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History of Clinical Trials

Legumes, lemons and Streptomycin
by

Charlotte Roodt

on 3 July 2013

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Transcript of History of Clinical Trials

Legumes, Lemons and Streptomycin
First Parallel Arm Medical Experiment
Nuremberg, Thalidomide and The Tuskegee Syphilis Study
First Clinical Trial
Why GCLP
Lemons the cure
Nuremberg Code
GCLP
GCLP Course Introduction: History of Clinical Trials
History of Ethics
Declaration of Helsinki


Book of Daniel was in 562 BC when King Nebuchadezzar ordered his people to eat only meat and drink only wine.
Some objected and were given the choice of legumes and water instead.
After 10 days the legume eaters were reported to be healthier than the meat eaters and were allowed to continue their diet.
It would be more than a century before the emergence of another cornerstone of the modern-day clinical trial: the placebo. 1863 that United States physician Austin Flint conducted the first medical experiment comparing a dummy remedy to an active treatment.
The Nuremberg Code is a set of research ethics principles for human experimentation set as a result of the Nuremberg Trials at the end of the Second World War.
Prior to the 1947 Nuremberg Code there was no generally accepted code of conduct governing the ethical aspects of human research, although some countries, notably Germany and Russia, had national policies.
The Declaration developed the ten principles first stated in the Nuremberg Code, and tied them to the Declaration of Geneva (1948), a statement of physician's ethical duties.
Thalidomide
In the late 1950s, thalidomide was approved as a sedative in Europe; it was not approved in the United States by the
FDA.
The drug was prescribed to control sleep and nausea throughout pregnancy, but it was soon found that taking this drug during
pregnancy caused severe deformities in the fetus. Many patients did not know they were taking a drug that was not approved for use
by the FDA, nor did they give informed consent.

"Kefauver Amendments" were passed into law and drug manufacturers were required to prove to the FDA the effectiveness of their products before marketing them.
Tuskegee Syphilis Study
GCLP is a new approach that came about when it was found that the laboratory data did not meet the expectations of GCP (good Clinical practice)
Most of the data in a trial is generated by the laboratory
Inconsistent data laboratory data can results in trials failure
The Tuskegee syphilis experiment was an infamous clinical study conducted between 1932 and 1972 in Tuskegee Alabama by the by the US Public Health Service to study the natural progression of untreated syphilis in rural black men who thought they were receiving free health care from the U.S. government.

The 40-year study was controversial for reasons related to ethical standards; primarily because researchers knowingly failed to treat patients appropriately after the 1940s validation of penicillin as an effective cure for the disease they were studying.
Is documented in the Bible !!
In 1747, Dr. James Lind tested several scurvy treatments on crew members of the British naval ship Salisbury and discovered that lemons and oranges were most effective in treating the dreaded affliction.
In May 1796 Edward Jenner found a young dairymaid, Sarah Nelms, who had fresh cowpox lesions on her hands and arms, using matter
from Nelms' lesions, he inoculated an 8-year-old orphan boy, James Phipps and then when on to inoculate him with pox virus. Luckily he was protected by the cowpox.
Edward Jenner and Cow Pox vaccination
The first vaccine trial
The Placebo
Separating good treatments from quackery

From the 18th century onwards a tug-of-war between mainstream and unconventional medicine erupts.
The challenge became deciphering between health claims derived from legitimate medical inquiry and magic crystals
Out of this dilemma rose 2 concepts that would become vital in ensuring the integrity of a clinical trial: blinding and randomization.
Blinding and Randomization
In 1964, the World Medical Association established recommendations guiding doctors in biomedical research involving human participants. The Declaration governs international research ethics and defines rules for "research combined with clinical care" and"non-therapeutic research"
Since then it has undergone six revisions the last being in 2008
The Declaration of Helsinki protects:
The well being of the human subject should take precedence over the interests of science and society

First Randomized Clinical Trial
Streptomycin for treating TB
1948 saw the first publicized randomized clinical trial for pulmonary tuberculosis
Austin Bradford Hill was credited for designing this trial
GCLP
Organisation and Personnel
Documentation
Facilities
Quality Assurance
Health and Safety
Equipment
Reagents
Materials
Validations - Computer and Method
SOPs and Document Control
Data Management
Archiving of facility and study records
Conduct of Work
Audit process
Quality Control - IQC and EQA
Management of Deviations
Patient Safety
Laboratory Safety
Roles and Responsibilities
Policies, Plan and Documentation
Patient Safety and Confidentiality
Informed consent
Confidentiality
Full transcript