2023-05-21 01:00:41
- Currently, more than 400 thousand clinical trials are carried out in more than 200 countries.
- All clinical studies carried out in Mexico are regulated by Cofepris.
- Each study has a protocol that describes who can participate, which is known as eligibility criteria.
More than 270 years ago, the Scottish physician James Lind carried out the first clinical trials in history. They consisted of dividing the sailors suffering from scurvy into groups and trying different remedies with each of them. That was how he realized that vitamin C cured this deadly condition and that is why every May 20, the day these tests began, commemorates the International Day of Clinical Research.
Currently, clinical trials have to adhere to more rules and protocols, since the safety of volunteers is their priority. However, his goals are still very similar to what Lind had more than two centuries ago: check the safety and efficacy of treatments, whether drugs, vaccines or devices. In addition, now the number of studies is much higher, since there are more than 400,000 active studies in more than 200 countries, including Mexico.
“At this moment alone, Merck in Mexico has 88 active clinical studies in the country, in 271 sites with the participation of 1,256 patients, which makes us the second sponsor of clinical studies in the country,” said Michelle Argüelles, director of MSD Clinical Research in Mexico.
To commemorate this important day for modern medicine, the expert answers some of the most common questions about these studies and the way in which they are carried out.
What is a clinical study?
In a clinical study, participants or volunteers undergo specific tests, which can range from taking medications or receiving vaccines, to participating in a procedure or changing their lifestyle, for example, through a change in their diet. They can compare a new medical treatment with a standard one that is already available, with a placebo that contains no active ingredients, or with no intervention at all.
Who regulates clinical studies in Mexico?
In Mexico, thousands of clinical studies are carried out annually, which are regulated by the Federal Commission for the Protection against Sanitary Risks (Cofepris) and can be found on their website.
Who can participate?
Each study has a protocol that describes who can participate, which is known as eligibility criteria. Some studies look for participants who have a specific condition, others look for healthy participants, and some add a specific characteristic that they need participants to meet.
Diversity and inclusion within studies has become an increasingly relevant issue, since different people may have different reactions to the same intervention based on their age, gender, weight, race, ethnicity, geography, or other factors. This is why clinical studies are currently conducted at Merck in more than 50 countries around the world.
How is the participant protected?
Clinical studies follow the ethical principles of the Declaration of Helsinki and good clinical practices, where the safety and well-being of patients is paramount. In addition, each patient signs an informed consent voluntarily and freely, prior to her participation in, which explains, among other things, that she can revoke her participation at any time.
Also read:
First pediatric antiviral against Covid-19 begins clinical trials: Mexico is the only country in Latam to participate
Bad news! Vaccine against HIV stops its clinical trials due to low efficacy
8 legal foundations that regulate clinical trials in Mexico
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