Good practices for adaptive clinical trials in pharmaceutical product development

Brenda Gaydos; Keaven M. Anderson; Donald Berry; Nancy Burnham; Christy Chuang-Stein; Jennifer Dudinak; Parvin Fardipour; Paul Gallo; Sam Givens; Roger Lewis; Jeff Maca; José Pinheiro; Yili Pritchett; Michael Krams

doi:10.1177/009286150904300503

Good practices for adaptive clinical trials in pharmaceutical product development

Brenda Gaydos, Keaven M. Anderson, Donald Berry, Nancy Burnham, Christy Chuang-Stein, Jennifer Dudinak, Parvin Fardipour, Paul Gallo, Sam Givens, Roger Lewis, Jeff Maca, José Pinheiro, Yili Pritchett, Michael Krams

Biostatistics

Research output: Contribution to journal › Review article › peer-review

64 Scopus citations

Abstract

This article is a summary of good adaptive practices for the planning and implementation of adaptive designs compiled from experiences gained in the pharmaceutical industry. The target audience is anyone involved in the planning and execution of clinical trials. The first step prior to planning an adaptive design is to assess the appropriateness of its use. Hence, strategic points to consider when assessing if an adaptive design is the right choice for a trial are discussed. In addition, strategic points for consideration at the design and implementation stage are included from operational, regulatory, clinical, and statistical perspectives. Good practices for trial simulation, trial documentation, and data monitoring committees are provided.

Original language	English (US)
Pages (from-to)	539-556
Number of pages	18
Journal	Drug Information Journal
Volume	43
Issue number	5
DOIs	https://doi.org/10.1177/009286150904300503
State	Published - Sep 2009

Keywords

Adaptive design
Best practices
Flexible design
Implementation
Planning

ASJC Scopus subject areas

Pharmacology (nursing)
Drug guides
Public Health, Environmental and Occupational Health
Pharmacology (medical)

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10.1177/009286150904300503

Cite this

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AU - Dudinak, Jennifer

AU - Fardipour, Parvin

AU - Gallo, Paul

AU - Givens, Sam

AU - Lewis, Roger

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AU - Pinheiro, José

AU - Pritchett, Yili

AU - Krams, Michael

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Good practices for adaptive clinical trials in pharmaceutical product development

Abstract

Keywords

ASJC Scopus subject areas

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