Benefit-risk analysis: a proposal using quantitative methods

被引：43

作者：

Holden, WL ^{[1
]}

Juhaeri, J ^{[1
]}

Dai, WJ ^{[1
]}

机构：

[1] Aventis Pharmaceut, Bridgewater, NJ USA

来源：

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY | 2003年 / 12卷 / 07期

关键词：

benefit-risk analysis; pharmacoepidemiology; methods; number-needed-to-treat; number-needed-to-harm; minimum clinical efficacy analysis;

D O I：

10.1002/pds.887

中图分类号：

R1 [预防医学、卫生学];

学科分类号：

1004 ; 120402 ;

摘要：

This is the first part of a two-article series which will introduce the theory and practice of a proposed set of quantitative methods for benefit-risk analysis. Adjustments to number-needed-to-treat (NNT) analysis and a new method, minimum clinical efficacy (MCE) analysis are presented and critically discussed. The goal of these methods is to condense into a summary metric the benefit-risk profile of a product so that manufacturers, regulators, clinicians and patients can better understand and participate in risk management.. A second article will present examples of these methods. Copyright (C) 2003 John Wiley Sons, Ltd.

引用

页码：611 / 616

页数：6

共 20 条

[1] RISK AND BENEFIT EVALUATION IN DEVELOPMENT OF PHARMACEUTICAL PRODUCTS [J].