Biomedical Research

1. Biomedical Research

2. Biomedical Research • Definition • Study of the processes of life; the prevention and treatment of disease; and the genetic lifestyle and environmentmental factors related to disease and health

3. Types of biomedical research BASIC APPLIED CLINICAL

4. BASIC • Research conducted to increase fundamental knowledge • Not directed toward solving any particular problem

5. Basic • Focuses on understanding normal life processes and disease • Molecular • Cellular

6. BASIC • Provides building blocks for other types of research –is the first stage • Writing a research paper on a particular disease would be an example

7. APPLIED Directed toward specific objectives, such as the development of a new drug, treatment or surgical procedure

8. Applied • Conducted with: • Animals (primarily) • Tissue cultures • Computer models • And humans

9. Clinical • Usually last stage of medical research • Used when other forms of research have taken place – most clinical trials involve humans • Used to treat potential drugs and treatments in humans • Builds on what is done in basic and applied stages

10. CLINICAL • Takes place : • Hospital • Clinical setting for health care • Applies directly to: • Prevention, diagnosis, or treatment of a specific disease in the individual or group of individuals or the rehabilation of the individual

11. Clinical • Broad variety of activities and areas of study • Human clinical trials (Research study for a new medicine or treatment) • Psychosocial and behavioral research • Disease control research (Research study for a particular disease)

12. Clinical • Edward Jenner • Inoculated son with cow pox • 6 weeks later- exposed son to smallpox • Son was resistant • “immunization”

14. Biomedical Research Methods • 1. Chemical, mechanical, mathematical, and computer simulations • 2. In vitro tests • 3. Non-humans animal models • 4. Human Studies • 5. Epidemiological Studies

15. Strengths of Chemical, Mechanical, Mathematical, and Computer Simulations • 1. Computers increase speed and efficiency with which data is used and processed • 2.Pattern recognition programs enable scientists to compare characteristics of one compound to another

16. Strengths of Chemical, Mechanical, Mathematical, and Computer Simulations • 3. Can extrapolate data • A. From high – dose experimental exposure to low-dose • B. From animals to humans 4. Reduces the numbers of animals needed for research

17. Using Computers as a Research Method

18. Limitations of Chemical, Mechanical, Mathematical, and Computer Simulations • Limitations • 1. Cannot replace laboratory testing • 2. Computers do not generate data – they only process existing data • 3. Computers equipment and software is expensive

19. In Vitro Tests In Vitro – “in glass” Takes place in an artificial environment (Laboratory)

20. Strengths of In Vitro Studies • 1. Allow scientists to study a single effect in isolation • 2. Less expensive, less time, more accurate, and easier to control than in vivo (whole animal) systems

21. Strengths of In Vitro Studies • 3. More precise results as a result of ability to control temperature, acidity, oxygen levels and environmental conditions • 4. Critical to the study of viruses which grow only in living cells

22. Limitations of In Vitro Studies • 1. The time from chemcical exposure to toxic effect too complicated to be duplicated in vitro • (Cancer as a multi-step process for example) • 2. Cells grown in cultures are not exposed to other functions taking place in a living organism

23. Limitations of In Vitro Studies • 3. Cells do not metabolize toxins in a culture the same way as in the whole body • 4. Difficult to maintain differentiated cells in a culture • 5. Cultures cannot tell us how a substance affects a complex system

24. Non-Human Animal Models • Animals provide the best known surrogate for humans in the lab • Similarities between animals and humans outweigh differences

25. Strengths of Animal Models • 1.Ethical alternative to using humans • 2.Animals provide a whole, integrated complex biological system • 3. Animals share the same structures (cells, tissues, organs, and systems) as humans and function in much the same way

26. Strengths of Animal Models • 4. Scientists can design experiments where they can control for more variables than with humans

27. Limitations of Animal Models • 1. Animals are NOT humans so results must be extrapolated • 2. Research animals are expensive to purchase, house, feed and provide with veterinary care • 3. Use of animals are governed by federal regulations

28. Human Studies • Most often used in developing prescription drugs • Looking for the answers to the questions below: • A. Is the drug biologically active in humans? • B. Is the drug safe in humans?

29. Human Studies – Three Major Phases of Clinical Trials • Phase I • 1. Determine drug’s interaction with the human system • 2. Involves a small number of healthy volunteers • 3. Takes one year

30. Human Studies – Three Major Phases of Clinical Trials • Phase II • 1. Controlled tests that help determine a drug’s effectiveness on certain organs, etc. • 2. 100-300 volunteer patients • 3. Simultaneous animal and human tests to assess safety • 4. Takes 4 years

31. Human Studies – Three Major Phases of Clinical Trials • Phase III • Done to confirm results of earlier tests and identify any adverse reactions • 2. Clinical testing extensive – Need 1000 – 3000 volunteer patients • 3. Takes 3 years

32. After Clinical Trails • Firm files New Drug Application (NDA) with FDA • Takes 2 ½ years to complete • In all – 12 years from initiation of studies to FDA approval • Each new medicine approved costs millions of dollars

33. Human Clinical Trials Strengths Limitations 1. Ethical and moral considerations of using human volunteers as test subjects 2. Numerous variables, which may affect test data, are introduced when humans are used • Have actual human data (how it affect human)

34. To Be Continued ….