The First Published Clinical Trial

Today’s clinical trials are precise, controlled, and highly regulated. Government and sponsor oversight ensure patient safety. After the studies are completed, the results are published. 2500 years ago, the process was not well established, but at least one trial still made it to publication. The Ketuvim and Old Testament describe Daniel performing the earliest clinical trial on record.

Inclusion criteria dictated that the children had “no blemish” and that they had an aptitude for “all wisdom, cunning in knowledge, and understanding science.” Children also had to be able to stand and learn the language. All children were part of a vulnerable populationcaptives. These days research involving vulnerable populations is well-regulated and must be justified to a high degree in the modern era. Babylonian rules were decidedly more lax.

The trial had a simple setup with two groups. It was a diet-based trial. The “control” group consisted of an unknown number of children who ate meat and wine. The “experimental” group contained only four children who did not want to desecrate their bodies with the meat and wine of the King. They ate pulses (beans) and water instead. The protocol specified that the trial should occur for ten days. At the end of the experimental period, the experimental group was “fatter in flesh” and “ten times better than all the magicians and astrologers that were in all [Nebuchadnezzar’s] realm.” It is unclear what data points were used to determine this, but the results were hard to argue with.

Daniel’s clinical trial had some serious pitfalls. The sample size was very low. Patients and investigators were unblinded - aware of what trial group they were in. No literature review was performed, and no hypothesis was stated. Additionally, though the results were published, they lack a methods section or other information to allow for replication of the study. We should acknowledge the trailblazing effort of this trial. We should also appreciate the gains in oversight, accountability, documentation, and safety that have taken place in the millennia since.

Staff Writer / Editor Benton Lowey-Ball, BS, BFA