Biomedical Research

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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

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

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

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