Clinical trials handbook : design and conduct / Curtis L. Meinert.

Format:

Book

Author/Creator:

Meinert, Curtis L.

Contributor:

EBSCOhost.

Alumni and Friends Memorial Book Fund.

Language:

English

Subjects (All):

Drugs--Testing--Handbooks, manuals, etc.

Drugs.

Clinical trials--Handbooks, manuals, etc.

Clinical trials.

Drugs--Testing.

Genre:

Handbooks and manuals.

Physical Description:

1 online resource (599 pages)

Place of Publication:

Hoboken, N.J. : John Wiley, [2013]

System Details:

text file

Summary:

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. Book jacket.

Contents:

I General 1

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 Specifications 25

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 Funding 45

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 Administration 69

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 Control 129

46 Bias control procedures 131

47 Stratifications 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 Consents 159

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 Followup 195

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 Size 251

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 Processing 267

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 Centers 315

105 Center types 317

106 Centers 323

107 Center requirements 325

XIII Investigators/Study Staff 329

108 Investigator requirements 331

109 Clinic staffing requirements 333

110 Research group/Investigators 335

XIV Committees 337

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 Monitoring 371

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 Assurance 393

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 Analysis 413

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/Presentation 425

141 Publication 427

142 Publication policy 429

143 Authorship 431

144 Credits 435

145 Presentation policy 439

XIX Policies 441

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 Events 469

157 Adverse events 471

158 Adverse event reporting procedures 475

XXI Miscellaneous 479

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.

Notes:

Includes bibliographical references and index.

Machine generated contents note: Preface xiOn planning xiiiExplanatory notes, focus, and conventions xvI. General 31. Terminology 42. Definitions 63. Measurement units 84. Trial type 95. Design and flow schematics 126. Design and operating principles 137. Counting and analysis rules 148. Multi-study umbrella name 169. Study name 18II. Design specifications 2110. Objective 2211. Specific aims 2412. Experimental variable 2513. Treatment unit 2614. Primary outcome 2815. Outcome measures 3116. Design synopsis 33III. Funding 3717. Type of funding initiative 3818. Funding: Specifications 4019. Funding: Terminology 4220. Funding: Type 5021. Funding: Initiative 5122. Funding: Period 5323. Funding: Budget 5424. Funding: Mode 56IV. Treatment groups/treatment administration 5925. Study groups 6026. Comparison group 6227. Study treatments 6428. Test treatments 6629. Control/comparison treatment 6830. Placebo treatment 7531. Sham treatment 8032. Treatment modality 8233. Treatment schedule 8334. Treatment compliance measures 8535. Protocol overrides 8836. Protocol bailouts 90V. Masking 9337. Mask/masking: Definitions 9438. Masking principles 9739. Masking, censoring, and shielding specifications 9940. Drug masking procedure 10141. Drug packaging and labeling 10342. Drug supply 10643. Masking safeguards 10844. Unmasking treatment assignment 10945. Results blackouts 110VI. Bias and variance control 11346. Bias control procedures 11447. Stratification 11748. Variance control procedures 12049. Separations 122VII. Treatment assignment/randomization 12350. Assignment methods: Fixed vs adaptive 12451. Treatment assignment: Random vs nonrandom 12652. Randomization: Complete vs restricted 12953. Randomization unit 13254. Randomization: Procedures 134VIII. IRBs and consents 13555. IRBs 13656. IRBs: Models and procedures 13857. Consent 14358. Consent: Checklist 15059. Consent: Disclaimers and notifications 15360. Consent: Principles and purpose 15561. Consent: Process 15762. Consent: Types 16063. Consent: Questions and answers 162IX. Enrollment and followup 16764. Notation 16865. Timing conventions 17166. Required approvals, permissions, accesses, and supplies 17367. Start-up design 17568. Start-up checklist 17969. Recruitment design 18070. Enrollment goals 18271. Enrollment quotas 18472. Followup: Terminology 18973. Followup: Method 19374. Followup: Length 19575. Closeout design 19676. Missed visit 19977. Dropout 20078. Loss to followup 20479. Study timetable 20780. Critical event path analysis 20981. Eligibility criteria 21282. Exclusions from enrollment 21583. Eligibility and exclusions by reason 219X. Sample size 22184. Sample size: Design 22285. Sample size: Specifications 22686. Sample size: Calculation 22987. Fixed versus sequential sample size designs 23188. Fixed versus adaptive designs 23389. Designed subgroup comparisons 235XI. Data collection and processing 23990. Contact schedule 24091. Examinations/visits 24192. Examination/clinic visit schedule 24593. Data collection 24994. Data collection: Schedules and procedures 25295. Data flow 25596. Data processing procedures 25797. Laboratory tests 26098. Readings 26299. Tissue repositories 266100. Form design: Principles and procedures 268101. Time window specifications 272102. Data entry design 274103. Data sharing: Internal 280104. Data sharing: External 283XII. Study centers 287105. Center types 288106. Centers 291107. Center requirements 293XIII. Investigators/study staff 297108. Investigator requirements 298109. Clinic staffing requirements 300110. Research group/Investigators 302XIV. Committees 305111. Key committees 306112. Standing and working committees 307113. Committee rules and procedures 308114. Study officers 312115. Study chair/vice-chair 313116. Executive committee 317117. Executive committee members 319118. Steering committee 320119. Steering committee members 322120. Steering committee: Questions, answers, and observations 324121. Steering committee representation models 327XV. Treatment effects monitoring 331122. Treatment effects monitoring 332123. Treatment effects monitoring: Purpose 334124. Treatment effects monitoring: Approach 336125. Treatment effects monitoring: Masking 338126. Stopping rules and guidelines 340127. Treatment effects monitoring: Questions and answers 342128. Treatment effects monitoring committee 345129. Treatment effects monitoring committee: Questions and answers 347XVI. Quality control and assurance 351130. Quality control and assurance procedures 352131. Performance monitoring 356132. Training procedures 358133. Assurances and certifications 359134. Site visiting procedures 361135. Audit procedures 364XVII. Data analysis 367136. Analysis datasets 368137. Analysis questions regarding study results publications 370138. Frequentist vs Bayesian analysis 372139. Final analysis 374140. Subgroup analysis 376XVIII. Publication/presentation 379141. Publication 380142. Publication policy 382143. Authorship 384144. Credits 389145. Presentation policy 393XIX. Policies 395146. Policies 396147. Publicity policy 397148. Policy on access to study documents 398149. Policy on access to study data and results 400150. Policy on advertising for patients 403151. Policy on incentive payments 404152. Policy on payment of patient related travel expenses 406153. Ancillary study policy 407154. Policy on patient care related payments 409155. Policy on conflicts of interest 410156. Substudy policy 413XX. Adverse events 415157. Adverse events 416158. Adverse event reporting procedures 420XXI. Miscellaneous 423159. Key study documents 424160. Design synopsis 425161. Slide sets 426162. Study CV 427163. Study website 428164. Study history log 429165. Landmark events and dates 431166. Registration 433Appendices 435Appendix 1. Design summaries 437Appendix 2. Sample design slide sets 457Appendix 3. Template worksheets and slides 489References 505Index 516.

Electronic reproduction. Ipswich, MA Available via World Wide Web.

Description based on online resource; title from digital title page (viewed on Dec. 18, 2012).

Local Notes:

Acquired for the Penn Libraries with assistance from the Alumni and Friends Memorial Book Fund.

Other Format:

Print version: Meinert, Curtis L. Clinical trials handbook

ISBN:

9781118422878

9781118422823

1118422821

1118422872

Publisher Number:

99954897906

Access Restriction:

Restricted for use by site license.