Planning a clinical trial with allowance for cost and patient recruitment rate

Abstract

This paper deals with: (1) estimation of the optimum clinical trial size minimizing the total cost, given types I and II errors, α, β and response rate difference, δ: (2) studying the test performance by calculating the operating characteristic curve in case of available fixed total cost, (3) mapping the future course of the patient recruitment plan by estimating recruitment rate and final intake based on enrollment to date, (4) projecting the recruitment duration and probability of achieving the contracted goal in case the recruitment rate is well established.