SECTION I: Planning and Designing Clinical Research 1

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

Estimating Sample Size 97

Database Development 113

Case Report Form Development 122

Data Collection and Quality Control 136

Monitoring Experimental Interventions 152

SECTION II: 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

Preparing for Gene Therapy Studies 237

SECTION III: Analyzing and Reporting Results 247

Overview: Hypothesis Testing and Summary Statistics 249

Group Comparisons 258

Regression 271

Multivariate Analysis 284

Biostatistical Consulting 297

Statistical Computing 303

Presenting Data in Manuscripts 308

Visual Presentation of Data 320

SECTION IV: 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

Non-Imaging Cell and Tissue Techniques and Tissue Banking 413

Evaluating Substrate Metabolism 435

Medical Images as Scientific Data 450 Index 465