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INI
INTRODUCTION AND HISTORY
OF CLINICAL RESEARCH
C
O
N
T
E
T
S
N
James lind
Nazi war
Thalidomide tragedy
Sulfanilamide
Syphilis tragedy
• JAMES LIND
James lind was a Scottish physician. he was a pioneer of naval hygiene in the
royal navy.
By conducting one of the first ever clinical
trials, he developed the theory that citrus
fruits cured scurvy.
According to james lind , his trial involve 12
sailors with scurvy, underlying his
understanding of selection of bias and he
kept the clinical condition ,environment and
basic diet constant, two men each following
6 differently daily treatments.
TREATMENTS WERE…..
1.1 LITRES 25ml
18ml
3 Times a day before taking
meals,half a pint of sea
water
+
+ Continued for 6 days and a medicinal
paste made of garlic,dried
raddish,mustard seed and gum myrrh.
These orange and lemon combination
showed the best results.
• NAZI WAR (1940)
165
Easily influenced
C
Here the trigger was INFORMED CONSENT FORM a voluntary consent
given by the subject.
Every clinical trial should be conducted with scientific research.
it should be clearly described in PROTOCOL.
• THALIDOMIDE TRAGEDY
Thalidomide is a blockbuster drug.
Thalidomide first entered into
german market in 1957 as an over
the counter drug
Thalidomide was first
used in Europe.
Europe pharma
company went to
America for approval.
After administering
60,000 children were
affected with limb
defect.
This thalidomide was
also used as morning
sickness – off label
use
After that reporting
system was not
available.
• SULFANILAMIDE TRAGEDY
TEST
DEG was used in
making elixir
which is a
poisonous
substance
DEATH
During October and September
1937 this drug was responsible
for the deaths of more than
1oo people
Toxicity
• SYPHILIS TRAGEDY
The Public Health Service started the
study in 1932 in collaboration with
Tuskegee(then the Tuskegee Institute),
a historically in black college in
Alabama. In the study, investigators
enrolled a total of 600 impoverished
African-American from macon
country, albama.Of these men, 399 had
latent syphilis, with a control group of
201 men who were not infected.vAs an
incentive for participation in the study,
the men were promised free medical
care. While the men were provided with
both medical and mental care that they
otherwise would not have received,they
were deceived by the PHS, who never
informed them of their syphilis
diagnosis and provided disguised
placebos, ineffective methods, and
diagnostic procedures as treatment for
"bad blood".
600 subjects
A
300
(whites)
B
300
(blacks)
1.HTTPS://EN.WIKIPEDIA.ORG/WIKI/JAMES_LIND
5.https://www.washingtonpost.com/news/retropolis/wp/2017/05/16/you
ve-got-bad-blood-the-horror-of-the-tuskegee-syphilis-experiment/
2.https://encyclopedia.ushmm.org/content/en/article/nazi-
medical-experiments
3.https://www.understandinganimalresearch.org.uk/news/sixty
-years-on-the-history-of-the-thalidomide-tragedy
4.https://www.sciencedirect.com/topics/biochemistry-
genetics-and-molecular-biology/elixir-sulfanilamide
REFERENCES
Introduction and History of Clinical Research

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Introduction and History of Clinical Research