A Practical Guide to Designing Phase II Trials in Oncology.

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...

Descripción completa

Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Brown, Sarah R.
Otros Autores: Gregory, Walter M., Twelves, Christopher J., Buyse, Marc E., Parmar, Mahesh K., Seymour, Matthew T., Brown, Julia M.
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Hoboken : Wiley, 2014.
©2014
Colección:Statistics in practice.
Temas:
Antineoplastic agents.
Antimitotic agents.
Clinical Trials, Phase II as Topic
Antineoplastic Agents > therapeutic use
Drug Evaluation > methods
Neoplasms > drug therapy
Clinical Trials, Phase II
Antineoplastic Agents
Antimitotic Agents
Anticancéreux.
HEALTH & FITNESS > Diseases > General.
MEDICAL > Clinical Medicine.
MEDICAL > Diseases.
MEDICAL > Evidence-Based Medicine.
MEDICAL > Internal Medicine.
Antimitotic agents
Antineoplastic agents
Acceso en línea:Texto completo
Tabla de Contenidos:
  • 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.

Ejemplares similares