Oncology clinical trials /

Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Otros Autores: Kelly, Wm. Kevin (William Kevin), Halabi, Susan
Formato: Electrónico eBook
Idioma:Inglés
Publicado: New York : Demos Medical, ©2010.
Temas:
Cancer > Research > Statistical methods.
Clinical trials.
Neoplasms > drug therapy
Clinical Trials as Topic
Cancer > Recherche > Méthodes statistiques.
Études cliniques.
HEALTH & FITNESS > Diseases > Cancer.
Electronic books.
Electronic book.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Foreword; Preface; Contributors; 1. Introduction: What Is a Clinical Trial?; 2. Historical Perspectives of Oncology Clinical Trials; 3. Ethical Principles Guiding Clinical Research; 4. Preclinical Drug Assessment; 5. Formulating the Question and Objectives; 6. Choice of Endpoints in Cancer Clinical Trials; 7. Design, Testing, and Estimation in Clinical Trials; 8. Design of Phase I Trials; 9. Design of Phase II Trials; 10. Randomization; 11. Design of Phase III Trials; 12. Multiple Treatment Arm Trials; 13. Noninferiority Trials in Oncology; 14. Bayesian Designs in Clinical Trials
  • 15. The Trials and Tribulations of Writing an Investigator Initiated Clinical Study16. Data Collection; 17. Reporting of Adverse Event; 18. Toxicity Monitoring: Why, What, When?; 19. Interim Analysis of Phase III Trials; 20. Interpretation of Results: Data Analysis and Reporting of Results; 21. Statistical Considerations for Assessing Prognostic Factors in Cancer; 22. Pitfalls in Oncology Clinical Trial Designs and Analysis; 23. Biomarkers and Surrogate Endpoints in Clinical Trials; 24. Use of Genomics in Therapeutic Clinical Trials; 25. Imaging in Clinical Trials
  • 26. Pharmacokinetic and Pharmacodynamic Monitoring in Clinical Trials: When Is It Needed?27. Practical Design and Analysis Issues of Health Related Quality of Life Studies in International Randomized Controlled Cancer Clinical Trials; 28. Clinical Trials Considerations in Special Populations; 29. A Critical Reader's Guide to Cost-Effectiveness Analysis; 30. Systemic Review and Meta-Analysis; 31. Regulatory Affairs: The Investigator-Initiated Oncology Trial; 32. The Drug Evaluation Process in Oncology: FDA Perspective; 33. Industry Collaboration in Cancer Clinical Trials
  • 34. Defining the Roles and Responsibilities of Study Personnel35. Writing a Consent Form; 36. How Cooperative Groups Function; 37. Adaptive Clinical Trial Design in Oncology; 38. Where Do We Need to Go with Clinical Trials in Oncology?; Index

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