Teaching Clinical Research Methodology by Example has two principal objectives: (1) to tell the story of the research process in action and to provide a glimpse into the minds of the researchers responsible for some of the major advances (and setbacks) in modern medicine; (2) to explain the principles of evidence-based medicine by reviewing the research methods required to prove or disprove a theory.
This text is written in a style accessible to health professionals who do not have a background in clinical epidemiology.
The first section of the book, Causation, begins with an explanation of “casual” and “coincidental” associations and follows with examples:
- Smoking and lung cancer
- Dietary fats and coronary heart disease
- Cause and cure of peptic ulcers,
- Viral infection and cancer of the cervix
- Vaccination and autism
- Venous obstruction as the cause of multiple sclerosis.
The second section of the book explores prevention, treatment, and the ethical principles of clinical trials.
- Treatments presented include surgery for breast cancer, acute lymphoblastic leukemia, use of Viagra, stem cells in breast cancer, and the use of aspirin to treat heart attacks.
- Preventive measures discussed include vaccines, peri-menopausal hormone therapy, aspirin in the treatment of heart attacks, prevention of sudden death after heart attacks, stroke prevention, preventing fatal pulmonary embolism in surgical patients.
- Includes a chapter on assessing net clinical benefits of a treatment.
- Closes with a glossary of methodological terms.
Part 1: Causation
Chapter 1. Associations: How to decide whether they are causal or coincidental
Chapter 2. Smoking and lung cancer
Chapter 3. Dietary fats and coronary heart disease
Chapter 4. Cause and cure of peptic ulcers
Chapter 5. Viral cause of carcinoma of the cervix
Chapter 6. Autism following vaccination
Chapter 7. Cause of multiple sclerosis
Part 2: Prevention and treatment
Chapter 8. Equipoise, a fundamental ethical principle of clinical trials
Chapter 9. Vaccines
Chapter 10. Surgery for breast cancer
Chapter 11. Frontal lobotomy to modify behavior
Chapter 12. Acute lymphoblastic leukemia
Chapter 13. Preventing fatal pulmonary embolism in surgical patients
Chapter 14. Prevention of sudden death after heart attacks
Chapter 15. Bleeding, oral anticoagulants, and stroke prevention
Chapter. 16. Aspirin in the treatment of heart attacks
Chapter 17. Viagra: the little blue pill
Chapter 18. Peri-menopausal hormone therapy
Chapter 19. Stem cells in breast cancer
Chapter 20. Assessing net clinical benefit
Chapter 21. Glossary of methodological terms and their definitions