| Key multiplicity issues in clinical drug development. | |
| | |
MedLine Citation:
|
PMID: 23044723 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
|
Much progress has been made over the past decade with the development of novel methods for addressing increasingly more complex multiplicity problems arising in confirmatory Phase III clinical trials. This includes traditional problems with a single source of multiplicity, for example, analysis of multiple endpoints or dose-placebo contrasts. In addition, more advanced problems with several sources of multiplicity have attracted attention in clinical drug development. These problems include two or more families of objectives such as multiple endpoints evaluated at multiple dose levels or in multiple patient populations. This paper provides a review of concepts that play a central role in defining and solving multiplicity problems (error rate definitions) and introduces main classes of multiple testing procedures widely used in clinical trials (nonparametric, semiparametric, and parametric procedures). The paper also presents recent advances in multiplicity research, including gatekeeping procedures for clinical trials with multiple sets of objectives. The concepts and methods introduced in the paper are illustrated using several case studies on the basis of real clinical trials. Software implementation of commonly used multiple testing and gatekeeping procedures is discussed. Copyright © 2012 John Wiley & Sons, Ltd. |
| | |
Authors:
|
Alex Dmitrienko; Ralph B D'Agostino; Mohammad F Huque |
Related Documents
:
|
23271773 - Improving the communication of benefits and harms of treatment strategies: decision aid... 23381523 - Decision aids: when 'nudging' patients to make a particular choice is more ethical than... 19351893 - The stability of aid and its function in class-switching are critically sensitive to th... |
Publication Detail:
|
Type: JOURNAL ARTICLE Date: 2012-10-9 |
Journal Detail:
|
Title: Statistics in medicine Volume: - ISSN: 1097-0258 ISO Abbreviation: Stat Med Publication Date: 2012 Oct |
Date Detail:
|
Created Date: 2012-10-9 Completed Date: - Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 8215016 Medline TA: Stat Med Country: - |
Other Details:
|
Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
|
Copyright © 2012 John Wiley & Sons, Ltd. |
Affiliation:
|
Quintiles, Inc., Durham, NC, U.S.A.. alex.dmitrienko@quintiles.com. |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
|
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Management of toxicities associated with high-dose interleukin-2 and biochemotherapy.
Next Document: Education: DNA replication using microscale natural convection.