Each and every drug that is made available to the public in the market necessarily undergoes certain testing procedures. This process of medical drug testing is popularly known as clinical trials. This step is necessary to understand the effect of any new drug on medical volunteers. The whole procedure is conducted under the vigilant eyes of scientists or medical researchers who constantly develop new drugs.
A clinical trial is not a new concept, it is an ancient practice, and even the Holy book of Bible has mentioned such clinical research by medical practitioners, as old as 500 BC era. In the year 1000 AD, a scientist from Persia had written in his book about clinical trial processes that were done firstly on animals and then volunteering human beings.
Salient Points on the History of Clinical Experiments
- The practice of research trials for new medicinal drugs was followed in every century, from the 15th century to the 19th
- The very first recorded clinical procedure was done in 1537 by surgeon Mr. Ambroise Pare on wounded soldiers with natural medical ingredients.
- Later, in the 17th century again a ship surgeon known as James Lind conducted an experimental trial on soldiers who were suffering from the scurvy disease.
- James Lind is popularly known as the father of clinical trials.
- The 19th century saw the advent of many advanced forms of clinical trials. In the year 1923, medical practitioners started conducting blind trials for new placebos drugs.
- Later in 1927, the Food, Drug and Insecticide Administration (FDA) bureau was formed by US government.
- In 1944, numerous clinical trial centers were developed all across the world to facilitate clinical laboratories and research spaces for doctors, scientists, and medical researchers.
- In 1995, EMEA was officially launched for developing licensed medical procedures (centralized and decentralized).
500 BC - The Hippocratic Oath
Hippocrates, “the father of Western Medicine,” is believed to have created the oath that bears his name over 2,400 years ago. By taking it, physicians and other healthcare professionals swear to practice medicine justly and ethically. The responsibility of practicing medicine ethically carries over to clinical research, where the protection of human subjects is paramount. Source: www.imarcresearch.com
The year 1994 saw several notable changes in FDA policies to facilitate the participation of women researchers in the clinical drug trial processes. Later, FDA also issued certain guidelines aimed at quality analysis of the volunteer patient groups, to be categorized into many sub groups such as gender groups, elderly groups, and pediatric study group to name a few.