臨床研究を再考する Rethinking Clinical Research : Methodology and Ethics

著者名：Schmaling, Karen B./Kaplan, Robert M.

Cambridge University Press（2025/03/20発売）

• 言語：ENG
• ISBN：9781009391764
• eISBN：9781009391740

Description

This book provides a comprehensive analysis of biases inherent in contemporary clinical research, challenging traditional methodologies and assumptions. Aimed at students, professionals, and science enthusiasts, the book delves into fundamental principles, research tools, and ethics. It is organized in three sections: The first section covers fundamentals including framing clinical research questions, core research tools, and clinical research ethics. The second section discusses topics relevant to clinical research, organized according to their relevance in the development of a clinical study. Chapters within this section examine the strengths and limitations of traditional and alternative methods, ethical issues, and patient-centered consequences. The third section presents four in-depth case examples, illustrating issues across diverse health conditions and treatments: gastroesophageal reflux disease, hypercholesterolemia, screening for breast cancer, and depression. This examination encourages readers to critically evaluate the methodologies and assumptions underlying clinical research, promoting a nuanced understanding of evidence production in the health sciences.

Table of Contents

Introduction; Part I. Fundamentals: 1. 'Can it work? Does it work? Is it worth it?'; 2. Core research tools; 3. Clinical research ethics; Part II. Rethinking research: 4. Asking the right questions; 5. Bias in randomized controlled trials; 6. Is bigger always better?: On sample size, statistical significance, and big data; 7. Achieving transparency; 8. Understanding and restraining study costs; 9. Implementation: getting the right interventions to market; 10. Health outcomes: a comprehensive approach; 11. Confronting the crises in peer review and academic publishing; 12. Ontologies: promoting a shared scientific mission; Part III. Case studies: 13. Case study: treating gastroesophageal disease with Omeprazole; 14. Case study: statin therapy for primary prevention of heart disease; 15. Case study: cancer screening; 16. Case study: antidepressant medications; 17. Conclusions and recommendations.