History of Clinical Studies

First recorded clinical trial describes the person called as Daniel who followed a pulses diet and water to show that the diet is better than the meat-wine combination which was recommended by King Nebuchadnezzar II at that time.

The first clinical trial of a novel therapy was conducted unintentionally by the Renaissance surgeon Ambroise Parè in 1537. He used a concoction of turpentine, rose oil and egg yolk to prevent the infection of battlefield wounds, noting that the new treatment was much more effective that the traditional formula.

The father of clinical trial (James Lind) introduced the first control group in his clinical experiments to demonstrate the fact that citrus fruits were useful and effective in prevention of scurvy disease. The study performed at sea on board the Salisbury (1747). All scurvy patients treated with same general diet with additional items like cider, elixir seawater, vitriol, vinegar, nutmeg, oranges and lemons etc. within six days of therapy, the patients shows relief from scurvy who were taking citrus fruits.

The modern clinical studies are begun from 1800 onwards, in which more attention given to design the study. In addition, the placebos and idea of randomization were first introduced in 1863 and 1923, respectively.

The first clinical trial with randomization control group design performed in 1948 by the MRC (Medical Research Council) to demonstrate the use of streptomycin in the treatment of pulmonary tuberculosis. Also the study used the double blind assessment method to enable the unbiased method of analysis of the clinical study results.

From 1945 onwards, the ethical and patients welfare has become increasingly important in clinical trials, which yield strict rules and regulation, compiled in form of documents such as the Nuremburg Code (1947), the Declaration of Helsinki (1964, amended in 1975, 1983, 1989, 1996, 2000 and 2001).

The current clinical trials have thus developed in the process of standard procedures; strictly focus on patient safety; voluntary participation and informed consent process to all participants.