Translational and Experimental Clinical Research

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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.

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Product Details

  • ISBN-13: 9780781755658
  • Publisher: Lippincott Williams & Wilkins
  • Publication date: 6/28/2005
  • Edition description: New Edition
  • Pages: 464
  • Product dimensions: 7.00 (w) x 10.10 (h) x 1.20 (d)

Table of Contents

  1. SECTION I: Planning and Designing Clinical Research 1

  2. Defining the Research Question 3
  3. Searching the Literature 15
  4. Variables and Measurements 31
  5. Study Eligibility and Participant Selection 45
  6. Recruiting Research Participants 54
  7. Reducing Bias 67
  8. Observational Study Designs 73
  9. Experimental Study Designs 84
  10. Estimating Sample Size 97
  11. Database Development 113
  12. Case Report Form Development 122
  13. Data Collection and Quality Control 136
  14. Monitoring Experimental Interventions 152

    SECTION II: Special Topics 161

  15. Responsible Conduct of Research 163
  16. Regulatory Oversight 176
  17. Funding Clinical Research 189
  18. Research Budgeting 198
  19. "Small" Clinical Experiments 203
  20. Clinical Studies in Pediatric Minority Populations 209
  21. Pharmacokinetics and Pharmacodynamics 212
  22. Gene Therapy and Pharmacogenomic Studies 223
  23. Preparing for Gene Therapy Studies 237

    SECTION III: Analyzing and Reporting Results 247

  24. Overview: Hypothesis Testing and Summary Statistics 249
  25. Group Comparisons 258
  26. Regression 271
  27. Multivariate Analysis 284
  28. Biostatistical Consulting 297
  29. Statistical Computing 303
  30. Presenting Data in Manuscripts 308
  31. Visual Presentation of Data 320

    SECTION IV: Modern Techniques of Translational Clinical Research 331

  32. Fundamentals of Gene Expression 333
  33. Identifying Mutations and Polymorphisms 343
  34. Cloning Methods 356
  35. Transcriptional Profiling 369
  36. Proteomics 385
  37. Cell and Tissue Imaging Techniques 396
  38. Non-Imaging Cell and Tissue Techniques and Tissue Banking 413
  39. Evaluating Substrate Metabolism 435
  40. Medical Images as Scientific Data 450 Index 465
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