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NeuroepidemiologyFrom principles to practice$
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Lorene M. Nelson, Caroline M. Tanner, Stephen Van Den Eeden, and Valarie M. McGuire

Print publication date: 2004

Print ISBN-13: 9780195133790

Published to Oxford Scholarship Online: September 2009

DOI: 10.1093/acprof:oso/9780195133790.001.0001

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PRINTED FROM OXFORD SCHOLARSHIP ONLINE (www.oxfordscholarship.com). (c) Copyright Oxford University Press, 2020. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in OSO for personal use. date: 08 July 2020

Clinical Trials in Neurology

Clinical Trials in Neurology

(p.399) 17 Clinical Trials in Neurology

Lorene M. Nelson

Caroline M. Tanner

Stephen K. Van Den Eeden

Valerie M. McGuire

Oxford University Press

This chapter provides extensive coverage of concepts related to controlled clinical trials in neurology. It describes the main issues in clinical trial design, conduct, and analysis, by examples from neurological research. It begins with a summary of the objectives of Phase I through Phase IV trials, followed by a discussion of the commonly used study designs for clinical trials (parallel group design, factorial design, crossover design, N-of-one design). It then describes important principles for the conduct of clinical trials, including methods for recruitment and retention of clinical trial subjects, approaches to minimizing bias due to unblinding, and techniques for monitoring compliance and adverse events. It discusses methods of randomization and choice of primary and secondary measures of treatment outcome and summarizes statistical approaches to clinical trial data, including intent-to-treat analyses, explanatory analyses, per protocol analyses, and on-treatment analyses. Methods for subgroup analyses and planning of interim analyses are also discussed. One section of the chapter is devoted to ethics of controlled clinical trials.

Keywords:   clinical trial design, parallel group design, factorial design, crossover design, N-of-one design, subject retention, blinding, compliance, adverse events, randomization

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