Clinical Trials: A Methodologic Perspective [NOOK Book]

Overview

"This Second Edition of the critically hailed Clinical Trials builds on the text's reputation as a straightforward and authoritative presentation of statistical methods for clinical trials. Readers are introduced to the fundamentals of design for various types of clinical trials and then skillfully guided through the complete process of planning the experiment, assembling a study cohort, assessing data, and reporting results. Throughout the process, the author alerts readers to problems that may arise during the course of the trial and provides
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Clinical Trials: A Methodologic Perspective

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Overview

"This Second Edition of the critically hailed Clinical Trials builds on the text's reputation as a straightforward and authoritative presentation of statistical methods for clinical trials. Readers are introduced to the fundamentals of design for various types of clinical trials and then skillfully guided through the complete process of planning the experiment, assembling a study cohort, assessing data, and reporting results. Throughout the process, the author alerts readers to problems that may arise during the course of the trial and provides commonsense solutions." The author bases the revisions and updates on his own classroom experience, as well as feedback from students, instructors, and medical and statistical professionals involved in clinical trials. The Second Edition greatly expands its coverage, ranging from statistical principles to controversial topics, including alternative medicine and ethics. At the same time, it offers more pragmatic advice for issues such as selecting outcomes, sample size, analysis, reporting, and handling allegations of misconduct.

The book contains black-and-white illustrations.

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Editorial Reviews

Booknews
A textbook for a half-semester course for students with a background in basic biostatistics, and a previous introductory course in clinical trials or research methods. Piantadosi oncology and biostatistics, Johns Hopkins U. explains the basic statistical methods used in clinical trials, encompassing such aspects as ethics, experiment design, bias and random error, sample size and power, and the study cohort. Includes a 3.5" disk for IBM compatibles. Annotation c. by Book News, Inc., Portland, Or.
From the Publisher
"…clearly written, practical presentations of the standard topics, and also fascinating discussion you won't find elsewhere…" (Journal of Clinical Research Best Practices, August 2007)

"…a very good addition to the clinical trials area." (Statistical Methods in Medical Research, October 2006)

"…an excellent reference for both clinicians and statisticians." (Journal of Biopharmaceutical Statistics, May/June 2006)

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Product Details

  • ISBN-13: 9781118625859
  • Publisher: Wiley
  • Publication date: 5/29/2013
  • Series: Wiley Series in Probability and Statistics
  • Sold by: Barnes & Noble
  • Format: eBook
  • Edition number: 2
  • Pages: 720
  • File size: 18 MB
  • Note: This product may take a few minutes to download.

Meet the Author

STEVEN PIANTADOSI, MD, Phd, is Professor of Oncology and Director of Biostatistics at the Johns Hopkins Oncology Center. He also holds appointments in the Departments of Biostatistics and Epidemiology at the Bloomberg School of Public Health at John Hopkins University. Dr. Piantadosi has taught clinical trials for seventeen years and is the author or coauthor of more than 250 scholarly articles.

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Table of Contents

1 Preliminaries 1
2 Clinical trials as research 9
3 Why clinical trials are ethical 29
4 Contexts for clinical trials 65
5 Statistical perspectives 107
6 Clinical trials as experimental designs 127
7 Random error and bias 167
8 Objectives and outcomes 187
9 Translational clinical trials 211
10 Dose-finding designs 223
11 Sample size and power 251
12 The study cohort 309
13 Treatment allocation 331
14 Treatment effects monitoring 355
15 Counting subjects and events 395
16 Estimating clinical effects 409
17 Prognostic factor analyses 453
18 Reporting and authorship 479
19 Factorial designs 501
20 Crossover designs 515
21 Meta-analyses 529
22 Misconduct and fraud in clinical research 539
A Data and programs 565
B Notation and terminology 569
C Abbreviations 587
D Nuremberg Code 591
E Declaration of Helsinki 593
F NCI data and safety monitoring policy 599
G NIH data and safety monitoring policy 605
H Royal Statistical Society code of conduct 609
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  • Anonymous

    Posted August 27, 2013

    Surgery room

    Nook clinic and hospital

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