A Historic Timeline of Clinical Trials
Clinical trials are structured, supervised studies where the safety and efficacy of a new drug or therapy are tested in an effort to develop new treatments that will help those afflicted with the targeted condition. Clinical trials have a long and rich history; the first clinical trial documented in the Old Testament dates back to 605 BC. Since this first trial, the industry has progressed immensely, refining the process of clinical trials and furthering the methods of protection for the patients involved.
The Old Testament outlines how King Nebuchadnezzar II ordered the children of royal blood to eat only meat and wine for three years. Daniel requested that he and three other children be allowed to eat only bread and water. Daniel and the three children were noticeably healthier and more vivacious than those who were relegated to the wine and meat diet.
A Renaissance surgeon, Ambroise Pare, unintentionally carried out a clinical trial when he ran out of the standard treatment of boiling oil for open wounds. He mixed egg yolk, turpentine and oil of rose and soon noticed that the wounds treated with this mixture healed well as compared to those wounds that became swollen and infected with the standard treatment.
James Lind conducted the first controlled clinical trial on a group of sailors suffering from scurvy. He placed them all on the same diet, but fed one group additional items such as cider and vinegar and fed the other group lemon juice. The group who had the lemon juice supplement recovered from scurvy in just six days.
Placebos are first used in clinical trials. Placebos are non-effective medical treatments given to control groups to compare the results with those from the new drug.
Randomization is introduced to clinical trials. Randomization involves participants randomly receiving one of the treatments, one being a placebo and one being the new drug. Blind clinical trials, where neither group knows which treatment they are receiving, also emerged in the 20th century.
Multicenter clinical trials are introduced, where multiple studies are conducted at various sites all using the same protocol to provide wider testing and better statistical data.
The Nuremberg Code is developed which outlines 10 basic statements for the protection of human participants in clinical trials.
The Declaration of Helsinki is developed which outlines ethical codes for physicians and protection of participants in clinical studies all over the world.
The U.S. FDA is provided more authority and accountability over the approval of new drugs and treatments.
The International Conference on Harmonization (ICH) was assembled to help eliminate differences in drug development requirements for three global pharmaceutical markets: The EU, Japan and U.S. The ICH initiatives promote increased efficiency in the development of new drugs, improving their availability to patients and the public.
A Common Technical Document (CTD) is developed. The CTD acts as a standard dossier used in Europe, Japan and the U.S. for proposing data gathered in clinical trials to respective governing authorities.