Translational And Experimental Clinical Research

by Schuster, Daniel P.; Powers, William J.; Castro, Mario; Shannon, William; Saffitz, Jeffrey E.

• ISBN13: 9780781755658
• ISBN10: 0781755654
• Edition: 1st
• Format: Hardcover
• Copyright: 2005-06-25
• Publisher: LWW

Summary

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.

Table of Contents

Introduction	xv
SECTION I Planning and Designing Clinical Research	1	(160)
Defining the Research Question	3	(12)
Searching the Literature	15	(16)
Variables and Measurements	31	(14)
Study Eligibility and Participant Selection	45	(9)
Recruiting Research Participants	54	(13)
Reducing Bias	67	(6)
Observational Study Designs	73	(11)
Experimental Study Designs	84	(13)
Estimating Sample Size	97	(16)
Database Development	113	(9)
Case Report Form Development	122	(14)
Data Collection and Quality Control	136	(16)
Monitoring Experimental Interventions	152	(9)
SECTION II Special Topics	161	(86)
Responsible Conduct of Research	163	(13)
Regulatory Oversight	176	(13)
Funding Clinical Research	189	(9)
Research Budgeting	198	(5)
``Small'' Clinical Experiments	203	(6)
Clinical Studies in Pediatric Minority Populations	209	(3)
Pharmacokinetics and Pharmacodynamics	212	(11)
Gene Therapy and Pharmacogenomic Studies	223	(14)
Preparing for Gene Therapy Studies	237	(10)
SECTION III Analyzing and Reporting Results	247	(84)
Overview: Hypothesis Testing and Summary Statistics	249	(9)
Group Comparisons	258	(13)
Regression	271	(13)
Multivariate Analysis	284	(13)
Biostatistical Consulting	297	(6)
Statistical Computing	303	(5)
Presenting Data in Manuscripts	308	(12)
Visual Presentation of Data	320	(11)
SECTION IV Modern Techniques of Translational Clinical Research	331	(134)
Fundamentals of Gene Expression	333	(10)
Identifying Mutations and Polymorphisms	343	(13)
Cloning Methods	356	(13)
Transcriptional Profiling	369	(16)
Proteomics	385	(11)
Cell and Tissue Imaging Techniques	396	(17)
Non-Imaging Cell and Tissue Techniques and Tissue Banking	413	(22)
Evaluating Substrate Metabolism	435	(15)
Medical Images as Scientific Data	450	(15)
Index	465