International clinical trials day

The international clinical trials day is celebrated every year on 20th May. Without a doubt, this day represents the perfect excuse to remember the extraordinary importance of this activity for the advancement of science in general and, of course, to contribute to better health care opportunities.

Why celebrate the International Clinical Trial Day?

The idea for celebrating of international clinical trial day was developed in the 18th century British physician James Lind who, while sailing on the Salisbury ship between 1746 and 1747, was able to observe the devastating effects of scurvy on the crew.

In order to evaluate the effect of different treatments, he divided the sailors into several groups and administered different medicines to them. By verifying the positive evolution of those who included citrus in their diet, he was able to confirm the helpful effects of vitamin C in the treatment of scurvy.

Even in such precarious conditions, this moment can be considered as the first experiment of this type in which a certain systematization was applied, with a decisive employment of control groups. Therefore, this is often described as the first “clinical trial” in history.

Since the study began on May 20th 1747, this date serves to commemorate the prominent role that clinical trials play in our daily lives every year.

The commemoration of the international clinical trials day in Europe 

From a European perspective, the main initiative to commemorate the international clinical trials day comes from ECRIN (European Clinical Research Infrastructure Network).

Each year, this European network develops various initiatives around clinical trials, which typically include expert meetings and conferences that are open to the public.

For instance, in the year marked by the pandemic, the event focused on the analysis of the so-called platform trials, with special reference to their role in the European response to COVID-19.

Clinical trials are in good health in Europe. In fact, it is estimated that in the EU / EEA, approximately 4,000 clinical trials are authorized each year.

The outbreak of the COVID-19 health crisis confirmed this notable trend. Undoubtedly and as part of observations facilitated by the ongoing efforts related to the pandemic, this has a direct impact on improving treatments. In this way, from the first moments until today, the improvement in the therapeutic response to COVID-19 patients is more than evident.

Of course, the current unavoidable relevance of the recent pandemic should not make us forget all the other clinical trials that continue to be carried out in the most diverse areas.

Clinical trials and their regulation

During the international clinical trials day, it is interesting to remember current legislation efforts around this matter in Europe.

In this way, the fundamental norm in relation to this type of trial is the Clinical Trials Regulation EU No 536/2014, which aims at harmonizing assessment and supervision processes in the European continent.

Without a doubt, this legislation has promoted enormous advances in this field, a norm that has been then adapted to the different countries’ national legislatory codes.

What are the phases of a clinical trial?

In a very succinct way, it’s possible to summarize the fundamental stages of any clinical trial into the following four phases:

• Phase 1. It focuses on evaluating the safety of new treatments or medications, checking their toxicity, the necessary dosages, etc. 
• Phase 2. In this second stage, the trial focuses on carrying out a first verification of the efficacy of the medication or treatment. In order to do this, the range of tested patients is increased, and a careful evaluation of their responses to the treatment is carried out.
• Phase 3. The analysis is expanded again, testing the drug in a higher number of patients that are affected by the pathology. The evaluation is aimed both at analyzing safety and efficacy parameters, before proceeding to the drug’s commercialization.
• Phase 4. This stage takes place when the drug has been authorized for distribution and marketing efforts. Therefore, the tests focus on detecting problems in large-scale safety, adverse effects and, of course, continue to check the efficacy of the drug in the long term.

In short, the international clinical trials day represents a perfect occasion to appreciate the tireless work of all the people who are part of this field. All in all, without the dedication of clinical researchers, analysts, and all other professionals working in this sector, the great therapeutic advances that we have witnessed over the last few decades would not be possible.