The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them.Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation.Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more.This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
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Table of contents
- Modern Methods of Clinical Investigation
- Copyright
- Acknowledgments
- Preface
- Contents
- List of Abbreviations
- 1 Medical Technology Development: An Introduction to the Innovation-Evaluation Nexus
- 2 The Selection of Endpoints in Evaluative Research
- 3 Advances in Health Status Measurement: The Potential to Improve Experimental and Non-Experimental Data Collection
- 4 What Is Outcomes Research?
- 5 Strengths and Weaknesses of Health Insurance Data Systems for Assessing Outcomes
- 6 Prescription-Event Monitoring: An Example of Total Population Post-Marketing Drug Surveillance
- 7 The Role of Decision Analysis in the Translation of Research Findings into Clinical Practice
- 8 Meta-Analysis: A Quantitative Approach to Research Integration
- 9 An Introduction to a Bayesian Method for Meta-Analysis: The Confidence Profile Method
- 10 Should We Change the Rules for Evaluation Medical Technologies?
- 11 Attitudinal Factors That Influence the Utilization of Modern Evaluative Methods
- Appendix A Comparing the Development of Drugs, Devices, and Clinical Procedures
- Appendix B Workshop Agenda
- Appendix C Contributors
- Index
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