Taking the long view: How to design a series of Phase III trials to maximize cumulative therapeutic benefit Academic Article uri icon

Overview

MeSH Major

  • Clinical Trials, Phase III as Topic
  • Neoplasms
  • Research Design

abstract

  • It is worthwhile to consider a design paradigm that seeks to maximize the expected survival benefit across a series of trials, over a longer research horizon. In today's environment of constrained, biomarker-selected populations, our results indicate that smaller sample sizes and larger α values lead to greater long-term survival gains compared to traditional large trials designed to meet stringent criteria with a low efficacy bar.

publication date

  • June 2012

Research

keywords

  • Academic Article

Identity

Language

  • eng

PubMed Central ID

  • PMC3904223

Digital Object Identifier (DOI)

  • 10.1177/1740774512443430

PubMed ID

  • 22569743

Additional Document Info

start page

  • 283

end page

  • 92

volume

  • 9

number

  • 3