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The first clinical trials

The idea of ascertaining the truth through experimentation goes back such a long way that we even find the first experiments mentioned in the Bible. Daniel was chosen along with three companions, all “young men without any physical defect, handsome, showing aptitude for every kind of learning, well informed, quick to understand, and qualified to serve in the king’s palace” [Daniel 1, 4]. The King gave them “a daily amount of food and wine from the king’s table” [Daniel 1, 5], but Daniel was determined not defile himself by eating and drinking such things and proposed an open-label (or blinded for the researcher) trial of ten days’ duration to compare the safety and efficacy of two different diets: “Please test your servants for ten days: Give us nothing but vegetables to eat and water to drink. Then compare our appearance with that of the young men who eat the royal food, and treat your servants in accordance with what you see. So he agreed to this and tested them for ten days. At the end of the ten days they looked healthier and better nourished than any of the young men who ate the royal food” [Daniel, 1, 12-15].

At the beginning of the 11th century, the Persian physician and philosopher Ibn Sina, Avicenna, included in his Canon of Medicine a “Scientific Essay on the Need for Compound Remedies” The purpose of virtually all of them was to define a stable foundation against which the variables studied could be altered one by one.

In 1747, James Lind, the British Army surgeon, conducted one of the first formal clinical trials in order to find a cure for scurvy. He selected 12 sailors with scurvy who had similar characteristics, to keep uncontrolled variations to a minimum, and divided them into groups that followed the same diet with different supplements, such as cider, elixir of vitriol (sulphuric acid), fresh seawater, oranges and lemons. The sailors treated with citrus fruit recovered more quickly but, in spite of the approach of the experiment, prejudice rather than proof prevailed as Lind remained convinced that scurvy was a disease having multiple factors produced by “ill-digested and putrefying food within the body, bad water, excessive work and living in a damp atmosphere which prevented healthful perspiration”.

Another well-known and dramatic case of blind opposition to clinical trials is that of the maternity hospital in Vienna, demonstrated by the Hungarian physician Ignác Fülöp Semmelweis in the 19th century. The maternity hospital had two wards: one attended by medical students, where the death rate rose to as much as 96% and another attended by midwives, where the percentage was far lower. A study on the conditions in which the service was provided in each ward led Semmelweis to put forward the hypothesis that the origin of such a high death rate must be contamination by the students, who attended deliveries straight after their anatomy class. To verify this, he made all students wash their hands with a chlorinated lime solution before attending the women and in this way he succeeded in drastically reducing the death rate. Yet such overwhelming proof did not convince the director of the wards, Dr Klein, who insisted on attributing deaths to the harsh way that the students treated the women. He dismissed more than half of them, ordered hand-washing with disinfectant to be dropped… and death rates returned to “normal”.

Nowadays, clinical trials are crucial to evaluate medicines, substances and techniques. They are implemented by way of research protocols: a document in which the objectives, method and type of statistical analysis are described. Choose Celer Soluciones for your translations of clinical trial protocols, amendments and consent forms. Medical translation is one of our specialisations: experts who translate for experts.