The history of clinical trials dates back to the 18th century. It was then that the Scottish doctor James Lind proved that giving lemon juice to seafarers is effective in the treatment of scurvy. He is considered a pioneer of this field of medicine, although his control sample included only 12 people. An important step in the development of clinical trials was the introduction by the French physician, Pierre Charles Alexandre Louis (1787-1872) of the so-called numerical method for the analysis of medical records. His concept was to compare the results of treatment in patients with similar disease severity. Owing to including statistics in clinical trials, it has become possible to predict which medicinal product will best serve the general public.
The next stage was the introduction of the obligation to carry out toxicological tests. Such a decision was made after about 100 people had suffered from poisoning as a result of taking a drug commonly available in pharmacies. Still, many pharmaceuticals at that time had an uncertain safety profile. Amberson, McMahon and Pinner contributed to the further development of clinical trials. In 1931, they described a method called randomization, which consists in random distribution of the subjects to control groups. The first randomized study was conducted in England in 1948. It concerned a drug for tuberculosis and confirmed its effectiveness.
As early as in 1906, the first legal regulations regarding the conduct of clinical trials appeared in the United States. Of particular importance, however, was the Nuremberg Codex of 1947, which contributed to the protection of patients. The provisions of the document included the need to obtain voluntary and informed consent from participants in clinical trials , the need to justify the actions carried out, in which the benefits outweigh any possible risk, or the possibility of withdrawing the patient’s consent at any time during the process. Important decrees were also introduced by the Helsinki Declaration of 1964. It resulted in the necessity to keep detailed medical records of each clinical trial and obtaining consent from the Ethical Committee before starting any trial. Since 1997 in the area of clinical trials the European Union Directives have been in force. Additionally, in our country, all research projects must be compliant with the Pharmaceutical Law, the Act on Registration of Medicinal Products and the Act on the doctor’s and dentist’s profession since 2001.