I’m a nurse…I work in clinical research and I had no idea today was such an important day in this industry. A little bit of reading and I have learned quite a bit.
While the recorded history of clinical research goes all the way back to Biblical times (Book of Daniel); James Lind, MD, is credited as the first physician to have documented a controlled clinical trial of the modern era. While working as a surgeon on a ship, he was appalled by the high mortality of scurvy amongst the sailors. His description of the trial covers all the essential elements of a controlled clinical trial.
Lind describes“”On the 20th of May 1747, I selected twelve patients in the scurvy, on board the Salisbury at sea. Their cases were as similar as I could have them. They all in general had putrid gums, the spots and lassitude, with weakness of the knees. They lay together in one place, being a proper apartment for the sick in the fore-hold; and had one diet common to all, viz. water gruel sweetened with sugar in the morning; fresh mutton-broth often times for dinner; at other times light puddings, boiled biscuit with sugar, etc., and for supper, barley and raisins, rice and currants, sago and wine or the like. Two were ordered each a quart of cyder a day. Two others took twenty-five drops of elixir vitriol three times a day … Two others took two spoonfuls of vinegar three times a day … Two of the worst patients were put on a course of sea-water … Two others had each two oranges and one lemon given them every day … The two remaining patients, took … an electary recommended by a hospital surgeon … The consequence was, that the most sudden and visible good effects were perceived from the use of oranges and lemons; one of those who had taken them, being at the end of six days fit for duty … The other was the best recovered of any in his condition; and … was appointed to attend the rest of the sick. Next to the oranges, I thought the cyder had the best effects …” (Dr James Lind’s “Treatise on Scurvy” published in Edinburgh in 1753)
Fascinating!
Have you ever thought about how new medicines are developed? New medical devices? New treatments?
You guessed it…clinical trials! While this video has a European approval focus…the concept in the USA is the same (in fact often we are working on a trial that has already received approval in Europe but is still in the trial process in the US)…with the final USA approval being with the FDA, the US Food and Drug Administration.
Have you participated in a clinical trial? I’d love to hear your story!
~Jan
Resources:
http://www.acrpnet.org/MainMenuCategory/Membership/International-Clinical-Trials-Day.aspx
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3149409/
http://www.fda.gov/default.htm
Jan Orga 