Handbook for Clinical Research

With over 80 information-packed chapters, Handbook for Clinical Research delivers the practical insights and expert tips necessary for successful research design, analysis, and implementation. Using clear language and an accessible bullet point format, the authors present the knowledge and expertise developed over time and traditionally shared from mentor to mentee and colleague to colleague. Organized for quick access to key topics and replete with practical examples, the book describes a variety of research designs and statistical methods and explains how to choose the best design for a particular project. Research implementation, including regulatory issues and grant writing, is also covered.The book opens with a section on the basics of research design, discussing the many ways in which studies can be organized, executed, and evaluated. The second section is devoted to statistics and explains how to choose the correct statistical approach and reviews the varieties of data types, descriptive and inferential statistics, methods for demonstrating associations, hypothesis testing and prediction, specialized methods, and considerations in epidemiological studies and measure construction. The third section covers implementation, including how to develop a grant application step by step, the project budget, and the nuts and bolts of the timely and successful completion of a research project and documentation of findings: procedural manuals and case report forms; collecting, managing and securing data; operational structure and ongoing monitoring and evaluation; and ethical and regulatory concerns in research with human subjects.With a concise presentation of the essentials for successful research, the Handbook for Clinical Research is a valuable addition to the library of any student, research professional, or clinician interested in expanding the knowledge base of his or her field.Key Features:Delivers the essential elements, practical insights, and trade secrets for ensuring successful research design, analysis, and implementation Presents the nuts and bolts of statistical analysis Organized for quick access to a wealth of information Replete with practical examples of successful research designs o from single case designs to meta-analysis - and how to achieve them Addresses research implementation including regulatory issues and grant writing

Section I: Design
1.Development and Testing of Treatments; 2. Qualitative Research; 3. Single-Case Experimental Designs; 4. Studies of Association; 5. Observational Studies: Retrospective versus Prospective; 6. Historical Controls; 7. Subject as Own Control; 8. Longitudinal Cohort versus Cross-Sectional Cohort Studies; 9. Survey Research; 10.Choice of Control Groups in Treatment Studies; 11. Randomization; 12. Special Issues in Randomized Controlled Trials; 13. Secondary Data Analysis; 14. Scoping Study; 15. Systematic Reviews; 16. Meta-Analysis; 17. Recommendations for Reporting Research Studies; 18. Evaluating Systematic Reviews and Developing Practice Guidelines
Section II: Statistics
19. Introduction; 20. Types of Data; 21. Descriptive Stastistics; 22. Data Distributions; 23. Samples and Populations; 24. Visual Display of Data; 25. Data Cleaning; 26. Missing Data and Implementation; 27.Estimation; 28.Hypothesis Testing; 29.Sample Size and Power; 30. Comparing Matched Samples with Continuous-type Outcomes: Two Groups; 31. Comparing Independent Samples with Continuous-type Outcomes: Two Groups; 32. Comparing Independent Samples for Continuous-type Outcomes: Three Groups or More; 33.Significance Tests: Categorical Data; 34. Correlation; 35. Simple Linear Regression; 36. Multiple Linear Regression; 37. Measures of Effect Sizes for Categorical Outcomes; 38. Logistic Regression; 39. Kaplan-Meier Estimator; 40. Log-Rank Test; 41.Proportional Hazards Model; 42. Longitudinal and Clustered Data; 43. Sources for Error: Selection Bias, Information Bias, and Confounding; 44. Mediation Analyses; 45. Epidemiology Study: Incidence and Prevalence; 46. Validity and Performance of Screening: Sensitivity, Specificity, Positive Predictive Value and Negative Predictive Value; 47. Statistical Tools for Agreement and Reliability Studies; 48. Classical Test Theory; 49. Item Response Theory
Section III: Implementation
Grant Proposals
50. Successful Grant Applications; 51. Sources of Research Funding; 52. Planning Grants; 53. Developing the Idea with Stakeholder Input; 54. Research Questions, Hypotheses, Aims and Abstracts; 55. Reviewing the Literature; 56. Background and Significance; 57. Preliminary Studies and Experience; 58. Methods and Design; 59. Types of Measures; 60. Letters of Support; 61. Budget and Budget Justification; 62.Pre-Award Management
Conducting the Research63. Post-Award Management; 64. Good Clinical Practices; 65. Research Misconduct; 66. Study Protocol; 67. Manual of Procedures; 68. Treatment Manuals; 69. Participant Recruitment and Enrollment; 70. Participant Retention; 71. Data Collection; 72. Case Report Forms; 73. Database Development; 74. Data Dictionary; 75. Data management; 76. Plan of Operation; 77.Evaluation; 78.Regulatory Binder and Essential Documents; 79. Adverse Events; 80. Protocol Deviations and Violations; 81. Data and Safety Monitoring; 82. Multicenter Trials; 83. Site Monitoring and Oversight