Adaptive design in clinical research: issues, opportunities, and recommendations.

Published

Journal Article

The issues and opportunities of adaptive designs are discussed. Starting with the definitions of an adaptive design, its validity and integrity are discussed. The three key components of an adaptive design, i.e., Type I error control, p-value adjustment, and unbiased estimation and confidence interval are addressed. Various seamless designs are investigated. Recommendations are made in the following aspects: study planning, trial monitoring, analysis and reporting, trial simulation, and regulatory perspectives.

Full Text

Duke Authors

Cited Authors

  • Chang, M; Chow, S-C; Pong, A

Published Date

  • May 2006

Published In

Volume / Issue

  • 16 / 3

Start / End Page

  • 299 - 309

PubMed ID

  • 16724486

Pubmed Central ID

  • 16724486

International Standard Serial Number (ISSN)

  • 1054-3406

Digital Object Identifier (DOI)

  • 10.1080/10543400600609718

Language

  • eng

Conference Location

  • England