Question
Consider a study comparing patients groups with pancreatic cancer, planned to compare overall survival of patients receiving an experimental new treatment (group 2) versus patients
Consider a study comparing patients groups with pancreatic cancer, planned to compare overall survival of patients receiving an experimental new treatment (group 2) versus patients receiving the standard treatment (group 1). Investigators are willing to enroll up to 200 patients and randomly assign patients to new or standard treatment, with allocation ratio 1:1. The literature reports median survival under group 1 of 10 months. Group 2 is expected to increase median survival to 15 months or better. For sample size and power calculation, assume planned patient accrual of 12 months, minimum follow-up of 18 months, no losses to follow-up in any treatment group, and a two-sided significance level of 5%. The investigators revised their beliefs, and now the expected median is 14 months in the new treatment. With 100 patients per group, what is the power to detect the 40%, higher median survival underthe new treatment, assuming median survival of 10 months for the standard treatment and all other parameters unchanged? Based on all calculations and any other additional calculations, what would be your advice to the investigator? The hazard ratio is 0.667. The hazard rate for group 1 = 0.069 and group 2 = 0.046
Step by Step Solution
There are 3 Steps involved in it
Step: 1
Get Instant Access to Expert-Tailored Solutions
See step-by-step solutions with expert insights and AI powered tools for academic success
Step: 2
Step: 3
Ace Your Homework with AI
Get the answers you need in no time with our AI-driven, step-by-step assistance
Get Started