Clinical Trials: A Methodologic Perspective

Clinical Trials: A Methodologic Perspective
Contents
Preface to the Third Edition
About the Companion Website
1: Preliminaries
	1.1 Introduction
	1.2 Audiences
	1.3 Scope
	1.4 Other Sources of Knowledge
	1.5 Notation and Terminology
		1.5.1 Clinical Trial Terminology
		1.5.2 Drug Development Traditionally Recognizes Four Trial Design Types
		1.5.3 Descriptive Terminology Is Better
	1.6 Examples, Data, and Programs
	1.7 Summary
2: Clinical Trials as Research
	2.1 Introduction
	2.2 Research
		2.2.1 What Is Research?
		2.2.2 Clinical Reasoning Is Based on the Case History
		2.2.3 Statistical Reasoning Emphasizes Inference Based on Designed Data Production
		2.2.4 Clinical and Statistical Reasoning Converge in Research
	2.3 Defining Clinical Trials
		2.3.1 Mixing of Clinical and Statistical Reasoning Is Recent
		2.3.2 Clinical Trials Are Rigorously Defined
		2.3.3 Theory and Data
		2.3.4 Experiments Can Be Misunderstood
		2.3.5 Clinical Trials and the Frankenstein Myth
		2.3.6 Cavia porcellus
		2.3.7 Clinical Trials as Science
		2.3.8 Trials and Statistical Methods Fit Within a Spectrum of Clinical Research
	2.4 Practicalities of Usage
		2.4.1 Predicates for a Trial
		2.4.2 Trials Can Provide Confirmatory Evidence
		2.4.3 Clinical Trials Are Reliable Albeit Unwieldy and Messy
		2.4.4 Trials Are Difficult to Apply in Some Circumstances
		2.4.5 Randomized Studies Can Be Initiated Early
		2.4.6 What Can I Learn from