Department of Medicine, McMaster University, Hamilton, ON, L8P 1H6, Canada.
Haldimand War Memorial Hospital, 400 Broad Street, Dunnville, ON, N1A 2P7, Canada.
Inflammopharmacology. 2024 Feb;32(1):61-71. doi: 10.1007/s10787-023-01303-z. Epub 2023 Aug 3.
The term clinical trial implies an investigation of a therapeutic intervention in the pursuit of evidence of benefit, short or sustained, and observations on the possibility of toxicity related to the therapeutic intervention. It is possible that the first clinical trial took place in the court of the Babylonian King Nebuchadnezzar circa 600 BC, as recorded in Chapter 1 of the Book of Daniel, verse 3-20. However, it is in the last 500 years that there has been good written documentation at attempts to interpret therapeutic benefit from the use of treatments. Lind's demonstration on the usefulness of oranges and lemons in the treatment of scurvy in 1747, and the unethical experiment by Edward Jenner (1749-1823) on the inoculation in 1796, of an 8-year-old boy, with cow pox obtained from a milk maid, followed by an attempt to give the young boy smallpox by direct inoculation 18 days later, are striking examples of clinical trials. Human ethics, strict clinical observations, statistics, the governed scientific purity of therapeutic agents, and safety testing of therapeutics, devices, and physical interventions, have created the basis for the modern clinical trial.
临床试验一词意味着对治疗干预措施进行调查,以寻求短期或长期的疗效证据,并观察与治疗干预相关的毒性可能性。最早的临床试验可能发生在公元前 600 年左右的巴比伦国王尼布甲尼撒的法庭上,这在《但以理书》第一章第 3-20 节中有记载。然而,在过去的 500 年里,人们对尝试从治疗中解释治疗益处有了很好的书面记录。1747 年,林德(Lind)证明了橙子和柠檬在治疗坏血病方面的有效性,而爱德华·詹纳(Edward Jenner)(1749-1823 年)在 1796 年进行的一项非伦理实验中,将从一名挤奶女工身上获得的牛痘接种到一个 8 岁男孩身上,然后在 18 天后试图直接接种天花给这个小男孩,这些都是临床试验的典型例子。人类伦理学、严格的临床观察、统计学、治疗药物的科学纯度管理以及治疗、设备和物理干预的安全性测试,为现代临床试验奠定了基础。