History And Evolution In Clinical

Research

Evolution In Clinical Research

Let's start with the famous quote of Aldous Huxley : "The charm of
history and its enigmatic lesson consist in the fact that, from age to
age, nothing changes and yet everything is completely different."
Clinical Research has evolved a long way since its inception,
whether documented or not. It traverses a long and amazing
journey. The recorded history of clinical trials dates back to the
biblical descriptions of 500 BC. The journey encompasses from
dietary therapy - legumes and lemons - to drugs. Ranging from the
first recorded trial of legumes in biblical times to the first random and
controlled trial of streptomycin in 1946, the history of clinical trial had
seen a wide variety of challenges : scientific, regulatory and ethical.

Clinical trials
Clinical trials saw the birth and period of the names that
ranges from Egyptian Imhotep to James Lind. As the scientific
advances continue to occur, there will be new ethical and
regulatory challenges requiring dynamic updates in ethical
and legal framework of clinical trials.
This article highlights the major milestones in the evolution of
clinical trials.

Pre Lind era: 605-562 BC

The Old Testament depicts that King Nebuchadnezzar II ordered the
children of royal blood to eat only meat and wine for three years. Daniel
requested that he and three other children would be allowed to eat only
bread and water. Noticeably Daniel and the three children were healthier
and more lively than those who were given the wine and meat diet.
1537
Ambroise Pare,a Renaissance surgeon, unintentionally carried out a
clinical trial when ceased to continue the standard treatment of boiling oil
for open wounds. He experimented by making a mixing of egg yolk,
turpentine and oil of rose and applied to the wounds. Surprisingly noticed
that the wounds treated with this mixture healed well compared to those
which became swollen and infected with the standard treatment.

Lind and trial of scurvy: 1747

James Lind is markedly considered the originator of the modern clinical
research trial because he
was the first to introduce the use of a control group. He conducted the
trial on a group of sailors suffering from scurvy. He prescribed same diet
to all but fed one additional item such as cider and vinegar to one group
and fed the other group with lemon juice. The group who took the lemon
juice supplement recovered from scurvy in just six days.
Arrival of Placebo: 1800
Placebos were first used in clinical trials and emerged as important tools
in medical research. Placebos are non-effective medical treatments
given to control groups to compare the results with those from the novel
drug.

1923
Randomization or blind clinical trials were introduced. This involves giving random treatments to participants
one being a placebo and the other a new drug. Its called blind trial because neither group knew which
treatment received.
1944
This period saw the introduction of multi-center clinical trials where multiple studies are conducted at various
sites; but all use the same protocol to get wider testing and better statistical data.
Evolution of ethical and regulatory frameworks
1947
The Nuremberg Code was developed that outlines 10 basic statements for the safety of human participants
in clinical trials.
1964
The Declaration of Helsinki was developed that outlines ethical codes for physicians and safety of
participants in clinical trials worldwide.
1988
The U.S. FDA was given more authority and accountability over the approval of novel drugs and treatments.
1990
Assembly of the International Conference on Harmonization (ICH) to provide help and eliminate differences
in drug development requirements for three global pharmaceutical markets: U.S. and The EU, Japan. The
ICH initiates promoting increased efficiency in the development of novel drugs and making them more
available to patients and the public.
2000
A Common Technical Document (CTD) was developed. The CTD acts as a standard casebook used in
Europe, Japan and the U.S. for proposing data gathered in clinical trials to respective governing authorities.

Clinical Research review by CRB Tech Solutions

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