International Clinical Trials Day Date in the current year: May 20, 2024

Clinical trials are held to determine the efficacy and safety of new medications, devices, diagnostic products, and treatment regimes. Without successful clinical trials, a drug cannot be approved by a pharmaceutical regulatory agency. Only one-tenth of all drugs that undergo clinical trials eventually get approved.

The main difference between preclinical and clinical trials is that preclinical tests are performed in vitro and on animals, whereas clinical trials rely on voluntary human participants. It is impossible to develop a new drug and evaluate its safety and efficacy without clinical trials because some drug properties cannot be studied outside the human body.

Clinical trials of new drugs commonly consist of four or five phases, phase 0/I through phase IV. Participants are typically divided into two groups: the treatment groups receives the drug and the control group receives placebo. A drug is most likely to be approved if it successfully passes phase III; phase IV is carried out to assess risks, benefits, and optimal use of the newly approved drug.

International Clinical Trials Day is observed on May 20 to commemorate the first documented proper clinical trial that was conducted by Scottish physician James Lind in 1747. While serving as a surgeon in the Royal Navy, Lind became concerned with outbreaks of scurvy among sailors. Some physicians had suggested the use of citrus fruit as a cure for the disease, and Lind decided to conduct a systematic experiment to test the hypothesis.

Lind divided a dozen sailors affected by scurvy into six groups of two. They all were given the same food, but, additionally, group 1 received cider, group 2 elixir of vitriol, group 3 vinegar, group 4 seawater, group 5 oranges and lemons, and group 6 spicy paste and barley water. After six days, one sailor from group 5 was fit for duty and the other was on his way to recovery. Apart from that, only group 1 showed some positive effect, but cider wasn’t enough to treat the patients.

Unfortunately, Lind’s experiment and subsequent work entitled A Treatise on the Scurvy were virtually ignored, and it took the Royal Navy several decades to start issuing lemon juice as a daily ration to prevent scurvy. Nevertheless, it was this experiment that paved the way for modern clinical trials because it was systematic, reported, and controlled.

International Clinical Trials Day was created to connect clinical research professionals, research organizations, patient organizations, ethics and regulatory bodies, funders, and other stakeholders from different countries, as well as to educate the general public about clinical trials to increase the likelihood of participation and help clinical trial programs find enough participants.