Translational and Experimental Clinical Research

Translational and Experimental Clinical Research

by Daniel P. Schuster
     
 

ISBN-10: 0781755654

ISBN-13: 9780781755658

Pub. Date: 06/28/2005

Publisher: Lippincott Williams & Wilkins

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

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Overview

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.

Product Details

ISBN-13:
9780781755658
Publisher:
Lippincott Williams & Wilkins
Publication date:
06/28/2005
Edition description:
New Edition
Pages:
464
Product dimensions:
7.00(w) x 10.10(h) x 1.20(d)

Related Subjects

Table of Contents


    SECTION I: Planning and Designing Clinical Research 1

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

    SECTION II: Special Topics 161

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

    SECTION III: Analyzing and Reporting Results 247

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

    SECTION IV: Modern Techniques of Translational Clinical Research 331

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

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