Jump to ContentJump to Main Navigation
NeuroepidemiologyFrom principles to practice$
Users without a subscription are not able to see the full content.

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

Show Summary Details
Page of

PRINTED FROM OXFORD SCHOLARSHIP ONLINE (www.oxfordscholarship.com). (c) Copyright Oxford University Press, 2019. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in OSO for personal use. date: 20 October 2019

Clinical Trials in Neurology

Clinical Trials in Neurology

Chapter:
(p.399) 17 Clinical Trials in Neurology
Source:
Neuroepidemiology
Author(s):

Lorene M. Nelson

Caroline M. Tanner

Stephen K. Van Den Eeden

Valerie M. McGuire

Publisher:
Oxford University Press
DOI:10.1093/acprof:oso/9780195133790.003.17

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

Oxford Scholarship Online requires a subscription or purchase to access the full text of books within the service. Public users can however freely search the site and view the abstracts and keywords for each book and chapter.

Please, subscribe or login to access full text content.

If you think you should have access to this title, please contact your librarian.

To troubleshoot, please check our FAQs , and if you can't find the answer there, please contact us .