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  • Format: PDF


A systematic approach to all aspects of designing andconducting clinical trials The success or failure of clinical trials hinges on hundreds ofdetails that need to be developed, often under less than idealconditions. Written by one of the world's leading trialists,Clinical Trials Handbook: Design and Conduct providesclinicians with a complete guide to designing, conducting, andevaluating clinical trials--teaching them how to simplify theprocess and avoid costly mistakes. The author draws on his extensive clinical trials experience tooutline all steps employed in setting up and running…mehr

Produktbeschreibung
A systematic approach to all aspects of designing andconducting clinical trials The success or failure of clinical trials hinges on hundreds ofdetails that need to be developed, often under less than idealconditions. Written by one of the world's leading trialists,Clinical Trials Handbook: Design and Conduct providesclinicians with a complete guide to designing, conducting, andevaluating clinical trials--teaching them how to simplify theprocess and avoid costly mistakes. The author draws on his extensive clinical trials experience tooutline all steps employed in setting up and running clinicaltrials, from budgeting and fundraising to publishing the results.Along the way, practical advice is offered while also addressing amix of logistical, ethical, psychological, behavioral, andadministrative issues inherent to clinical trials. Topics ofcoverage include: * Protocols for drug masking, controls, and treatmentrandomization * Consent, enrollment, eligibility, and follow-up procedures * Different types of sample size design and data collection andprocessing * Working with study centers, research staff, and variouscommittees * Monitoring treatment effects and performance, and ensuringquality control * Data analysis and access policies for study data anddocuments Clinical Trials Handbook is invaluable for practicingclinicians and trialists who would like to learn more about orimprove their understanding of the design and execution of clinicaltrials. The book is also an excellent supplement for courses onclinical trials at the graduate level.

Dieser Download kann aus rechtlichen Gründen nur mit Rechnungsadresse in A, B, BG, CY, CZ, D, DK, EW, E, FIN, F, GR, H, IRL, I, LT, L, LR, M, NL, PL, P, R, S, SLO, SK ausgeliefert werden.

  • Produktdetails
  • Verlag: John Wiley & Sons
  • Seitenzahl: 600
  • Erscheinungstermin: 1. Oktober 2012
  • Englisch
  • ISBN-13: 9781118422823
  • Artikelnr.: 37364944
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)