Introduction

Simon’s two-stage design is used to minimize the expected sample size when the true response is less than some pre-determined uninterested level \(\pi_0\) (Simon 1989).

Basic Theory

Consider again the basic statistical model, in which we have a random experiment that results in an observable random variable \({X}\) taking values in a set \(S\). Once again, the experiment is typically to sample $n $objects from a population and record one or more measurements for each item.

Background

Issue of analysis methods

Recently, we received FDA response for the model selection. We tried to use a logistic regression model with baseline scores as the covariate to estimate the odds ratio (OR). The objective is to show the superiority on a binary endpoint.

A simple review of ANCOVA model based on the workshop by Naitee Ting.

Compare Posterior Probability to the Predictive Probability. Trial design tool is available on https://trialdesign.org/.

Compare BOP2 (Bayesian optimal phase II) design to the design using Predictive Probability. Trial design tool is available on https://trialdesign.org/.

This post reproduces the results from the presentation Sequential Enrichment Designs for Early Phase Clinical Trials.

Introduction

This document aims to replicate the results from the paper:

Mitchell PD. A Bayesian single-arm design using predictive probability monitoring. Biom Biostat Int J. 2018;7(4):299-309. DOI: 10.15406/bbij.2018.07.00222 link