History of Clinical research Flashcards
(21 cards)
10 aspects of clinical research
- comparitibve outcomes
2.controls/placebo
3 Necessity test - Human subjects
- oversight
- checks & balances
7.informed consent - accountability
- prioritization
- systematic review
Comparative Outcomes
-experimental goal
must be supportable or rejectable from study
design.
controls/placebo
a group receiving no
treatment or current standard of care only as
benchmark.
necessity test
Study must be designed to seek
significant health improvements and must
above all do no harm
Human Subjects:
Doctrines of the Nuremberg
code/Helsinki/Belmont Report should be rigorously
applied
oversight
Third party arbiter watches study
and is empowered to modify or end based on
emergent hazards to volunteers.
checksandbalances
Multicenter studies for
example partially eliminate research sponsor
bias. Double blind protocols are another
example.
informed consent
Legal framework for how to
obtain from volunteers and separately specifies
protection for those who cannot legally
consent. (children, mentally handicapped, prisoners)
Accountability:
A study head/leader assumes
all responsibility that the clinical research
activity will meet all legal and ethical standards
and requirements.
prioritization
Mainly with regard to funding,
aims to insure the most pressing human health
needs are those that are addressed.
systematic review
All data is reported , peer
reviewed, and published. Expectation that follow
on studies will continue, perhaps addressing same
question via a different clinical design paradigm.
Book of Daniel
did not really do a clinical study; found a healthy diet
James Lind Scurvy Experiment
FIRST REAL clinical research; different groups tried different foods and found that citrus could prevent & cure scurvy
How did Sir Alexander find penicillin?
having a messy lab
The Tuskeegee Syphillis Study
for 40 years, poor AfricanAmericans test positive for syphilis were used in clinical trials with informed consent and is not given Penicillin, resulting in many deaths and congenital syphilis
Elixir Sulfanilamide Disaster
Chief chemist poisoned kids in a trial by dissolving the drug in a toxic compound. 100 patients died and the chief chemist barely got an repercussions.
World War 2 experiments:
Cruel “medical experiments” done by the German Nazi party on concentration camp prisoners→ resulted in many deaths, disfigurements, or permanent disability
Human Radiation Experiments:
1000s of humans inAmerica became victims of an experiment that analyzed the effects of atomic radiation thehuman by the American government. Many vulnerable groups of people were exposed as well.
Nuremberg Code:
Resulted in a set of ten ethical principles for human experimentation
Nuremberg trials- 23 members of the Nazi party ere tried for crimes
Declaration of Helsinki
: expands upon the 10 principles from the Nuremberg code
The Belmont Report:
response to Tuskegee Syphilis Study
Explains three ethical principles to guide human research
