Fundamental concepts for new clinical trialists:
Gespeichert in:
| Hauptverfasser: | , |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Boca Raton, FL [u.a.]
CRC Press
2016
|
| Schriftenreihe: | Chapmann & Hall/CRC biostatistics series
|
| Schlagworte: | |
| Online-Zugang: | Klappentext Inhaltsverzeichnis |
| Beschreibung: | XIX, 348 S. Ill., graph. Darst. |
| ISBN: | 9781420090871 1420090879 |
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| adam_text | Statistics
Fundamental Concepts for New Clinical Trialists describes the core scien-
tific concepts of designing, data monitoring, analyzing, and reporting clinical tri-
als as well as the practical aspects of trials not typically discussed in statistical
methodology textbooks.
The first section of №e book provides background information about clinical
trials. It defines and compares clinical trials to other types of research studies
and discusses cttnical trial phases, registration, the protocol document, ethi-
cal issues, product development, and regulatory processes. It also includes a
special chapter outlining the valuable attributes that statisticians can develop to
maximize their contributions to a clinical trial.
The second section examines scientific issues faced in each progressive step
of a clinical trial. It covers issues in trial design, such as randomization, blind-
ing. control group selection, endpoint selection, superiority versus noninferior-
ity. and parallel group versus crossover designs: data monitoring; analyses of
efficacy, safety, and benefit-risk; and the reporting/publication of clinical trial
results.
Features
• Presents fundamental scientific issues and practical aspects of clinical
trials
• Provides classroom-tested material for a course on clinical trials suitable
for anyone working in this area, including statisticians, clinicians, data
managers, medical officers, medical writers, and site personnel
• Offers first-hand perspectives on reat-worid issues, such as common and
challenging clinical trial designs, the use of data monitoring committees,
benefit-risk evaluation, and the proper reporting of clinical trial results in
the medical literature
• Includes a special chapter on becoming a more effective clinical trial stat-
istician
As clinical trials remain the gold standard research studies for evaluating the ef-
fects of a medical intervention, newcomers to the field must have a fundamental
understanding of the concepts to tackle real-world issues in ail stages of trials.
Drawing on their experiences m academia and industry, the authors provide a
foundation for understanding the fundamental concepts necessary for working
in clmtcaJ trials.
Contents
Preface..............................................................xv
Authors ............................................................xix
Section I Background
1 Clinical Trials...................................................3
1.1 Introduction..........*......................................3
1.2 Phases....................................*..................8
1.3 Protocol................................................ 11
1.4 Clinical Trial Registration............................... 14
1.5 Ethical Issues..............................*...............16
1.5.1 Historical Ethical Failures........................ 17
1.5.2 Landmark Documents...................................17
1.5.3 Institutional Review Boards..........................18
1.5.4 Informed Consent................................. 20
1.5.5 Modem Cases of Negligence........................ 21
1.5.6 Statistical Ethics...*...............................21
References.......................*...............................22
2 Product Development Process.........................*............25
2.1 The Drug Label......*................................... ..26
2.2 Nonclinical Development .....................*..............27
2.2.1 Pharmacology.............*.*.........................27
2.2.2 Toxicology/Drug Safety......................... ....28
2.2.3 Drug Formulation Development.......*............. 29
2.3 Clinical Development...................................... 30
2.3.1 Phase I Clinical Trials.......................... 30
2.3.2 Phase H/III Clinical Trials...........*............ 31
2*3.3 New Drug Application............................. 33
2.3.4 Accelerated Approval and Unique Clinical
Development Methods.............................. 34
2.3.5 Clinical Development Plan.......................... 35
2.3.6 Postmarketing Development.......................... 36
References.......................................................38
3 Regulatory Review Organizations................................. 39
3.1 Food and Drug Administration............................ 39
3.1.1 Drugs..............................—.................41
3.1.2 Biologies...*.*............-.......~.................41
3.1.3 Dev ices......................................... 43
ini
viii Contents
3.1.4 FDA-Industry Interactions.............................45
3.1.4.1 Pre-IND Meeting............................. 46
3.1.4.2 End of Phase II Meeting.......................46
3.1.4.3 Pre-NDA/BLA Meeting...........................47
3.1.4.4 Advisory Committee Meetings................. 48
3.2 European Medicines Agency....................................* 51
3.3 Guidances....................................................54
References.........................................................56
4 Clinical Trial Statisticians.......................................57
4.1 Roles of the Clinical Trial Statistician.....................57
4.2 Important Attributes and Suggestions for Development.........60
4.2.1 Improve Communication Skills (Writing, Listening,
Speaking, and Presenting).............................61
4.2.2 Keep Learning (Statistics and Medicine)...............62
4.2.3 Know the Medical Literature...........................62
4.2.4 Think First (before Researching) and Keep Thinking....62
4.2.5 Educate Colleagues regarding Fundamental
Statistical Concepts..................................62
4.2.6 Identify Options and Their Pros and Cons..............63
4.2.7 Be Proactive........................................63
4.2.8 Become Detectiv e Sherlock Holmes.....................63
4.2.9 Avoid Being Isolated..................................63
4.2.10 Ask Lots of Questions; Question the Question..........63
4.2.11 Voice Scientific Opinions........................... 64
4.2.12 Protect Scientific Integrity........................ 64
4.2.13 Use Your References and Resources.....................64
4.2.14 Identify Mentors......................................65
4.2.15 Learn from Your Mistakes................... .........65
4.2.16 Do Not Rush with Answers.......................... 65
4.2.17 Be Open-Minded and Compassionate; Practice
Humility and Professionalism..........................65
4.2.18 Finish the Job.................................... 66
4.2.19 Participate in Professional Societies, Attend
Professional Meetings, and Take Short Courses.........66
References................................................. 67
Section II Scientific and Practical Issues
5 General Considerations in Clinical Trial Design...................... 71
5.1 General Design Issues in Clinical Trials.....................71
5.1.1 What Is the Question?........................... 71
5.1.2 Design Efficiency and Robustness.................... 72
5.1.3 Selection of a Population and Entry Criteria........ 73
5.1.4 Selection of Endpoints............................... 75
5.1.4.1 Desirable Characteristics of Endpoints......75
5.1.4.2 Scales of Measurement..................... 76
5.1.4.3 Objective vs. Subjective Endpoints..........77
5.1.4.4 Composite Endpoints..................... 77
5.1.4.5 Multiple Endpoints..........................79
5.1.4.6 Surrogate Endpoints....................... 80
5.1.5 Controlled vs. Uncontrolled Single-Arm Trials........82
5.1.6 Sample Size..........................................83
5.1.6.1 Hypothesis Testing versus Precision....... 83
5.1.6.2 Choosing an Acceptable Type I Rate..........83
5.1.6.3 Choosing an Acceptable Type II Error Rate.84
5.1.6.4 Choosing the Minimum Clinically
Important Difference...................... 84
5.1.6*5 Estimating Variability.................... 85
5.1.6.6 Group Sequential and Adaptive Designs.......85
5.1.6.7 Other Issues to Be Considered during
Sample Size Calculation.....................86
5.1.6.8 Simulations........................... 88
5.1.6.9 Sensitivity Analyses.................... 88
5.1.7 Data Management Considerations.......................88
5.1.7.1 Case Report Form Development.............. 89
5.1.8 The Prevention of Missing Data................... 90
Design Issues in Controlled Clinical Trials............... 93
5.2.1 Randomization.................................... 93
5.2.1.1 Stratification..............................93
5.2.1.2 Block Randomization....................... 93
5.2.1.3 Adaptive Randomization.................... 95
5.2.1.4 Interactive Voice Recognition System ... 96
5.2.1.5 Cluster Randomization................... 97
5.2.2 Blinding/Masking.................................. -98
5.2.2.1 Selection of a Control Group............. 100
5.2.2J2 Placebos/Shams........................ 100
5.2.2.3 Active Controls...........................-103
3.2.2.4 Historical Controls...................... 104
5.2.3 Parallel Group vs. Crossover Designs ............. 105
5.2.3.1 Parallel Group Designs................... 105
5.2.3.2 Crossover Designs..........................106
Special Issues.........................*....*...*.........HO
5.3.1 Design Issues in Biologies........—................HO
5.3.1.1 Immunogen icily Studies, Field Studies,
Lot Consistency Studies...................- H2
5.3.2 Design Issues in Devices....... .................—* H3
5.3.3 Multicenter Trials................*......-.....*...H4
5.3.3.1 Multiregional Trials..................... 114
X
Contents
5.3.4 Design Issues in Rare Diseases........................115
5.3.5 Bayesian Designs......................................116
References.........................................................118
6 Clinical Trial Designs.............................................121
6.1 Phase I......................................................121
6.1.1 PK/PD Designs....................................... 122
6.1.2 Bioavailability/Bioequivalence........................123
6.1.3 Estimation of MTD.....................................125
6.2 Other Trial Designs Including Phase II and III...............126
6.2.1 Proof of Concept Study............................ 126
6.2.2 Dose-Finding Study Designs.......................... 127
6.2.2.1 Frequency of Dosing........................ 128
6.2.2.2 Fixed Dose versus Dose Titration Designs.....129
6.2.2.3 Range of Doses to Be Studied.................130
6.2.2.4 Number of Doses............................ 130
6.2.2.5 Dose Allocation and Dose Spacing.............131
6.2.2.6 Adaptive Dose-Finding........................132
6.2.3 Noninferiority Trials ................................132
6.2.3.1 Examples........,............................133
6.2.3.2 Design Issues ........................... 135
6.2.3.3 Clarification of the Two Distinct Objectives.140
6.2.3.4 Analyses............................... 141
6.2.3.5 Missing Data........................... 141
6.2.3.6 Switching between N1 and Superiority.........142
6.2.4 Futility Designs.................................... 143
6.2.5 Factorial Designs.....................................144
6.2.5.1 The 2x2 Factorial Design.....................144
6.2.5.2 The No Interaction Assumption............ 145
6.2.5.3 Sample Size.............................. 146
6.2.6 Factorial Designs with More than Two Factors
and Assessment of More than One Outcome.............. 146
6.2.6.1 Interim Monitoring...........................147
6.2.6.2 Recruitment and Adherence....................147
6.2.6.3 Analyses and Reporting................... 147
6.2.7 Biomarker Designs................................. 148
6.2.8 Adaptive Designs................................ 151
6.2.8.1 Two-Stage Designs.......................... 153
6.2.B.2 Changing Endpoints.......................... 156
6.2.8.3 Sample Size Recalculation....................160
6.2.9 Dynamic Treatment Regimes........................... 161
6.2.10 Diagnostic Device Trials........................ 164
6.2.10.1 Example.................................. 166
6.3 Phase IV...................................................... 169
References.........................................................171
Contents xi
7 Interim Data Monitoring...............*........................175
7.1 Data Monitoring Committees/Data Safety Monitoring Boards.... 175
7.1.1 Membership................................... 176
7.1.2 When Are DMCs Needed?............................ 177
7.1.3 Roles..............................................177
7.1.4 Organization................................. 179
7.1.5 Charter.................................... .......181
7.1.6 Data Monitoring Plan...............................182
7.1.7 Meetings....................................... 182
7.1.8 Reports...................................... 183
7.1.9 Recommendations............................ 186
7.1.10 DMCs of the Future.................................187
7.2 Interim Monitoring Methods................................189
7.2.1 Evaluating Efficacy............................ 189
7.2.2 Evaluating Futility................................190
7.3 Limitations and Extensions................................191
7.3.1 Predicted Intervals................................192
7.3.1.1 Binary Endpoints......................... 192
7.3.1.2 Continuous Endpoints.......................193
7.3.1.3 Time-to-Event Endpoints.................. 193
7.3.1*4 Example: NARC 009........................ 194
7.3.2 Predicted Interval Plots..................... 195
7.3.2.1 Example....................................195
7.3.2.2 The Utility of Pis....................... 197
7.4 A Centralized Risk-Based Approach to Monitoring......... 198
References.....................................................198
8 Analysis Considerations....................................... 201
8.1 SAP.......................................................201
8.2 Other Preparations for Analyses...........................204
8.2.1 Data Management Preparations for Analyses..........204
8.2.2 Clinical Data Interchange Standards Consortium ....204
8.2.3 Statistical Programming........................ 204
8.3 General Issues............................................206
8.3.1 Describe the Data.............................. 206
8.3.2 Analysis Sets (ITT versus Per Protocol [PP]).......206
8.3.2.1 The ITT Principle..........................207
8.3.2.2 Intent-to-Diagnose..................... 212
8.3.3 Baseline Comparisons and Baseline as a Covariate...212
8.3.4 p-Values versus Confidence Intervals............. 215
83.4.1 Poor p-Value Interpretation................215
8.3.43 Need for CIs......................... 216
8.3.5 Time Windows, Visit Windows.................. 217
8.3.6 Multiplicity ................................ 218
8.3.7 Confounding * Effect Modification.............. 222
xii Contents
8.3.8 Stratification.....................................223
8.3.9 Subgroup Analyses..................................* 224
8.3.9.1 Subpopulation Treatment Effect Pattern Plot... 226
8.3.10 Multicenter Trials.................................226
8.3.11 Multinational Trials........................... 228
8.3.12 Missing Data................................. 230
8.3.12.1 Preliminary Analyses for Missing Data.....230
8.3.12.2 Definitions...............................231
8.3.12.3 Analyses Methodologies for Missing Data...232
8.3.13 Competing Risks....................................235
8.3.14 Censoring in Survival Data....................... 237
8.3.14.1 Design and Monitoring.....................237
8.3.14.2 Preliminary Investigation.................238
8.3.14.3 Sensitivity Analyses......................238
8.3.14.4 Extreme Sensitivity Analyses..............239
8.3.15 Adherence........................................ 239
8.3.16 Rescue Medications............................... 241
8.3.17 Treatment Crossover.............................. 243
8.3.18 Association ^ Causation.......................... 245
8.3.19 Causation Determination............................245
8.3.20 Diagnostic Trials................................ 246
8.3.20.1 ITD and the Impact of Interpretable Tests.249
8.3.20.2 Example...................................250
8.4 Report Writing........................................ 251
8.4.1 Balanced Interpretation........................ 254
8.4.2 Drug Trials in a Regulatory Setting................254
References.................................................. 257
9 Analysis of Safety, Benefit:Risk, and Quality of Life...........261
9.1 Safety.................................................. 261
9.1.1 Adverse Events............................... 263
9.1.1.1 Definitions...............................263
9.1.1.2 Coding.............................. 264
9.1.1.3 Spontaneous versus Active Collection......265
9.1.1.4 Targeted AEs................... .........266
9.1.1.5 Analysis Issues....................... 266
9.1.2 Laboratory and Vital Sign Data................... 270
9.1.2.1 Analysis Issues...........................270
9.1.3 Safety Analyses Using Observational Data......... 272
9.2 BenefitrRisk Evaluation...................................274
9.2.1 Challenges..................................... 274
9.2.2 Measurement.................................. 274
9.2.3 Summarization.................................. 276
9.2.4 Assessment................................. 277
9.2.5 Combining Separate Marginal Analyses............. 278
Contents
xiii
9.2.5.1 One Dimension: WithinTntervention
Measures.............................. 278
9.2.5.2 One Dimension: Comparative Measures...... 279
9.2.5.3 Multidimensional Approaches...............282
9.2.6 Within-Patient Analyses...........................284
9.2.6.1 Linear Combinations.......................285
9.2.6.2 Composite Event-Time Endpoints............286
9.2.6.3 Ordinal Data..............................286
9.2.6.4 Scatterplot Methods for Continuous Data.... 287
9.2.6.5 Adjudication Committee (AC) Approach......289
9.2.7 Tailored Medicine............................... 289
9.3 Quality of Life..........................................291
9.3.1 QoL Instruments............................... 292
9.3.2 Issues in Design and Analyses................... 293
9.3.3 Patient Preferences...............................294
References................................................. 296
10 Publishing Trial Results.......................................301
10.1 Guidelines for Reporting Clinical Trial Results...........304
10.1.1 The CONSORT Statement.............................304
10.1.2 Reporting of Harms Data...........................304
10.1.3 The TREND Statement...............................309
10.1.4 The STARD Statement........................... 309
10.2 Reporting the Results of Subgroup Analyses ................ 312
10.3 Reporting Benefits and Risks.......................... 314
10.4 Reporting N1 Trials......................................317
10.5 Reporting Adaptive Designs............................. 317
10.6 Reporting Bayesian Designs............................ 317
References.................................................*...319
Appendix: Excerpts from the Lipitor® Drug Label.................... 321
Index........................................................ 329
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| indexdate | 2024-07-09T23:24:45Z |
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| isbn | 9781420090871 1420090879 |
| language | English |
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| record_format | marc |
| series2 | Chapmann & Hall/CRC biostatistics series |
| spelling | Evans, Scott Verfasser aut Fundamental concepts for new clinical trialists Scott Evans ; Naitee Ting Boca Raton, FL [u.a.] CRC Press 2016 XIX, 348 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Chapmann & Hall/CRC biostatistics series Konzeption (DE-588)4204973-8 gnd rswk-swf Klinisches Experiment (DE-588)4164223-5 gnd rswk-swf Klinisches Experiment (DE-588)4164223-5 s Konzeption (DE-588)4204973-8 s DE-604 Ting, Naitee Verfasser aut Digitalisierung UB Regensburg - ADAM Catalogue Enrichment application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=022617450&sequence=000003&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Klappentext Digitalisierung UB Regensburg - ADAM Catalogue Enrichment application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=022617450&sequence=000004&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Evans, Scott Ting, Naitee Fundamental concepts for new clinical trialists Konzeption (DE-588)4204973-8 gnd Klinisches Experiment (DE-588)4164223-5 gnd |
| subject_GND | (DE-588)4204973-8 (DE-588)4164223-5 |
| title | Fundamental concepts for new clinical trialists |
| title_auth | Fundamental concepts for new clinical trialists |
| title_exact_search | Fundamental concepts for new clinical trialists |
| title_full | Fundamental concepts for new clinical trialists Scott Evans ; Naitee Ting |
| title_fullStr | Fundamental concepts for new clinical trialists Scott Evans ; Naitee Ting |
| title_full_unstemmed | Fundamental concepts for new clinical trialists Scott Evans ; Naitee Ting |
| title_short | Fundamental concepts for new clinical trialists |
| title_sort | fundamental concepts for new clinical trialists |
| topic | Konzeption (DE-588)4204973-8 gnd Klinisches Experiment (DE-588)4164223-5 gnd |
| topic_facet | Konzeption Klinisches Experiment |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=022617450&sequence=000003&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=022617450&sequence=000004&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA |
| work_keys_str_mv | AT evansscott fundamentalconceptsfornewclinicaltrialists AT tingnaitee fundamentalconceptsfornewclinicaltrialists |