16、MCP - Mod Procedure for Dose - Response Testing and Estimation

MCP - Mod Procedure for Dose - Response Testing and Estimation

1. Introduction

In drug development, a major issue in failed phase III programs is poor dose selection. This stems from insufficient understanding of the dose - response relationship (efficacy and safety) at the end of phase II. Selecting the appropriate dose(s) for confirmatory phase III trials is one of the most challenging decisions.

The high attrition rate in phase III studies is at least partly due to improper dose selection. Doses can be too low to provide adequate benefits or too high, leading to dose - related safety events. The key difficulty in choosing the right dose is the trade - off between desired and undesired effects.

Traditional dose - finding methods rely on mul