Historical and ethical issues in trial design

Published on October 1, 2007 Updated on October 31, 2018   43 min

Other Talks in the Category: Pharmaceutical Sciences

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One of the most visible forms of contemporary scientific research is the randomized controlled clinical trial. In its basic structure, the clinical trial is a form of experimentation on human subjects that involves administering a potentially useful experimental therapy or intervention to some of the subjects in the trial, while withholding the therapy or intervention from other subjects in the trial. The latter is usually referred to as the control group. Subjects are recruited to the study based on predetermined selection criteria. And after recruitment, the subjects are randomly assigned to either the experimental or the control group. Often, the study participants, and sometimes those carrying out the trial, are blinded, meaning that they do not know which subjects are assigned to which group while the study is going on. Today, this research methodology is often cited as the goal standard of scientifically rigorous research. However, because human subjects are involved, ethical concerns are always present. By using concrete historical examples, this lecture will show how these concerns have been dealt with in the past and explain the underlying ethical principles that should guide researchers who design clinical trials in the future.
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In its most elemental aspect, the clinical trial is predicated on being able to observe a differential response between groups of participants when these groups are exposed to different interventions. One ancient example of this procedure comes from the book of Daniel in the Bible. When the Babylonian king, Nebuchadnezzar, conquered Israel, several Jewish children, including Daniel were taken to the king's palace to be fed rich royal food and wine. But Daniel refused to eat the royal food and suggested the following experiment. "Test your servants for 10 days. Let us be given vegetables to eat and water to drink. Then let our appearance and the appearance of the youths who eat the king's food be observed by you." At the end of 10 days, it was seen that they were better in appearance and fatter in flesh than all the youths who ate the king's rich food. So, the steward took away their rich food and the wine they were given to drink and gave them vegetables. Multiple similar examples could be found throughout all of recorded history, which means that in a sense, the clinical trial is potentially as old as humanity itself.
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Historical and ethical issues in trial design

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