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How and when were clinical trials born?

- INVESTIGATORS

How and when were clinical trials born?

Clinical trials are what guarantee pharmacological safety and the improvement in the method allows drugs and therapies to be developed today with the highest ethical, scientific and quality guarantees.

But there was a “first clinical trial”, the cornerstone, the origin of everything; a history of sailors and diseases that dates back to 1746.

Scurvy led James Lind to conduct the first clinical trial..

At that time, scurvy – a disease caused by a lack of vitamin C or ascorbic acid – was developing at an alarming rate among sailors who suffered severe gum lesions, skin sores, became prostrate and died.

On one of those long voyages, James Lind – a Scotsman now considered the father of naval medicine – divided 12 sick sailors into six pairs and each pair was given a different supplement to their diet: cider, vitriolic elixir (diluted sulfuric acid), vinegar, seawater, two oranges and a lemon, or a purgative mixture.

As a result of what has been considered “the first clinical trial in history”, only the two sailors who took the fruit improved. Thus it was empirically proven that citrus fruits prevented scurvy. With this act, Lind initiated the way to modern medicine as we know it today.

The success: the control of variables: Lind chose patients with similar symptoms, kept them in the same place and provided them with a common diet.

As a term, clinical trial appeared for the first time in an anonymously published journal called Lancet in 1931, coinciding with the constitution of the UK Clinical Trials Committee. A few years later Sir Austin Bradford Hill, today considered the father of the modern clinical trial, published the first book on the subject: “Principles of Medical Statistics”.

Clinical trials are the basis of scientific research.

The first controlled clinical trial dates back to 1946; just two years after the discovery of streptomycin to test the efficacy of this drug in the treatment of tuberculosis.

276 years after that first trial, clinical research continues to evolve constantly and clinical trials represent the possibility of access to new drugs or treatments, essential for access to a better quality of life and, in many cases, for survival.

Highly regulated, clinical research is governed by the regulatory bodies of each country, but also by international standards, global good clinical practice and global and local ethics committees. 

The role of those 16th century sailors is similar to that of VOLUNTEERS today: those billions of people around the world who enable billions of others to benefit from their generosity.

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