Rethinking Clinical Research
Methodology and Ethics

Exploring biases in health research, it covers fundamental principles, tools, and ethics, offering case examples for critical evaluation.

Karen B. Schmaling (Author), Robert M. Kaplan (Author)

9781009391764, Cambridge University Press

Hardback, published 20 March 2025

367 pages
22.9 x 15.2 x 2.1 cm, 0.705 kg

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.

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.

Subject Areas: Psychological methodology [JMB]