A systematic approach to all aspects of designing and conducting clinical trials The success or failure of clinical trials hinges on hundreds of details that need to be developed, often under less than ideal conditions. Written by one of the world's leading trialists, Clinical Trials Handbook: Design and Conduct provides clinicians with a complete guide to designing, conducting, and evaluating clinical trials--teaching them how to simplify the process and avoid costly mistakes. The author draws on his extensive clinical trials experience to outline all steps employed in setting up and running clinical trials, from budgeting and fundraising to publishing the results. Along the way, practical advice is offered while also addressing a mix of logistical, ethical, psychological, behavioral, and administrative issues inherent to clinical trials. Topics of coverage include: * Protocols for drug masking, controls, and treatment randomization * Consent, enrollment, eligibility, and follow-up procedures * Different types of sample size design and data collection and processing * Working with study centers, research staff, and various committees * Monitoring treatment effects and performance, and ensuring quality control * Data analysis and access policies for study data and documents Clinical Trials Handbook is invaluable for practicing clinicians and trialists who would like to learn more about or improve their understanding of the design and execution of clinical trials. The book is also an excellent supplement for courses on clinical trials at the graduate level.

InhaltsangabeAcknowledgments xi Preface xiii On planning xv Explanatory notes, focus, and conventions xvii Abbreviations and designations xxi I. General1 1. Terminology 3 2. Definitions 5 3. Measurement units 7 4. Trial type 9 5. Design and flow schematics 13 6. Design and operating principles 15 7. Counting and analysis rules 17 8. Multistudy umbrella name 19 9. Study name 21 II. Design Specifications25 10. Objective 27 11. Specific aims 29 12. Experimental variable 31 13. Treatment unit 33 14. Primary outcome 35 15. Outcome measures 39 16. Design synopsis 41 III. Funding45 17. Type of funding initiative 47 18. Funding: Specifications 49 19. Funding: Terminology 51 20. Funding: Type 59 21. Funding: Initiative 61 22. Funding: Period 63 23. Funding: Budget 65 24. Funding: Mode 67 IV. Treatment Groups/Treatment Administration69 25. Study groups 71 26. Comparison group 73 27. Study treatments 75 28. Test treatments 77 29. Control/comparison treatment 79 30. Placebo treatment 87 31. Sham treatment 91 32. Treatment modality 93 33. Treatment schedule 95 34. Treatment compliance measures 97 35. Protocol overrides 101 36. Protocol bailouts 103 V. Masking 105 37. Mask/masking: Definitions 107 38. Masking principles 111 39. Masking, censoring, and shielding specifications 113 40. Drug masking procedure 115 41. Drug packaging and labeling 117 42. Drug supply 121 43. Masking safeguards 123 44. Unmasking treatment assignment 125 45. Results blackouts 127 VI. Bias and Variance Control129 46. Bias control procedures 131 47. Stratification 135 48. Variance control procedures 139 49. Separations 141 VII. Treatment Assignment/Randomization 143 50. Assignment methods: Fixed vs. adaptive 145 51. Treatment assignment: Random vs. nonrandom 147 52. Randomization: Complete vs. restricted 151 53. Randomization unit 155 54. Randomization: Procedures 157 VIII. IRBs and Consents159 55. IRBs 161 56. IRBs: Models and procedures 163 57. Consent 169 58. Consent: Checklist 177 59. Consent: Disclaimers and notifications 181 60. Consent: Principles and purpose 183 61. Consent: Process 185 62. Consent: Types 189 63. Consent: Questions and answers 191 IX. Enrollment and Followup195 64. Notation 197 65. Timing conventions 199 66. Required approvals, permissions, accesses, and supplies 201 67. Startup design 203 68. Startup checklist 207 69. Recruitment design 209 70. Enrollment goals 211 71. Enrollment quotas 213 72. Followup: Terminology 217 73. Followup: Method 221 74. Followup: Length 223 75. Closeout design 225 76. Missed visit 229 77. Dropout 231 78. Loss to followup 235 79. Study timetable 239 80. Critical event path analysis 241 81. Eligibility criteria 243 82. Exclusions from enrollment 245 83. Eligibility and exclusions by reason 249 X. Sample Size251 84. Sample size: Design 253 85. Sample size: Specifications 257 86. Sample size: Calculation 259 87. Fixed vs. sequential sample size designs 261 88. Fixed vs. adaptive designs 263 89. Designed subgroup comparisons 265 XI. Data Collection and Processing267 90. Contact schedule 269 91. Examinations/visits 271 92. Examination/clinic visit schedule 275 93. Data collection 279 94. Data collection: Schedules and procedures 281 95. Data flow 283 96. Data processing procedures 285 97. Laboratory tests 287 98. Readings 289 99. Tissue repositories 293 100. Form design: Principles and procedures 295 101. Time window specifications 299 102. Data entry design 301 103. Data sharing: Internal 307 104. Data sharing: External 311 XII. Study Centers315 105. Center types 317 106. Centers 323 107. Center requirements 325 XIII. Investigators/Study Staff329 108. Investig

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