From Legumes to Drugs—The History of Clinical Trials

A clinical trial is defined as a medical study involving consenting human subjects who go through one or a series of tests in an attempt to evaluate the safety and efficacy of medical treatment or procedure.

Its evolution spanned across centuries, with many events marking a shift in the medical community and approaches.

The successes and mistakes committed throughout the history of clinical trials helped shape their conduct in line with ethical and regulations.

DoNotPay has prepared this article about some of the most important events in the history of clinical trials, but, before that, check out its clinical trial search platform.

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When Did Clinical Trials Start?

Clinical trials trace their roots back to the biblical times and the “Book of Daniel” containing the first recorded medical experimentation, which was conducted by King Nebuchadnezzar.

The king of Babylon mandated that his people only eat meat and drink wine, a diet considered to maintain perpetual health. A few royal vegetarians dissented, and the king allowed them to instead consume legumes and water for the next 10 days and then assessed their health.

This rudimentary test showed that the vegetarians were better nourished, so the king allowed them to proceed with their regimen.

A Successful Clinical Trial by Accident

The first novel therapy clinical trial was conducted by a French surgeon Ambroise Pare in 1537. Charged to treat the wounded battlefield soldiers, Pare ran out of oil used for cauterization, a conventional treatment at the time, due to short supplies. Desperate, he applied a mixture of turpentine, egg yolks, and rose oil, fearing the worst.

In the morning, he saw that the new treatment was more effective than the conventional one. The new medicine alleviated the symptoms, such as pain, fever, and swelling, which other wounded soldiers continued to display.

Famous Clinical Trials—Medical Research History Milestones

Medical experimentation history is full of milestones that contributed to shaping the clinical trial as we know it today. Some of the pivotal examples in the evolution of clinical research are:

• The Lind clinical trial
• The placebo inclusion
• The patulin clinical trial
• The Streptomycin clinical trial

The Lind Clinical Trial

Seeing high mortality among scurvy-affected sailors, James Lind, a Scottish naval surgeon, organized and carried out the first controlled clinical trial. He selected 12 patients, divided them into twos, and administered different treatments to each pair. Those were:

1. A course of sea-water
2. 25 drops of vitriol
3. A quart of cyder
4. Two spoons of vinegar three times a day
5. A standard medicine used in hospitals
6. Two oranges and a lemon

The last treatment showed the best efficacy, and Lind recorded the trial in his “A Treatise on the Scurvy.”

The Placebo Inclusion

A U.S. physician Austin Flint organized the first clinical trial with a placebo application in 1863.

Flint’s study aimed to compare the respective effects of the placebo and active therapy on the patients suffering from rheumatic fever, showing no difference between the two as the rheumatic fever symptoms naturally dissipated in time.

The study was crucial as it emphasized the importance of a placebo in identifying the positive effects of active therapies.

The Patulin Clinical Trial

In 1943 and 1944, The Medical Research Council (MRC) enrolled over a thousand people in a trial to investigate the effectiveness of patulin for the common cold.

This was the first double-blind comparative clinical trial ever to be conducted, involving rigorous efforts to keep both the subjects and medical staff blinded to the treatment.

Though the results showed that patulin was ineffective, the study’s double-blind approach lay the groundwork for subsequent trials.

The Streptomycin Clinical Trial

Another MRC clinical trial involved testing the effectiveness of a new promising antibiotic—Streptomycin—as a pulmonary tuberculosis treatment.

The trial began in 1947 and was the first randomized clinical trial to take place. Dr. Austin Bradford Hill, the appointed statistician, was the one who instituted randomization instead of alternation for patient allocation.

The trial was considered exemplary in terms of execution, enrollment criteria, and data collection. Later studies emulated its approach model.

Atrocities Committed in the Name of Science

The clinical trial history is full of examples of abuse and unethical experimentation on people without their knowledge or consent. Some of the most atrocious acts committed against humanity in the name of science are:

• The Tuskegee Syphilis Study

• The Nazi Experiments

• The Guatemala experiments

These and many other examples of unethical approaches in clinical study prioritized scientific progress over ethics and humanity, accounting for the need to introduce stricter clinical practice regulations.

Clinical Trial Ethics and Regulations

As a response to the unethical conduct of clinical research throughout history, an ethical and regulatory framework was set post-World War II. Some of the codes and regulations guiding clinical research are:

• The Nuremberg Code
• The Helsinki Declaration
• The Belmont Report
• CIOMS’ Guidelines for Health-Related Research Involving Humans
• ICH’s Good Clinical Practice
• The U.S. Common Rule

To be ethically and legally viable, each clinical research has to abide by the following principles:

1. Scientific validity
2. Social and clinical value
3. Informed consent
4. Fair subject selection
5. Independent review
6. Respect for potential and enrolled subjects
7. Favorable risk-benefit ratio

These ensure that clinical trials are safe throughout each phase for both the patients and healthy volunteers.

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