History of Clinical trials
Clinical trials are studies conducted on human volunteers to test a new drug or device developed. These studies facilitate the understanding of the efficacy, effectiveness and safety of the new drugs in the treatment of various diseases.
The inception of the clinical studies is not from the modern era; history of clinical trials is very ancient, and as recorded in the Book of Daniel, the 1st clinical trial conducted 605-562 BCE by a King who was a resourceful military leader known as King Nebuchadnezzar. For the sound condition of the people of his kingdom, he kept his people on a strict diet of only meat and wine for 3 years, which was disagreed by some people. Those people were allowed to have pulses, legumes, and water. After 10 days of the experiment, vegetarians were found to be more nourished, so he permitted the use of vegetarian food. This was not the only experiment; several such kind of experiments were performed.
James Lind was the first physician to conduct the 1st clinical trial of the modern era. He was a pioneer of naval hygiene who started the conduct of a trial on the treatment of scurvy on 20th of May 1747. This study by James Lind showed that scurvy is caused by the putrefaction of the body that could be cured through the introduction of acids. The International clinical trial day is celebrated every year on 20th May since 2005.
After the introduction of clinical trials, it took a century to introduce a new breakthrough in the history of clinical trials for the modern era, with the introduction of “Placebo”. Placebo 1st appeared in the medical science literature in the early 1800s. Placebo is a pharmacological preparation given for the psychological relief than for its actual use in the disease.
The first double-blind clinical trial was conducted by the UK medical research council (MRC) in 1943 for the treatment of common cold. This study paved a way to conduct the first randomized trial, which was also conducted by MRC UK for the use of streptomycin in the treatment of pulmonary tuberculosis.
India has a long history in the field of clinical trials in terms of Ayurveda. Ayurveda text contains the observations of various diseases and their treatments. But these details are based on observations only with no written details available. However, in the modern era of clinical research, India is one of the countries conducting a large number of clinical studies for the advancement of the treatments, and to overcome the health related issues.
In the modern era, clinical studies are conducted in different phases that include:
- Phase 0: First-in-human trials to determine if the drug is viable for further development
- Phase 1: To determine a safe dose range and evaluate safety profile
- Phase 2: To assess the efficacy and further evaluate safety
- Phase 3: To confirm efficacy, safety, and therapeutic benefits
- Phase 4: Also termed as post marketing surveillance, used to generate additional data on the drug’s optimal use, risks and benefits in a much wider population.
Overall, the trend of conducting clinical trials is not new; it is coming from several years with the evolvement of newer methods and latest technologies to conduct the clinical trials.