Clinical Research

The past and the future of Clinical Trials

The history of drug discovery makes an interesting read. Many of the drugs which are used today were discovered accidentally or by chanceThe two ancient Indian scripts called the Charkha Samitha and the Sushruta Samitha was compiled as early as in 200 B.C. and 200 A.D. and these scripts can be traced back to India’s history of drug discovery and proficiency. The history of clinical trials is no less interesting and it is in understanding of where we are today.

It is thought that the first clinical trial was conducted in between 562-605 BC by King Nebuchadnezzar II. It is ironical that the first documented experiment resembling a clinical trial was conducted by a military leader and not by a scientist or a doctor. At some point of time during his reign, Nebuchadnezzar ordered his people to follow a diet of meat and wine which he thought was the best to perpetually keep them in good health. But there was an objection to this idea by the young members of  his family. The king was curious to know about the aftermath of having a diet of legumes and water, so he allowed the rebels to follow a diet of the same, and evaluated their health after a period of 10 days. When Nebuchadnezzar’s experiment ended, the legume eaters were found to be in better health than those of the latter and hence the king allowed them to continue their diet.

In the 1600, seafarers discovered that by adding lemons and oranges to their diet, they tend to improve in their general health. 147 years later, Dr.  James Lind was the first person to conduct a parallel arm experiment to prove the effectiveness of lemon in Scurvy. During the 18th and the 20th century, placebo controlled trials and randomized controlled trials started to emerge. In the year 1863, a physician from the United States, called Dr. Austin Flint, conducted the first experiment on comparing a dummy remedy with an already existing remedy. He treated 13 patients of rheumatism with an herbal treatment instead of existing active therapy. The year 1944 saw the introduction of multicenter studies wherein the same protocol of a clinical trial was followed across different sites and the results of all centers later assessed together. The evidence of a widely publicized clinical trial was the brainchild of a British Statistician Austin Bradford Hill, who is termed as the “father of modern day clinical science”. The trial was a test of streptomycin for treating pulmonary tuberculosis.

The year 1947 saw a major shift in the way clinical trials were being conducted, for the Nuremberg Code was established with its 10 point system. The Declaration of Helsinki came next, developed by the World Medical Association in order to provide a list of ethical codes for physicians and subjects alike participating in clinical trials. The year 1986 saw the development of and implementation of Good Clinical Practices (the GCP) guidelines in individual countries.

Technology is always on its way of marching forward and promising disciplines continue to emerge, which will lead to acceleration in drug research and discovery in the future as well.

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