PhRMA Working Group on Adaptive Designs: Introduction to the Full White Paper

被引：19

作者：

Gallo, Paul ^{[1
]}

Krams, Michael ^{[1
]}

机构：

[1] Novartis Pharmacuet, Biostat & Stat Reporting, E Hanover, NJ 07936 USA

来源：

DRUG INFORMATION JOURNAL | 2006年 / 40卷 / 04期

关键词：

adaptive dose finding; seamless design; sample size reestimation; interim analyses;

D O I：

10.1177/216847900604000407

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

Pharmaceutical Research and Manufacturers of America (PhRMA) has formed a Working Group on Adaptive Designs. The group aims to contribute to a constructive dialogue on adaptive designs by engaging statisticians, clinicians, and other stakeholders in academia, regulatory agencies, and industry. Hopefully this will facilitate broader consideration and implementation of these designs. The papers that follow in this issue comprise the Full White Paper of the group and summarize its findings and recommendations from its first year of activity.

引用

页码：421 / 423

页数：3