Fundamentals of Clinical Trials

Front Cover
Springer Science & Business Media, 1998 - 361 pages
Intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol, it is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The text uses numerous examples of published clinical trials from a variety of medical disciplines to meaningfully illustrate the fundamentals. Technical design issues such as sample size are considered, but the technical details have been suppressed as much as possible through the use of graphs and tables. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful both in a consulting and teaching capacity.

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Contents

Introduction to Clinical Trials
1
What Is the Question?
16
Basic Study Design
41
41
58
Blocked Randomization
64
Study Population
73
Mechanics of Randomization
74
Blindness
82
Data Collection and Quality Control
156
Assessing and Reporting Adverse Effects
170
Assessment of HealthRelated Quality of Life
185
Participant Adherence
204
17
220
Survival Analysis
223
Monitoring Response Variables
246
122
280

Sample Size
94
Dichotomous Response Variables
100
Sample Size Calculations for Continuous Response Variables
109
Sample Size for Testing Equivalency of Interventions
118
References
125
Baseline Assessment
130
Recruitment of Study Participants
140
Issues in Data Analysis
284
Closeout
323
Reporting and Interpreting of Results
333
Multicenter Trials
345
Index
357
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