History of Clinical research

Question 1

10 aspects of clinical research

Answer 1

1. comparitibve outcomes
   2.controls/placebo
   3 Necessity test
2. Human subjects
3. oversight
4. checks & balances
   7.informed consent
5. accountability
6. prioritization
7. systematic review

Question 2

Comparative Outcomes

Answer 2

-experimental goal
must be supportable or rejectable from study
design.

Question 3

controls/placebo

Answer 3

a group receiving no
treatment or current standard of care only as
benchmark.

Question 4

necessity test

Answer 4

Study must be designed to seek
significant health improvements and must
above all do no harm

Question 5

Human Subjects:

Answer 5

Doctrines of the Nuremberg
code/Helsinki/Belmont Report should be rigorously
applied

Question 6

oversight

Answer 6

Third party arbiter watches study
and is empowered to modify or end based on
emergent hazards to volunteers.

Question 7

checksandbalances

Answer 7

Multicenter studies for
example partially eliminate research sponsor
bias. Double blind protocols are another
example.

Question 8

informed consent

Answer 8

Legal framework for how to
obtain from volunteers and separately specifies
protection for those who cannot legally
consent. (children, mentally handicapped, prisoners)

Question 9

Accountability:

Answer 9

A study head/leader assumes
all responsibility that the clinical research
activity will meet all legal and ethical standards
and requirements.

Question 10

prioritization

Answer 10

Mainly with regard to funding,
aims to insure the most pressing human health
needs are those that are addressed.

Question 11

systematic review

Answer 11

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.

Question 12

Book of Daniel

Answer 12

did not really do a clinical study; found a healthy diet

Question 13

James Lind Scurvy Experiment

Answer 13

FIRST REAL clinical research; different groups tried different foods and found that citrus could prevent & cure scurvy

Question 14

How did Sir Alexander find penicillin?

Answer 14

having a messy lab

Question 15

The Tuskeegee Syphillis Study

Answer 15

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

Question 16

Elixir Sulfanilamide Disaster

Answer 16

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.

Question 17

World War 2 experiments:

Answer 17

Cruel “medical experiments” done by the German Nazi party on concentration camp prisoners→ resulted in many deaths, disfigurements, or permanent disability

Question 18

Human Radiation Experiments:

Answer 18

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.

Question 19

Nuremberg Code:

Answer 19

Resulted in a set of ten ethical principles for human experimentation
Nuremberg trials- 23 members of the Nazi party ere tried for crimes

Question 20

Declaration of Helsinki

Answer 20

: expands upon the 10 principles from the Nuremberg code

Question 21

The Belmont Report:

Answer 21

response to Tuskegee Syphilis Study
Explains three ethical principles to guide human research