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BLOG | Clinical trials; myths and truths

Despite the enormous difficulty of the moment, there is something positive about the COVID-19 pandemic: it has helped us become aware of our ability to join forces and solve complex problems through science. We already knew this, but it has become more relevant in the last year, when we have realized that our best weapons to fight the COVID-19 infection are decisions based on objective data.

Thus, we have seen how in less than a year we have vaccines available to prevent SARS-CoV-2 infection, which have been developed thanks to clinical trials.

Clinical trials are research studies that are carried out to develop medicines using the scientific method. This means that they begin by setting out a problem or question that we will try to solve through a series of experiments, during which data is collected that will later be analysed in order to answer our problem. The questions to be answered in clinical trials are often the safety, tolerability, or efficacy of a drug for a particular disease.

The regulations for clinical trials are drawn up by groups of scientists made up of biologists, doctors, pharmacists, statisticians, among others. These protocols are then carried out in non-human animal species and, if the findings are encouraging and no significant health risks are anticipated, they are applied to humans. Therefore, the participation of volunteers in clinical trials is essential for the development of new drugs.

More than 100,000 volunteers participated in the phase III clinical trials, called efficacy trials, of the 4 vaccines for COVID-19 infection approved today by the European Medicines Agency (EMA): Comirnaty (BioNTech-Pzifer), COVID-19 Vaccine Moderna, Vaxzevria (AstraZeneca) and COVID-19 Vaccine Janssen. Without their cooperation, we would not have vaccines against COVID-19.

In the same way, in addition to scientists who develop research protocols, we need the participation of volunteers in order to develop treatments for Alzheimer's disease. However, too many times we hear that these volunteers are “guinea pigs”: nothing could be further from the truth.

The truth is that the research protocols are designed considering a very strict regulation to accomplish with the highest levels of good clinical practice, since it is essential to safeguard the safety of the participants.

Additionally, these protocols are reviewed and approved by drug regulatory agencies and ethics committees. Thus, when we participate in a clinical trial, we can rest assured that a very strict and detailed monitoring of our health and well-being will be carried out, with high quality standards.

Besides the COVID-19 pandemic, we are experiencing another epidemic: Alzheimer's. That is why we need the collaboration of the general population to find effective treatments that delay or slow its progression, and in the not too distant future, weed out it.

The vision of Ace Alzheimer Center Barcelona is that one day Alzheimer's will be history, that is why we work to develop drugs that are beneficial for people with cognitive impairment. Our goal is to preserve what defines us as people: our memories.

Could you help us to achieve it?

Look what we do and how can you help us.

DR. CARLA ABDELNOUR

Deputy Head of the Clinical Trials Unit at Ace Alzheimer Center Barcelona

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