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Title A Practical Guide to Designing Phase II Trials in Oncology.
Imprint Hoboken : Wiley, 2014.


 Internet  Electronic Book    AVAILABLE
Description 1 online resource (258 pages)
Series Statistics in Practice
Statistics in practice.
Note 4.4.5 Ratio of times to progression.
Bibliog. Includes bibliographical references and index.
Note Available only to authorized UTEP users.
Print version record.
Subject Antineoplastic agents.
Clinical Trials, Phase II as Topic.
Antineoplastic Agents -- therapeutic use.
Drug Evaluation -- methods.
Neoplasms -- drug therapy.
Clinical Trials, Phase II
Contents A Practical Guide to Designing Phase II Trials in Oncology; Contents; Contributors; Foreword I; Foreword II; Preface; 1 Introduction; 1.1 The role of phase II trials in cancer; 1.2 The importance of appropriate phase II trial design; 1.3 Current use of phase II designs; 1.4 Identifying appropriate phase II trial designs; 1.5 Potential trial designs; 1.6 Using the guidance to design your trial; 2 Key points for consideration; 2.1 Stage 1 -- Trial questions; 2.1.1 Therapeutic considerations; 2.1.2 Primary intention of trial; 2.1.3 Number of experimental treatment arms.
2.1.4 Primary outcome of interest2.2 Stage 2 -- Design components; 2.2.1 Outcome measure and distribution; 2.2.2 Randomisation; 2.2.3 Design category; 2.3 Stage 3 -- Practicalities; 2.3.1 Practical considerations; 2.4 Summary; 3 Designs for single experimental therapies with a single arm; 3.1 One-stage designs; 3.1.1 Binary outcome measure; 3.1.2 Continuous outcome measure; 3.1.3 Multinomial outcome measure; 3.1.4 Time-to-event outcome measure; 3.1.5 Ratio of times to progression; 3.2 Two-stage designs; 3.2.1 Binary outcome measure; 3.2.2 Continuous outcome measure.
3.2.3 Multinomial outcome measure3.2.4 Time-to-event outcome measure; 3.2.5 Ratio of times to progression; 3.3 Multi-stage designs; 3.3.1 Binary outcome measure; 3.3.2 Continuous outcome measure; 3.3.3 Multinomial outcome measure; 3.3.4 Time-to-event outcome measure; 3.3.5 Ratio of times to progression; 3.4 Continuous monitoring designs; 3.4.1 Binary outcome measure; 3.4.2 Continuous outcome measure; 3.4.3 Multinomial outcome measure; 3.4.4 Time-to-event outcome measure; 3.4.5 Ratio of times to progression; 3.5 Decision-theoretic designs; 3.5.1 Binary outcome measure.
3.5.2 Continuous outcome measure3.5.3 Multinomial outcome measure; 3.5.4 Time-to-event outcome measure; 3.5.5 Ratio of times to progression; 3.6 Three-outcome designs; 3.6.1 Binary outcome measure; 3.6.2 Continuous outcome measure; 3.6.3 Multinomial outcome measure; 3.6.4 Time-to-event outcome measure; 3.6.5 Ratio of times to progression; 3.7 Phase II/III designs; 4 Designs for single experimental therapies including randomisation; 4.1 One-stage designs; 4.1.1 Binary outcome measure; 4.1.2 Continuous outcome measure; 4.1.3 Multinomial outcome measure; 4.1.4 Time-to-event outcome measure.
4.1.5 Ratio of times to progression4.2 Two-stage designs; 4.2.1 Binary outcome measure; 4.2.2 Continuous outcome measure; 4.2.3 Multinomial outcome measure; 4.2.4 Time-to-event outcome measure; 4.2.5 Ratio of times to progression; 4.3 Multi-stage designs; 4.3.1 Binary outcome measure; 4.3.2 Continuous outcome measure; 4.3.3 Multinomial outcome measure; 4.3.4 Time-to-event outcome measure; 4.3.5 Ratio of times to progression; 4.4 Continuous monitoring designs; 4.4.1 Binary outcome measure; 4.4.2 Continuous outcome measure; 4.4.3 Multinomial outcome measure; 4.4.4 Time-to-event outcome measure.
Summary 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, cho.
Other Author Gregory, Walter M.
Twelves, Christopher J.
Buyse, Marc E.
Parmar, Mahesh K.
Seymour, Matthew T.
Brown, Julia M.
Other Title Print version: Brown, Sarah R. A Practical Guide to Designing Phase II Trials in Oncology. Hoboken : Wiley, ©2014 9781118570906