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 new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial resources and challenges the validity of the ethical contract between investigators and the volunteers who willingly give their time and effort to benefit future patients. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, Oncology Clinical Trials, provides a comprehensive guide for both early-career and senior oncology investigators into the successful design, conduct and analysis of an oncology clinical trial. Oncology Clinical Trials covers how to formulate a study question, selecting a study population, study design of Phase I, II, and III trials, toxicity monitoring, data analysis and reporting, use of genomics, cost-effectiveness analysis, systemic review and meta-analysis, and many other issues. Many examples of real-life flaws in clinical trials that have been reported in the literature are included throughout. The book discusses clinical trials from start to finish focusing on real-life examples in the development, design and analysis of clinical trials.Oncology Clinical Trials features: A systematic guide to all aspects of the design, conduct, analysis, and reporting of clinical trials in oncology Contributions from oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives Hot topics in oncology trials including multi-arm trials, meta-analysis and adaptive design, use of genomics, and cost-effectiveness analysis Real-life examples from reported clinical trials included throughout
Author(s): Kevin Kelly, Susan Halabi
Edition: 1
Year: 2009
Language: English
Pages: 450
Contents......Page 6
Foreword......Page 10
Preface......Page 12
Contributors......Page 14
1. Introduction: What Is a Clinical Trial?......Page 20
2. Historical Perspectives of Oncology Clinical Trials......Page 24
3. Ethical Principles Guiding Clinical Research......Page 30
4. Preclinical Drug Assessment......Page 40
5. Formulating the Question and Objectives......Page 48
6. Choice of Endpoints in Cancer Clinical Trials......Page 54
7. Design, Testing, and Estimation in Clinical Trials......Page 62
8. Design of Phase I Trials......Page 76
9. Design of Phase II Trials......Page 84
10. Randomization......Page 92
11. Design of Phase III Trials......Page 102
12. Multiple Treatment Arm Trials......Page 112
13. Noninferiority Trials in Oncology......Page 120
14. Bayesian Designs in Clinical Trials......Page 128
15. The Trials and Tribulations of Writing an Investigator Initiated Clinical Study......Page 138
16. Data Collection......Page 150
17. Reporting of Adverse Event......Page 160
18. Toxicity Monitoring: Why, What, When?......Page 170
19. Interim Analysis of Phase III Trials......Page 182
20. Interpretation of Results: Data Analysis and Reporting of Results......Page 198
21. Statistical Considerations for Assessing Prognostic Factors in Cancer......Page 208
22. Pitfalls in Oncology Clinical Trial Designs and Analysis......Page 216
23. Biomarkers and Surrogate Endpoints in Clinical Trials......Page 234
24. Use of Genomics in Therapeutic Clinical Trials......Page 246
25. Imaging in Clinical Trials......Page 258
26. Pharmacokinetic and Pharmacodynamic Monitoring in Clinical Trials: When Is It Needed?......Page 270
27. Practical Design and Analysis Issues of Health Related Quality of Life Studies in International Randomized Controlled Cancer Clinical Trials......Page 280
28. Clinical Trials Considerations in Special Populations......Page 286
29. A Critical Reader’s Guide to Cost-Effectiveness Analysis......Page 296
30. Systemic Review and Meta-Analysis......Page 304
31. Regulatory Affairs: The Investigator-Initiated Oncology Trial......Page 318
32. The Drug Evaluation Process in Oncology: FDA Perspective......Page 326
33. Industry Collaboration in Cancer Clinical Trials......Page 334
34. Defining the Roles and Responsibilities of Study Personnel......Page 340
35. Writing a Consent Form......Page 346
36. How Cooperative Groups Function......Page 354
37. Adaptive Clinical Trial Design in Oncology......Page 362
38. Where Do We Need to Go with Clinical Trials in Oncology?......Page 376
A......Page 382
C......Page 383
D......Page 385
E......Page 386
H......Page 387
I......Page 388
M......Page 389
N......Page 390
P......Page 391
R......Page 393
S......Page 394
U......Page 395
Z......Page 396
