A practical guide to designing phase II trials in oncology / [edited by] Sarah R. Brown, Walter M.

Format:

Book

Contributor:

Brown, Sarah, editor.

Gregory, Walter M., editor.

Twelves, Chris, editor.

Series:

Statistics in practice.

Statistics in Practice

Language:

English

Subjects (All):

Antineoplastic agents.

Physical Description:

1 online resource (258 p.)

Edition:

1st ed.

Place of Publication:

Chichester, West Sussex, United Kingdom : John Wiley & Sons, 2014.

Language Note:

English

Summary:

"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.

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

4.4.5 Ratio of times to progression

Notes:

Description based upon print version of record.

Includes bibliographical references and index.

Description based on print version record.

ISBN:

9781118763636

1118763637

9781118763612

1118763610

9781118763629

1118763629

OCLC:

861966489