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“Any research study that prospectively assigns human participants or groups of humans
to one or more health-related interventions to evaluate the effects on health outcomes.
Health outcomes include any biomedical or health-related measures obtained in patients
or participants, including pharmacokinetic measures and adverse events”.
Anonymous:
“Clinicaltrials are designed to help us find out how to give a new treatment
safely and effectively to people. All patients who participate in a clinical trial provide
information on the effectiveness and risks of the new treatment”.
HISTORY OF CLINICAL TRIALS-1
James Lind, a Scottish Naval Physician, is regarded as Conducting the first Clinical Trial.
During a Sea Voyage in 1747, he chose 12 Sailors with similar severe cases of Scurvy, and
examined Six Treatments, each given to Two Sailors: Cider, Diluted Sulphuric Acid, Vinegar,
Seawater, a Mixture of Several Foods Including Nutmeg & Garlic, & Oranges & Lemons.
They were made to Live in the same part of the ship and with the Same Basic Diet.
Lind felt it was important to standardize their Living Conditions to ensure that any change in
their disease is unlikely to be due to other factors.
After about a week, both sailors given fruit had almost completely recovered, compared
to little or no improvement in the other sailors. This dramatic effect led Lind to Conclude that
Eating Fruit was Essential to Curing Scurvy, without knowing that it was Specifically Due to
Vitamin C. The Results of his Trial were Supported by Observations Made by other Seamen
and Physicians.
Lind had little doubt about the value of fruit. Two important features of his trial were:
Acomparison Between Two or More Interventions
An Attempt to Ensure that the Subjects Had Similar Characteristics.
That the requirement for these two features has not changed is an indication of how
important they are to conducting good trials that aim to provide reliable answers.
Allocating Subjects using a Random Number List meant that it Was Not Possible to
Predict What Treatment Would be Given to Each Patient, thus Minimizing the Possibility of
Bias in the Allocation.