Translational and Experimental Clinical Research

Front Cover
Daniel P. Schuster, William J. Powers (MD.)
Lippincott Williams & Wilkins, 2005 - Medical - 490 pages

This volume is a comprehensive textbook for investigators entering the rapidly growing field of translational and experimental clinical research. The book offers detailed guidelines for designing and conducting a study and analyzing and reporting results and discusses key ethical and regulatory issues.

Chapters address specific types of studies such as clinical experiments in small numbers of patients, pharmacokinetics and pharmacodynamics, and gene therapy and pharmacogenomic studies. A major section describes modern techniques of translational clinical research, including gene expression, identifying mutations and polymorphisms, cloning, transcriptional profiling, proteomics, cell and tissue imaging, tissue banking, evaluating substrate metabolism, and in vivo imaging.

Contents

Defining the Research Question
3
Searching the Literature
15
Variables and Measurements
31
Study Eligibility and Participant Selection
45
Recruiting Research Participants
54
Reducing Bias
67
Observational Study Designs
73
Experimental Study Designs
84
Preparing for Gene Therapy Studies
237
Analyzing and Reporting Results
247
Hypothesis Testing and Summary Statistics
249
Group Comparisons
258
Regression
271
Multivariate Analysis
284
Biostatistical Consulting
297
Statistical Computing
303

Estimating Sample Size
97
Database Development
113
Case Report Form Development
122
Data Collection and Quality Control
136
Monitoring Experimental Interventions
152
SECTION II
154
Special Topics
161
Responsible Conduct of Research
163
Regulatory Oversight
176
Funding Clinical Research
189
Research Budgeting
198
Small Clinical Experiments
203
Clinical Studies in Pediatric Minority Populations
209
Pharmacokinetics and Pharmacodynamics
212
Gene Therapy and Pharmacogenomic Studies
223
Presenting Data in Manuscripts
308
Visual Presentation of Data
320
SECTION IV
322
Modern Techniques of Translational Clinical Research
331
Fundamentals of Gene Expression
333
Identifying Mutations and Polymorphisms
343
Cloning Methods
356
Transcriptional Profiling
369
Proteomics
385
Cell and Tissue Imaging Techniques
396
NonImaging Cell and Tissue Techniques and Tissue Banking
413
Evaluating Substrate Metabolism
435
Medical Images as Scientific Data
450
Index
465
Copyright

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