BIOMEDICAL RESEARCH METHODS
What are biomedical research methods?
An integrated approach using ___________________________________________, in vitro
tests, whole animal studies and human epidemiological studies and ______________________
is currently the best approach to advance science, ____________________________________,
and treat, cure and prevent disease
Breaking it down…
Chemical, mechanical, mathematical and computer simulations__________________________
in the preliminary stages of research where they can ___________________________________
These are effective research models but they _________________________________________
Computer simulations are an effective research tool because____________________________
___________________________________________________________.
In vitro tests (meaning “in glass”) are __________________________________using tissues or
cells. These tests are most useful during _______________________________________ to
study a single effect of a substance in isolation.
An example of a limitation to in vitro studies would be _________________________________
____________________________________________________________.
In vitro studies are critical to the study of ____________________________________________
_______________________________.
Non-human animal models ___________________________________________ on the
functioning of a living system, and ____________________________________________ of
how humans will react to a new drug or medical procedure.
Animals provide ______________________________________________ for humans in the lab
Animals share the ________________________________(cells, tissues, organs) as humans
People with concerns about animals in research ______________________________________
_____________________________.
Human studies _______________________________________________________________
and evaluating them in carefully staged _______________________________ using informed
human volunteers.
When humans are used in biomedical research studies, ________________________________
3 Main Phases of Human Clinical Trials
In Phase I clinical trials, ________________________________________________, including
how it is ___________________________________________________________________ and
the likely therapeutic effect. This phase involves a small number of _____________________
and takes approximately one year.
Phase II trials ____________________________ that help determine a drug’s effectiveness.
These studies involve ___________________________________. Simultaneous animal and
human tests ____________________________________________________ as researchers
continue to assess the safety of the drug. This phase takes approximately _______________.
Phase III are conducted to __________________________________ and further identify any
adverse reactions. Clinical testing at this point is extensive, involving__________________ in
medical clinics and hospitals. This phase takes ____________________________________.
After human clinical trials are completed, firms _________________________________ with
the FDA. The NDA is a ______________________________________ on drug structure, the
scientific rationale and ____________________________________, pre-clinical animal and
other _________________________________, all h from human clinical testing results, drug
formulation and production details and _____________________________________. This
takes approximately ____________________________.
Currently, it takes ____________________________________ from initiation of animal and
other laboratory studies through all phases of clinical trials and ________________________
__________________. For each new medicine approved, the cost is ____________________
___________________________.
Epidemiological studies ____________________________________________. These studies
look at ________________________________________
May be divided into three general types: __________________________________________
Experimental epidemiology is the _______________________________________providing or
withholding a substance to determine its _______________________________.
Such studies are greatly limited ____________________________________________ as well as
the difficulties involved in _____________________________________________________ .
Descriptive epidemiology __________________________________________________ or other
conditions in various populations, _________________________________________________.
Observational epidemiology uses ______________________________________________. Are
Data are evaluated statistically to determine _________________________________ between
a particular variable and disease.
Strengths: Epidemiological studies offer _______________________________ to study the
effects in humans _________________________________________________________. These
studies are also useful in ______________________________ in disease or injury distribution.
These patterns may be _____________________________________.
Limitations: A major disadvantage of epidemiological studies is __________________________
____________________________before a toxic effect is detectable, ______________________
like cancer that take many years t develop.