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Cover
Copyright
Title Page
Dedication
Contents
Foreword
Acknowledgments
INTRODUCTION
CHAPTER 1. From “Nonentity” to Global Network
The Rise of a New Style of Biomedical Practice
An Early Career in Clinical Oncology
About This Book
A Capsule History of Cancer Clinical Trials
Cancer Clinical Trials as a New Style of Practice
The Protocol
Conclusion
PRELUDE. Before There Were Trials
Cancer Hospitals and Cancer Institutes
Diagnosing Cancer
Treating Cancer
Prognosticating Cancer
Testing Therapies
Conclusion
PART 1. The Emergence of Clinical Cancer Research (1955–66)
CHAPTER 2. A Landmark Clinical Trial
Curing Leukemia: The VAMP Trial
A Collective Undertaking
The Elements of Innovation
What about the Patients?
CHAPTER 3. The Collective Turn: Cooperative Groups as Epistemic Organizations
Assembling the US Cooperative System
Screening for Drugs: From Mice to Humans
Tinkering with the Cooperative Group Structure
Meanwhile in Europe …
Conclusion
FIRST INTERLUDE. Clinical Trial Statistics
What Is a Random Sample?
What Is Statistical Significance?
CHAPTER 4. Statisticians, Statistics, and Early Cooperative Clinical Trials
Statisticians at the NIH
Statisticians in Paris
Fabricating the Tools of the Trade
Controversial Methods
The Emergence of the Phase System
Conclusion
CHAPTER 5. Criticism and the Redefinition of Clinical Cancer Trials as an Autonomous Form of Research
Clinical Cancer Research under Fire
The Reorganization of Screening and Clinical Trials in the United States
Surgery and Radiotherapy in the Cooperative Groups
PART 2. An Avalanche of Numbers from the New Style of Practice (1965–89)
CHAPTER 6. A Web of Trials
Breast Cancer and Its Trials
The Lessons of the Breast Cancer Trials
The Emergence of Combination Chemotherapy
The Multiple Meanings of Breast Cancer Trials
Conclusion
CHAPTER 7. Statisticians, Data Centers, and the Organization of Large-Scale Clinical Trials
Centers of Calculation: US Statisticians and the Data Center
The Mechanics of Data Production
Meanwhile in Europe, Take Two
Back in the USA: Group Statisticians and NCI Statisticians
Insiders’ Dissent: The Randomization Debate
CHAPTER 8. A Relational Space of Substances and Regimens
The Clinical Evaluation of Substances
Screening Substances: The Animal Screen
Procuring Compounds
CHAPTER 9. Oncopolitics? Reshaping Collaborative Research
Centralization or Coordination? The European Debate
Clinical Trials as Clinical Research: The US Debate
Oncology in the Community
PART 3. Targeted Therapy, Targeted Trials (1990–2006)
SECOND INTERLUDE. Molecular Biology and Oncogenes
Introduction
The Rise of Molecular Biology
Cancer and Molecular Biology: 1960–80
The Clinical Isolation of Human Oncogenes
Oncogenes and Oncoproteins since 1982
CHAPTER 10. Magic Bullets? The Gleevec Trials
Molecular Biology and Targeted Substances
The Trials of a Targeted Therapy
Where Did Gleevec Come From?
Monitoring Data, Managing Risks
A Medical Oncologist and His Patients
Patients and Activists
Conclusion
CHAPTER 11. Targeted Therapy and Clinical Cancer Research
Introduction: Molecular Biology and Translational Research
Molecular Biology and the US Cooperative Groups
The Reorganization of the Drug Discovery Process and the Transformation of the NCI Screen
Clinical Trials in a Targeted Age
More Oncopolitics
Conclusion
CONCLUSION
CHAPTER 12. Looking Back and Looking Forward
The Observational Alternative to Clinical Cancer Trials
Comparative Effectiveness and Clinical Trials
Coda
Notes
References
Index
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