HISTORY OF CLINICAL RESEARCH
Clinical research is the study of health and illness in people. It is the way we learn how to prevent, diagnose and treat illness. Clinical research describes many different elements of scientific investigation. Clinical trials as well as research in epidemiology, physiology and pathophysiology, health services, education, outcomes and mental health can all fall under the clinical research umbrella.
Clinical Trials have a long and rich history. The first Clinical Trial was documented between 562-605 BC.
Old testaments outline how King Nebuchadnezzar 2 ordered the children of royal blood to eat only meat and wine for 3 days and he compared this with David and three other children who eat grains, lenticels and water. After 10 days David Group in noticeably healthier.
1537BC:Ambroise Pare, unintentionally carried out a trial when he ran out of the standard treatment of boiling oil for open wounds. He mixed egg yolk, turpentine and oil of rose. He noticed that wound treated with this mixture healed well than those with standard treatment.
1747:Dr. James Lind was the 1st person to prove the effectiveness of lemon in Scurvy on the group of sailors suffering from scurvy. He placed them all on same diet but fed one groups with additional items – lemons and vinegar. And this group with additional supplement recovered from Scurvy in just 6 days.
1863:Placebo are first used in trials which are non-effective medical Treatment given to controlled group to compare with those from new drug and randomized controlled trials started to emerge in the 20th century
1944:Multicenter trials were introduced and multiple studies were conducted at various sites using same protocol.
1947:Nuremberg code developed 10 basic statements for the protection of human participants in trials.
1964: Helsinki is developed which outlines ethical codes for physicians and protection of participants in trials all over the world.
1988:US FDA is provided with more authority over the new drug approval.
1990: (ICH) was assembled to help eliminate differences in drug development requirement for 3 global pharmaceuticals market in US, Europe and Japan.
2000: A common Technical document (CTD) developed standard dossier used in Europe, Japan and US for proposing data gathered in trials to respective governing authority.