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Clinical Trials Day
May 21, 2018
Clinical Trials Day is celebrated around the world each May to recognize the day that James Lind started what is often considered the first randomized clinical trial aboard a ship on May 20, 1747.
HERE’S THE STORY*
May 1747. The HMS Salisbury of Britain’s Royal Navy fleet patrols the English Channel at a time when scurvy is thought to have killed more British seamen than French and Spanish arms.
Aboard this ship, surgeon mate James Lind, a pioneer of naval hygiene, conducts what many refer to as the first clinical trial.
Acting on a hunch that scurvy was caused by putrefaction of the body that could be cured through the introduction of acids, Lind recruited 12 men for his “fair test.” (Ed: Historians are at odds regarding whether Lind secured Institutional Review Board approval before proceeding with subject recruitment, but largely agree his Informed Consent process did not measure up to modern standards.)
From The James Lind Library:
Without stating what method of allocation he used, Lind allocated two men to each of six different daily treatments for a period of fourteen days. The six treatments were: 1.1 litres of cider; twenty-five millilitres of elixir vitriol (dilute sulphuric acid); 18 millilitres of vinegar three times throughout the day before meals; half a pint of sea water; two oranges and one lemon continued for six days only (when the supply was exhausted); and a medicinal paste made up of garlic, mustard seed, dried radish root and gum myrrh.
(Ed: The existence accountability logs is yet another area of disagreement among historians, but many agree that Lind’s Essential Documents binder might have settled at the bottom of the English Channel.)
Those allocated citrus fruits experienced “the most sudden and good visible effects,” according to Lind’s report on the trial.
Though Lind, according to The James Lind Library, might have left his readers “confused about his recommendations” regarding the use of citrus in curing scurvy, he is “rightly recognized for having taken care to ‘compare like with like’, and the design of his trial may have inspired” and informed future clinical trial design.
*”History” presented here with a fair amount of humor. Accuracy not 100% guaranteed.