Translational and Experimental Clinical ResearchDaniel P. Schuster, William J. Powers (MD.) 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 |
| 465 | |





