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Literature DB >> 16724486

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

Mark Chang¹, Shein-Chung Chow, Annpey Pong.

Abstract

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.

Mesh：

Year: 2006 PMID： 16724486 DOI： 10.1080/10543400600609718

Source DB: PubMed Journal: J Biopharm Stat ISSN： 1054-3406 Impact factor: 1.051

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Cited

12 in total

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Review 3. Controversies in Alzheimer's disease drug development.

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5. The utility of Google Trends data to examine interest in cancer screening.

Authors: M Schootman; A Toor; P Cavazos-Rehg; D B Jeffe; A McQueen; J Eberth; N O Davidson
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8. Missing steps in a staircase: a qualitative study of the perspectives of key stakeholders on the use of adaptive designs in confirmatory trials.

Authors: Munyaradzi Dimairo; Jonathan Boote; Steven A Julious; Jonathan P Nicholl; Susan Todd
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9. Cross-sector surveys assessing perceptions of key stakeholders towards barriers, concerns and facilitators to the appropriate use of adaptive designs in confirmatory trials.

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Review 10. Emerging technologies to measure neighborhood conditions in public health: implications for interventions and next steps.

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