1. Biomedical Research

2. What is Biomedical Research
Biomedical research is the area of science devoted to the study of the processes of life; prevention and treatment of disease; and the genetic, lifestyle and environmental factors related to disease and health.

3. Scientific Method
Science is a “continuous stream of ideas that are constantly being reshaped.” It is discovery-based and/or inquiry based.
Involves critical thinking, encourages creativity and seeking solutions to problems

4. Observation
Hypothesis
Experiment
Conclusion
Science is a way of making predictions and making decisions for the future

5. Basic Biomedical Research
Conducted to increase fundamental knowledge and understanding of life processes and diseases
It is NOT directed toward solving any particular problem
Provides the building blocks for other types of research

6. Applied Research
Directed toward specific objectives such as developing new medications
Involves the application of existing knowledge to a problem
Can be conducted with animals, computer models and tissue cultures

7. Clinical Research Takes place after the other 2
Clinical research tests a particular medication or treatments in humans
Takes place in a hospital or other health care facility
May lead to the need for further research

8. Biomedical Research Methods
Researchers use a combination of highly interdependent, state of the art methods to understand life processes.

9. Chemical, mechanical, mathematical and computer simulations
Used to simulate living organisms
Helpful in understanding complicated biological processes
Helpful in the preliminary stages of research
Provide ideas about new research directions

10. Limitations and Strengths
Models increase the speed and efficiency with which data can be studied and processed.
If the model is simple, it can be very accurate
Reduces the number of animals needed for research

11. They cannot replace laboratory testing
The reliability is a function of how well the organism being researched is defined
Expensive
Cannot replace living systems

12. In vitro tests
Experiments performed in laboratory containers using tissues or cells.
Literally means “in glass”
Scientists use cell cultures, isolated tissues, in the early and intermediate phases of research

13. Strengths and Limitations
Allow scientist to study a single effect in isolation without interference
Less expensive, less time consuming and more accurate
Able to control more readily
Critical to the study of viruses

14. Toxic effects are complex therefore it cannot be duplicated
Cells grown in culture are not exposed to other living organism processes
Cells do not metabolize toxins in culture the same
Difficult to maintain differentiated cells

15. Nonhuman Animal Models
Animals provide the best surrogate for humans
Results from animal studies can be applied to humans
Animals provide a complex living system

16. Strengths and Limitations
Ethical alternative to using humans
Whole integrated biological system
Animals share the same structures and function as humans

17. Animals are not identical to humans
Research animals are expensive
Animal research is regulated by extensive federal regulations

18. Human Clinical Trials Important component
3 major phases of clinical trials
Phase I-
Phase II
Phase III

19. Strengths and Limitations
Actual human data on the efficacy and safety of new medications
Ethical and moral limitations
Requires extensive pre-clinical testing
Numerous variables affect test data

20. Epidemiological Studies
Epidemiology is the study of disease incidence and its distribution in a population
To prevent disease, need to know what causes it
Three general types of epidemiological studies

21. Experimental Epidemiology
Human equivalent to animal testing such as providing or withholding a substance to determine toxic or beneficial effects.
Greatly limited by ethical and legal considerations and by securing large numbers of people

22. Descriptive Epidemiology
Analyzing data on the extent and distribution of disease
Looking for correlations of disease with diet, air quality and occupation
Often comparisons are made between countries and smaller geographic regions.

23. Observational Epidemiology
Uses data from individuals or small groups
Data is evaluated statistically to determine relationship between variables and disease
Cohort studies are done over time on a homogeneous group
Case-controlled studies uses control group

24. Strengths and Limitations
Epidemiological studies offer direct opportunity to study diseases
Identify patterns and distribution of disease
Considerable human exposure can take place before a toxic effect is detected
Difficult to demonstrate a cause and effect relationship because information is gathered ‘after the fact’
Difficulty in determining the control group

25. Epidemiological Studies:
1775 Sir Percival Pott of England reported chimney sweeps had high incidence of scrotal cancer
Early 1900’s established 14th century black plague was spread from rats to fleas to us
1854 Dr John Snow – cholera from contaminated water pump

26. Epidemiological Studies:
Linked occupational settings: asbestos plants and coal mines to various lung diseases
Hammond-Horn Smoking Study: effect on cigarette smoking on death rates from cancer and other diseases