Clinical Trials Timeline ( 605 BC - 1986 AD )
Going down the memory lane of clinical trials is interesting in understanding where we are today. The progress of Science and technology and Pharmokinetics have all contributed to refining and redefining the whole process. The International Conference on Harmonization (ICH) meets from time to time to form and revise guidelines as per Good Clinical Practice.
605 - 562 BC :
The first clinical trial was carried out by King Nebuchadnezzar II . certain members of the royal family had a diet of bread and water and another group had a diet of meat and wine. It was found that those who consumed bread and water were better nourished and more resplendent than those who stuck to wine and meat.
It was by chance that renaissance surgeon Ambroise Pare' treated his patients with a mixture of oil of rose , turpentine and Egg Yolk for treating open wounds compared to the traditionally used formula. He found that the wounds treated with the experimental mixture were not painful whereas those using the traditional formula were found to be swollen and red.
Seafarers discovered that by adding oranges and lemons to their diet , there was an improvement in their general health.
147 years after the discovery made by Seafarers , James Lind conducted the first controlled parallel group clinical trial to prove the effectiveness of Lemon Juice in preventing
19th Century :
Placebo Controlled trials started emerging.
20th Century :
Randomized trials started emerging.
The introduction of Multicenter studies was seen, where the same trial was conducted at different sites using the same protocol and finally all the centers results were assessed together.
For the safety and protection of Clinical trial participants , the Nuremberg Codex established a 10 point system .
The Declaration of Helsinki , was developed by the World Medical Association in order to provide a list of ethical codes for both physicians and participants involed in the clinical trials.
The development and Implementation of Good Clinical Practice ( GCP) guidelines in individual countries.
The biological revolution has given rise to many new and promising disciplines such as genomics, proteomics , metabolomines and bioinformatics which is bound to lead to a steady acceleration in drug research and discovery in the years to come.