the primary composite endpoint of 15% in the placebo group, a 20% treatment effect in treatment group 1, and a 10% treatment effect in treatment group 2. The enrollment period spans 1.5 years, with a total study duration of 4 years, an annual rate of loss to follow-up of 1%, a 20% annual dropout rate in the treatment groups, and a 20% drop-in rate in the placebo group. Employing a two-sided log-rank test for equality of survival functions and accounting for planned interim analyses with an overall α level of 0.05, the goal is to determine the required number of patients to achieve approximately 80% and 90% power.. How to calculate that using Art in Stata? Thanks.
This is a randomized drug study comprising three groups: a placebo group, a second group receiving a drug with a low dose, and a third group receiving the same drug with a higher dose. The objective is to calculate the sample size. The plan involves an annual rate of the primary composite endpoint of 15% in the placebo group, a 20% treatment effect in treatment group 1, and a 10% treatment effect in treatment group 2. The enrollment period spans 1.5 years, with a total study duration of 4 years, an annual rate of loss to follow-up of 1%, a 20% annual dropout rate in the treatment groups, and a 20% drop-in rate in the placebo group. Employing a two-sided log-rank test for equality of survival functions and accounting for planned interim analyses with an overall α level of 0.05, the goal is to determine the required number of patients to achieve approximately 80% and 90% power.. How to calculate that using Art in Stata? Thanks.
