국가임상시험지원재단

FDA 임상시험 종결점에 관한 지침(안)/

Multiple Endpoints in Clinical Trials Guidance for Industry

This guidance provides sponsors and review staff with the Agency's thinking about the problems posed by multiple endpoints in the analysis and interpretation of study results and how these problems can be managed in clinical trials for human drug, including drugs subject to licensing as biological products. Most clinical trials performed in drug development contain multiple endpoints to assess the effects of the drug and to document the ability of the drug to favorably affect one or more disease characteristics. As the number of endpoints analyzed in a single trial increases, the likelihood of making false conclusion about a drug's effects with respect to one or more of those endpoints becomes a concern if there is not appropriate adjustment for multiplicity . The purpose of this guidance is to describe various strategies for grouping and ordering endpoints for analysis and applying some well- recognized statistical methods for managing multiplicity within a study in order to control the chance of making erroneous conclusions has not been appropriately controlled can lead to false or misleading representations regarding a drug's effects.

Table of contents

Ⅰ. INTRODUCTION

Ⅱ. BACKGROUND AND SCOPE

Ⅲ. MULTIPLE ENDPOINTS: GENERAL PRINCIPLES

Ⅳ. METHODOLOGICAL

Ⅴ. SUMMARY

Ⅵ. GENERAL

링크: fda.gov