Published on Saturday May 20, 2023
Happy Clinical Trials Day!
Clinical Trials Day arrives each year on May 20 as a joyous opportunity for the clinical research community to pause for reflection, recognition, and admiration for all that has been accomplished thanks to clinical trials and the people behind them. New medicines, therapies, devices. Healthier, longer and happier lives.
Smooth Drug Development thanks pharmaceutical, biotechnology, medical device, CRO and laboratory companies for their work on behalf of human health. We thank patients and their families for working with drug developers to bring safe and effective medicines to market. We thank regulatory agencies for overseeing the entire drug development process. We personally thank our employees for their contribution to the clinical trial process.
Smooth Drug Development, a full-service CRO, are proud to be responsible for the development of some important medicines for unmet medical needs in several countries.
Let us remember important milestones in the clinical trials industry.
Clinical Trials Day is celebrated worldwide in May to commemorate the day, May 20, 1774, when James Lind, a ship's surgeon in the British Royal Navy, began what is often considered the first randomized clinical trial (in this case, to study the effects of various treatments on scurvy in sailors).
Lind's trial included twelve sailors with scurvy "as similar as I could have them," housed in the same quarters (the forehold), and given the same basic diet. His report thus illustrates his awareness of the need to guard against selection bias and shows how he attempted to hold constant potential confounding factors - clinical condition, environment, and basic diet.
Without specifying the allocation method he used, Lind assigned two men to each of six different daily treatments for a period of fourteen days. The six treatments were: 1.1 liters of cider; twenty-five milliliters of elixir vitriol (diluted sulfuric acid); 18 milliliters of vinegar three times a day before meals; a pint of sea water; two oranges and a lemon, continued for only six days (when the supply was exhausted); and a medicinal paste of garlic, mustard seed, dried radish root, and gum myrrh. The most sudden and visible benefits were seen from the use of oranges and lemons.
It took another century for another important milestone in the history of modern clinical trials to emerge: the placebo. The word placebo first appeared in medical literature in the early 1800s.1 Hooper's Medical Dictionary of 1811 defined it as "an epithet given to any medicine which is more calculated to please than to benefit the patient. However, it was not until 1863 that American physician Austin Flint designed the first clinical trial to compare a placebo with an active treatment. He treated 13 patients suffering from rheumatism with an herbal extract recommended in place of an established remedy. In 1886, Flint described the trial in his book A Treatise on the Principles and Practice of Medicine. "This was given regularly and became known in my wards as the 'placebo remedy' for rheumatism. The favorable course of the cases was such as to secure for the remedy in general the entire confidence of the patients".
The first double-blind controlled trial - patulin for the common cold - took place in 1943.
The Medical Research Council (MRC) UK conducted a trial in 1943-4 to investigate patulin treatment (an extract of Penicillium patulinum) for the common cold. The trial was rigorously controlled by keeping the doctor and patient blinded to the treatment. Treatment allocation was done by alternation. A nurse administered the treatment in a separate room on a strict rotation. The nurse filed the record counterfoil separately and removed the code label for the appropriate bottle before asking the patient to see the physician.
While randomization was introduced as a concept in 1923, it wasn't until 1946 that the first randomized, controlled clinical trial was conducted. The MRC conducted a streptomycin trial that was highly systematic, using allocation concealment and objective monitoring approaches to improve the quality of the data collected. This strategy, although a departure from current norms, quickly became the framework for future clinical trials.
During World War II, the Nazis conducted horrific, unscientific, and non-consensual experiments on prisoners. While the Nuremberg Trials were underway, a separate "Doctor's Trial" was held specifically for the doctors who performed these experiments.
Dr. Leo Alexander outlined six points - later expanded to ten - that defined true medical research and gave the War Crimes Tribunal a basis for judging the actions of the physicians on trial regarding their treatment of prisoner human subjects. These points became known as the Nuremberg Code and created an official, widely accepted set of guidelines for what medical research should and shouldn't include. Some of the points include voluntary and informed consent, the ability for patients to withdraw from studies, and no unnecessary physical or mental harm.
After the Second World War, thousands of experiments were carried out and many guidelines were introduced.
Many important achievements have been made since then. But we would like to mention another important milestone. It is the COVID-19 pandemic which brought a lot of challanged of global efforts to cope with the global impact of the disease. We will use many of the solutions invented during the pandemic in our future trials.