We wouldn't have modern medicine without our clinical research history. These discoveries have brought us the many drugs and therapies used in health care, from over-the-counter cold medicine to advanced gene therapies for cancer.
Every day, researchers and volunteers write the next chapters in clinical trials history. If you've ever thought about becoming one of those volunteers, read on. This is the story you'll be joining.
What Is a Clinical Trial?
A clinical trial is a research study that tests the safety and effectiveness of a particular drug or therapy. The goal is to learn whether the treatment is more or less effective than what doctors already have.
Clinical trials follow a strict process with four key phases. Scientists must complete each stage before moving on to the next. The process is there to protect study volunteers and ensure scientists learn what they need to know.
Modern clinical trials involve cutting-edge medicines and devices. It's easy to think of the process as a modern invention, but clinical research history dates back further than you might imagine.
An Ancient Clinical Trial
When do you think the first clinical trial took place? You might guess the 16th or 17th century — a reasonable assumption, but you'd be off by a few thousand years.
Scientists believe the first record of an early "clinical trial" happened in the 500s B.C. The researcher was not a doctor or scientist, however. Instead, he was the Biblical military leader King Nebuchadnezzar of Babylon.
Nebuchadnezzar believed a diet of meat and wine would keep his people strong and ready to fight. So he ordered all of Babylon to eat only those two things, but a few young vegetarians refused. The king allowed the young people to eat beans and water for 10 days.
The vegetarians ended the 10 days in better health than the meat-eaters, so Nebuchadnezzar allowed them to keep eating their beans.
Even today, scientists study the effects of food on different health conditions. But when did Western medicine start investigating medicines?
Early Experimental Medicine
When scientists talk about the first trial of a new medication, they often mention the French military surgeon Ambroise Paré. He conducted the first modern clinical trial by accident when he ran out of necessary treatment.
In the 16th century, doctors used a boiling oil mixture to dress battle wounds. Unfortunately, Paré didn't have enough oil, so he created an alternative from egg yolk, rose oil, and turpentine. He didn't think it would work, but he had nothing else.
To his surprise, the soldiers who received the egg yolk mixture did well. They slept soundly and had little pain the next day. However, those he treated with oil had terrible pain and swelling.
The results changed how Paré treated gunshot wounds, and Paré became the father of the medical experiment.
The Scurvy Trial
Paré introduced several discoveries to medical care, but experiments didn't become commonplace for about 200 more years.
In the middle of the 18th century, scientific questioning became more popular. Physician James Lind was working as a ship's sailor, and many of his patients had scurvy.
Scurvy is a disease that causes severe weakness, joint and leg pain, gum disease, bleeding, and bruising. Doctors now know it develops when someone doesn't get enough vitamin C, but it was a mystery in Lind's day.
Lind took 12 patients with scurvy and sorted them into six groups of two sailors each. He gave each pair a different treatment. One pair received daily doses of oranges and lemons. Others received traditional remedies like vinegar, mustard, or garlic.
The citrus fruits were the clear winner. Lind wasn't sure why since doctors at the time didn't have a complete understanding of vitamins. Still, his process went down in history as one of the first controlled experiments and continues to have a major influence on clinical trials to this day.
Did you know that James Lind’s experiment with citrus fruits is the major reason our parent company is called Yuzu Labs? Yup, Yuzu is a citrus fruit of East Asia origin. And, in keeping with James’ vision, we remain committed to advancing research all over the world.
Blinding and Randomization
As the scientific process developed, experts realized they needed to make clinical trials more objective.
One breakthrough happened in 1943 when scientists were studying a treatment for the common cold. To ensure they recorded only "true" reactions, neither doctors nor patients knew who received the medication and who received a "dummy" solution.
Unfortunately, the medicine didn't work, but the experiment proved the importance of knowing what medication did—not what people thought it would do.
A few years later, scientists took another step toward making clinical trials more objective. To evaluate a treatment for tuberculosis, they randomly assigned the medication versus bed rest alone instead of alternating one versus the other.
Only the medical officer in charge of the study knew which patients had which treatment plan. The medicine worked but had some adverse effects, and doctors realized how important it was to get unbiased results.
As clinical trials became more widespread, scientists worldwide realized the need for ethical and legal norms. The first official action on the topic was the Nuremberg Code of the late 1940s.
The Nuremberg Code established that participants must knowingly consent to be part of a clinical study. In addition, it forbids verbal or physical force and requires that volunteers understand what would happen in the trial.
In 1962, the U.S. made informed consent the law with the Kefauver-Harris Drug Amendments. These amendments also played a significant role in requiring responsible and thorough clinical trials for all new drugs.
The next global development was the Declaration of Helsinki, first released in 1964. The Declaration established ethical principles for human subjects in medical research. Doctors continue to develop and update the Declaration to reflect new knowledge and social norms.
Clinical Trials Today
Today's clinical trials are complex affairs that involve dozens of skilled, committed professionals. StudyPages is proud to be a part of this process by helping research teams engage and recruit trial participants.
Volunteer participants play a crucial role in developing new medical treatments and saving lives. For example, did you know that over the past 40 years, cancer trials alone have provided patients with more than 14 million life years?