Преглед на историческите аспекти в развитието на клиничните изпитвания
Review of the historical aspects in the development of clinical trials

Summary/Abstract: The evolution of clinical trials passed through a very long and strewn with many difficulties times. From the first study, performed on a bean in biblical times, to the first randomized trial. For all that time the history of clinical trials goes through a series of challenges – scientific, ethical and regulatory mostly. A very popular study for the scurvy disease was conducted by Jane Lind in 1747, contains many of the elements of a modern controlled trial for medicinal products. The study of the effects of Patulin in cold, conducted by the British Medical Research Council (MRC) in 1943, is the world‘s first double-blind controlled study. It paves the way for the realization and the first randomized trial of the effect of streptomycin in tuberculosis, conducted a few years later in 1946 again by the MRC. This extremely important study is a watershed model for the design effort and implementation of clinical trials of drugs, including the creation of precise criteria and requirements for collecting and processing data. He made a huge progress in comparison with other ad hoc studies at that time. Over the years, despite the distinct growth of the discipline and strict requirements in the conduct of clinical trials, studies with streptomycin continues to be regarded as revolutionary and historical development of this field of knowledge about drugs.

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