Biomedical Research

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

Types of biomedical research BASIC APPLIED CLINICAL

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

Basic Focuses on understanding normal life processes and disease Molecular Cellular

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

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

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

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

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

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)

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

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

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

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

Using Computers as a Research Method

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

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

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

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

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

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

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

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

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

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

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?

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

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

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

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

Human Clinical Trials Strengths Limitations Have actual human data (how it affect human) 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

To Be Continued ….