Curtis L. Meinert

Clinical Trials Handbook (eBook, ePUB)

Design and Conduct

• Format: ePub

Produktbeschreibung

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.

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Produktdetails

• Verlag: John Wiley & Sons
• Seitenzahl: 600
• Erscheinungstermin: 10. Oktober 2012
• Englisch
• ISBN-13: 9781118422793
• Artikelnr.: 37364182

Autorenporträt

CURTIS L. MEINERT, PhD, is Professor in the Departments of Epidemiology and Biostatistics at the Johns Hopkins Bloomberg School of Public Health, where he served as founder of the Johns Hopkins Center for Clinical Trials. He is a Fellow of the American College of Epidemiology, the American Association for the Advancement of Science, the American Heart Association, and the Society for Clinical Trials. Dr. Meinert has focused his research on the methodological issues in clinical trials, including their design, conduct, policy, and practice. He is the author of Clinical Trials Dictionary: Terminology and Usage Recommendations, Second Edition (Wiley).

Inhaltsangabe

Acknowledgments 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. Multi-study 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. Start-up design 203 68. Start-up 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. Investigator requirements 331 109. Clinic
staffing requirements 333 110. Research group/Investigators 335 XIV.
Committees337 111. Key Committees 339 112. Standing and working committees
341 113. Committee rules and procedures 343 114. Study officers 347 115.
Study chair/vice-chair 349 116. Executive committee 353 117. Executive
committee members 357 118. Steering committee 359 119. Steering committee
members 361 120. Steering committee: Questions, answers, and observations
363 121. Steering committee representation models 367 XV. Treatment Effects
Monitoring371 122. Treatment effects monitoring 373 123. Treatment effects
monitoring: Purpose 375 124. Treatment effects monitoring: Approach 377
125. Treatment effects monitoring: Masking 379 126. Stopping rules and
guidelines 381 127. Treatment effects monitoring: Questions and answers 383
128. Treatment effects monitoring committee 387 129. Treatment effects
monitoring committee: Questions and answers 391 XVI. Quality Control and
Assurance393 130. Quality control and assurance procedures 395 131.
Performance monitoring 399 132. Training procedures 401 133. Assurances and
certifications 403 134. Site visiting procedures 405 135. Audit procedures
409 XVII. Data Analysis413 136. Analysis datasets 415 137. Analysis
questions regarding study results publications 417 138. Frequentist vs.
Bayesian analysis 419 139. Final analysis 421 140. Subgroup analysis 423
XVIII. Publication/Presentation425 141. Publication 427 142. Publication
policy 429 143. Authorship 431 144. Credits 435 145. Presentation policy
439 XIX. Policies441 146. Policies 443 147. Publicity policy 445 148.
Policy on access to study documents 447 149. Policy on access to study data
and results 449 150. Policy on advertising for patients 453 151. Policy on
incentive payments 455 152. Policy on payment of patient-related travel
expenses 457 153. Ancillary study policy 459 154. Policy on
patient-care-related payments 461 155. Policy on conflicts of interest 463
156. Substudy policy 467 XX. Adverse Events469 157. Adverse events 471 158.
Adverse event reporting procedures 475 XXI. Miscellaneous479 159. Key study
documents 481 160. Design synopsis 483 161. Slide sets 485 162. Study CV
487 163. Study website 489 164. Study history log 491 165. Landmark events
and dates 493 166. Registration 495 Appendices497 Appendix 1. Design
summaries for selected finished trials 499 Appendix 2. Sample design slide
sets 517 Appendix 3. Template summary worksheet 537 References 551 Index
557

Rezensionen

"In summary, Clinical Trials Handbook is a user friendly book with numerous examples from the real clinical trials. It outlines all steps employed in setting up and running clinical trials, from budgeting and fundraising to publishing the results. It is an asset to 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." (Journal of Biopharmaceutical Statistics, 1 April 2013)