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El. knyga: Practical Guide to Designing Phase II Trials in Oncology

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  • Formatas: EPUB+DRM
  • Serija: Statistics in Practice
  • Išleidimo metai: 28-Mar-2014
  • Leidėjas: John Wiley & Sons Inc
  • Kalba: eng
  • ISBN-13: 9781118763636
Kitos knygos pagal šią temą:
Practical Guide to Designing Phase II Trials in OncologyDidesnis paveikslėlis
  • Formatas: EPUB+DRM
  • Serija: Statistics in Practice
  • Išleidimo metai: 28-Mar-2014
  • Leidėjas: John Wiley & Sons Inc
  • Kalba: eng
  • ISBN-13: 9781118763636
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"Choosing Your Phase II Trial Design provides an overview to clinical trial researchers of the steps involved in designing a phase II trial and provides a way to identify a range of optimal designs. Providing a practical guide containing the information needed to make crucial decisions regarding phase II trial designs, it sets forth specific points for consideration between the statistician and clinician when designing a phase II trial, including issues such as how the treatment works, choice of outcome measure and randomisation. A detailed library of trial designs is featured along with examples and case studies accompanied by illustrations using a flow diagram, highlighting the choices made for each key point throughout the process. For those new to trial design, the book provides an introduction to the concepts behind informed decision making in phase II trials, offering a unique and practical learning tool. For those familiar with phase II trial design, the reader will benefit from exposure to new, less familiar trial designs, providing alternative options to those which the reader may not have previously used"--Provided by publisher.



A comprehensive and practical overview of the identification, conduct and analysis of optimal Phase II trial design.

Choosing Your Phase II Trial Design demonstrates how to approach trial design when there are various options available, such as multiple possible outcome measures, and to use the key characteristics provided to make an informed decision regarding which specific trial design to choose. It sets forth specific points for consideration between the statistician and clinician when designing a phase II trial, including issues such as how the treatment works, choice of outcome measure and randomization. Real life examples and case studies featured throughout the book are accompanied by illustrations using a flow diagram, highlighting the choices made for each key point throughout the process.

Choosing Your Phase II Trial Design provides an introduction to key concepts for beginners and explores lesser known and alternative approaches to trial design for the more experienced researcher.

Contributors xv
Foreword I xvii
Elizabeth A. Eisenhauer
Foreword II xix
Roger A'Hern
Preface xxi
1 Introduction 1(11)
Sarah Brown
Julia Brown
Walter Gregory
Chris Twelves
1.1 The role of phase II trials in cancer
3(2)
1.2 The importance of appropriate phase II trial design
5(1)
1.3 Current use of phase II designs
6(1)
1.4 Identifying appropriate phase II trial designs
7(2)
1.5 Potential trial designs
9(1)
1.6 Using the guidance to design your trial
10(2)
2 Key points for consideration 12(24)
Sarah Brown
Julia Brown
Marc Buyse
Walter Gregory
Mahesh Parmar
Chris Twelves
2.1 Stage 1 Trial questions
14(4)
2.1.1 Therapeutic considerations
14(2)
2.1.2 Primary intention of trial
16(1)
2.1.3 Number of experimental treatment arms
17(1)
2.1.4 Primary outcome of interest
18(1)
2.2 Stage 2 Design components
18(15)
2.2.1 Outcome measure and distribution
18(3)
2.2.2 Randomisation
21(5)
2.2.3 Design category
26(7)
2.3 Stage 3 Practicalities
33(2)
2.3.1 Practical considerations
33(2)
2.4 Summary
35(1)
3 Designs for single experimental therapies with a single arm 36(32)
Sarah Brown
3.1 One-stage designs
36(5)
3.1.1 Binary outcome measure
36(2)
3.1.2 Continuous outcome measure
38(1)
3.1.3 Multinomial outcome measure
39(1)
3.1.4 Time-to-event outcome measure
40(1)
3.1.5 Ratio of times to progression
40(1)
3.2 Two-stage designs
41(14)
3.2.1 Binary outcome measure
41(9)
3.2.2 Continuous outcome measure
50(1)
3.2.3 Multinomial outcome measure
50(3)
3.2.4 Time-to-event outcome measure
53(1)
3.2.5 Ratio of times to progression
54(1)
3.3 Multi-stage designs
55(5)
3.3.1 Binary outcome measure
55(4)
3.3.2 Continuous outcome measure
59(1)
3.3.3 Multinomial outcome measure
59(1)
3.3.4 Time-to-event outcome measure
60(1)
3.3.5 Ratio of times to progression
60(1)
3.4 Continuous monitoring designs
60(4)
3.4.1 Binary outcome measure
60(3)
3.4.2 Continuous outcome measure
63(1)
3.4.3 Multinomial outcome measure
63(1)
3.4.4 Time-to-event outcome measure
63(1)
3.4.5 Ratio of times to progression
64(1)
3.5 Decision-theoretic designs
64(1)
3.5.1 Binary outcome measure
64(1)
3.5.2 Continuous outcome measure
65(1)
3.5.3 Multinomial outcome measure
65(1)
3.5.4 Time-to-event outcome measure
65(1)
3.5.5 Ratio of times to progression
65(1)
3.6 Three-outcome designs
65(2)
3.6.1 Binary outcome measure
65(1)
3.6.2 Continuous outcome measure
66(1)
3.6.3 Multinomial outcome measure
66(1)
3.6.4 Time-to-event outcome measure
66(1)
3.6.5 Ratio of times to progression
67(1)
3.7 Phase HMI designs
67(1)
4 Designs for single experimental therapies including randomisation 68(15)
Sarah Brown
4.1 One-stage designs
68(4)
4.1.1 Binary outcome measure
68(2)
4.1.2 Continuous outcome measure
70(1)
4.1.3 Multinomial outcome measure
70(1)
4.1.4 Time-to-event outcome measure
70(2)
4.1.5 Ratio of times to progression
72(1)
4.2 Two-stage designs
72(3)
4.2.1 Binary outcome measure
72(1)
4.2.2 Continuous outcome measure
73(1)
4.2.3 Multinomial outcome measure
74(1)
4.2.4 Time-to-event outcome measure
75(1)
4.2.5 Ratio of times to progression
75(1)
4.3 Multi-stage designs
75(1)
4.3.1 Binary outcome measure
75(1)
4.3.2 Continuous outcome measure
75(1)
4.3.3 Multinomial outcome measure
75(1)
4.3.4 Time-to-event outcome measure
76(1)
4.3.5 Ratio of times to progression
76(1)
4.4 Continuous monitoring designs
76(1)
4.4.1 Binary outcome measure
76(1)
4.4.2 Continuous outcome measure
76(1)
4.4.3 Multinomial outcome measure
76(1)
4.4.4 Time-to-event outcome measure
76(1)
4.4.5 Ratio of times to progression
76(1)
4.5 Three-outcome designs
77(1)
4.5.1 Binary outcome measure
77(1)
4.5.2 Continuous outcome measure
77(1)
4.5.3 Multinomial outcome measure
77(1)
4.5.4 Time-to-event outcome measure
77(1)
4.5.5 Ratio of times to progression
77(1)
4.6 Phase II/III designs
77(5)
4.6.1 Binary outcome measure
77(2)
4.6.2 Continuous outcome measure
79(1)
4.6.3 Multinomial outcome measure
80(1)
4.6.4 Time-to-event outcome measure
81(1)
4.6.5 Ratio of times to progression
81(1)
4.7 Randomised discontinuation designs
82(2)
4.7.1 Binary outcome measure
82(1)
4.7.2 Continuous outcome measure
82(1)
4.7.3 Multinomial outcome measure
82(1)
4.7.4 Time-to-event outcome measure
82(1)
4.7.5 Ratio of times to progression
82(1)
5 Treatment selection designs 83(29)
Sarah Brown
5.1 Including a control arm
84(19)
5.1.1 One-stage designs
84(1)
5.1.2 Two-stage designs
84(4)
5.1.3 Multi-stage designs
88(1)
5.1.4 Continuous monitoring designs
89(1)
5.1.5 Decision-theoretic designs
89(1)
5.1.6 Three-outcome designs
89(1)
5.1.7 Phase designs — same primary outcome measure at phase II and phase III
89(10)
5.1.8 Phase II/III designs — different primary outcome measures at phase II and phase III
99(3)
5.1.9 Randomised discontinuation designs
102(1)
5.2 Not including a control arm
103(9)
5.2.1 One-stage designs
103(3)
5.2.2 Two-stage designs
106(2)
5.2.3 Multi-stage designs
108(1)
5.2.4 Continuous monitoring designs
109(1)
5.2.5 Decision-theoretic designs
110(1)
5.2.6 Three-outcome designs
110(1)
5.2.7 Phase II/III designs — same primary outcome measure at phase II and phase III
110(1)
5.2.8 Randomised discontinuation designs
111(1)
6 Designs incorporating toxicity as a primary outcome 112(19)
Sarah Brown
6.1 Including a control arm
112(5)
6.1.1 One-stage designs
112(2)
6.1.2 Two-stage designs
114(1)
6.1.3 Multi-stage designs
115(2)
6.2 Not including a control arm
117(9)
6.2.1 One-stage designs
117(1)
6.2.2 Two-stage designs
118(4)
6.2.3 Multi-stage designs
122(3)
6.2.4 Continuous monitoring designs
125(1)
6.3 Toxicity alone
126(2)
6.3.1 One stage
126(1)
6.3.2 Continuous monitoring
127(1)
6.4 Treatment selection based on activity and toxicity
128(3)
6.4.1 Two-stage designs
128(1)
6.4.2 Multi-stage designs
129(1)
6.4.3 Continuous monitoring designs
129(2)
7 Designs evaluating targeted subgroups 131(10)
Sarah Brown
7.1 One-stage designs
131(1)
7.1.1 Binary outcome measure
131(1)
7.2 Two-stage designs
132(3)
7.2.1 Binary outcome measure
132(3)
7.3 Multi-stage designs
135(3)
7.3.1 Binary outcome measure
135(2)
7.3.2 Time-to-event outcome measure
137(1)
7.4 Continuous monitoring designs
138(3)
7.4.1 Binary outcome measure
138(1)
7.4.2 Time-to-event outcome measure
139(2)
8 'Chemo-radio-sensitisation' in head and neck cancer 141(10)
John Chester
Sarah Brown
Stage 1 Trial questions
141(1)
Therapeutic considerations
141(1)
Primary intention of trial
142(1)
Number of experimental treatment arms
142(1)
Primary outcome of interest
142(1)
Stage 2 Design components
142(4)
Outcome measure and distribution
142(1)
Randomisation
143(1)
Design category
143(1)
Possible designs
144(2)
Stage 3 Practicalities
146(2)
Practical considerations for selecting between designs
146(2)
Proposed trial design
148(2)
Summary
150(1)
9 Combination chemotherapy in second-line treatment of non-small cell lung cancer 151(12)
Ornella Belvedere
Sarah Brown
Stage 1 Trial questions
152(1)
Therapeutic considerations
152(1)
Primary intention of trial
152(1)
Number of experimental treatment arms
152(1)
Primary outcome of interest
152(1)
Stage 2 Design components
153(2)
Outcome measure and distribution
153(1)
Randomisation
153(1)
Design category
153(1)
Possible designs
154(1)
Stage 3 Practicalities
155(3)
Practical considerations for selecting between designs
155(3)
Proposed trial design
158(4)
Summary
162(1)
10 Selection by biomarker in prostate cancer 163(11)
Rick Kaplan
Sarah Brown
Stage 1 Trial questions
164(1)
Therapeutic considerations
164(1)
Primary intention of trial
164(1)
Number of experimental treatment arms
164(1)
Primary outcome of interest
164(1)
Stage 2 Design components
165(3)
Outcome measure and distribution
165(1)
Randomisation
165(1)
Design category
166(1)
Possible designs
167(1)
Stage 3 Practicalities
168(2)
Practical considerations for selecting between designs
168(2)
Proposed trial design
170(1)
Summary
171(3)
11 Dose selection in advanced multiple myeloma 174(11)
Sarah Brown
Steve Schey
Stage 1 Trial questions
174(2)
Therapeutic considerations
174(1)
Primary intention of trial
175(1)
Number of experimental arms
175(1)
Primary outcome of interest
175(1)
Stage 2 Design components
176(2)
Outcome measure and distribution
176(1)
Randomisation
176(1)
Design category
177(1)
Possible designs
177(1)
Stage 3 Practicalities
178(3)
Practical considerations for selecting between designs
178(3)
Proposed trial design
181(1)
Summary
182(3)
12 Targeted therapy for advanced colorectal cancer 185(10)
Matthew Seymour
Sarah Brown
Stage 1 Trial questions
185(2)
Therapeutic considerations
185(1)
Primary intention of trial
186(1)
Number of experimental treatment arms
186(1)
Primary outcome of interest
186(1)
Stage 2 Design components
187(3)
Outcome measure and distribution
187(1)
Randomisation
187(1)
Design category
188(1)
Possible designs
189(1)
Stage 3 Practicalities
190(1)
Practical considerations for selecting between designs
190(1)
Proposed trial design
191(3)
Summary
194(1)
13 Phase II oncology trials: Perspective from industry 195(18)
Anthony Rossini
Steven Green
William Mietlowski
13.1 Introduction
195(1)
13.2 Commercial challenges, drivers and considerations
196(1)
13.3 Selecting designs by strategy
197(13)
13.3.1 Basic strategies addressed by phase II studies
198(1)
13.3.2 Potential registration
198(5)
13.3.3 Exploratory activity
203(1)
13.3.4 Regimen selection
204(2)
13.3.5 Phase II to support predicting success in phase III
206(2)
13.3.6 Phase II safety trials
208(1)
13.3.7 Prospective identification of target populations
209(1)
13.4 Discussion
210(3)
References 213(14)
Index 227
Sarah Rose Brown, Walter M. Gregory, Christopher J. Twelves, and Julia M. Brown, Clinical Trials Research Unit, University of Leeds, UK
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