Any vaccine, drug or health device that is available in the past, before being approved by the regulatory authorities of a country or region, goes through a series of stages of scientific studies that allow various parameters to be verified. “The clinical studies They are medical investigations in which medications, treatments or medical devices are evaluated, with the aim of diagnosing their effectiveness and safety. They require the voluntary participation of both healthy and sick people and their purpose is to evaluate new treatments, contribute to the diagnosis of diseases and find ways of prevention,” explains the National Authority of Medicines, Food and Medical Technology, ANMAT.
And he continues: “They provide solid scientific evidence that forms the basis of therapeutic decisions, contributes to improving the health care of the population and improving their quality of life.”
In fact, the ANMAT website lists the clinical studies approved in Argentina, along with their local sponsor, what phase they are in (from 1 to 3) and a very brief summary of the conditions. In total, and Taking from the years 2018 to June 2024, there are 1,245 clinical trials listed.
But find clinical trials in other places around the world and know if a person with a certain disease is able to participate in any of them it’s not simple. “After working for 15 years as a medical researcher and co-founding with two other doctors an institution dedicated to clinical trials, life put me “on the other side of the desk”: approximately a decade ago I was diagnosed with a very rare disease, an EPOF (rare disease) called Lewis-Sumner syndromea demilienizing polyneuropathy. The first thing I did was deny that anything was wrong with me, I tried to think that it was nothing. Over time, I learned to accept what I was dealt, get up and go through the illness,” he describes. Georgina Sposetti.
Lewis-Sumner syndrome is an autoimmune disorder that affects the nerves, responsible for transporting impulses to the muscles and allowing sensory stimuli to be felt, such as touch. The damage is caused by incorrect activation of the immune system against myelin, a substance that covers the nerves.
“I made all the necessary medical consultations but there was no cure or any treatment,” Sposetti recalls. What happened to this one Argentine doctor and researcher is that, in the absence of medication available for his illness, began looking for a clinical trial in which to participate. And he found himself experiencing firsthand what his patients experienced: the difficulty finding reliable and understandable information. Most of the information available was not only in English, but was difficult to access and impossible to understand for a person without medical training.
“As a researcher, I used to invite my patients to participate in clinical trials. One day, I had to be that patient who was looking in a trial for a treatment opportunity, a hope of finding that medication that would save me or at least improve my quality of life. There I realized that, even with my technical knowledge, with a master’s degree in research and knowing English, looking for a clinical trial was an impossible mission. And even more connect with the researcher. I felt that the disease had appeared for a reason and that there were many patients like me throughout Latin America without access to this information. At that moment An Essay for Me was born. Today is a platform that connects patients with medical researchers in 11 Latin American countriessomething like the Tinder of clinical trials,” summarizes the Argentine doctor, master in Clinical Pharmacological Research.
The UEPM site is the first search engine for clinical trials in Latin America in Spanish and Portuguese with information “in patient language.” On this platform, All open clinical research studies that are enrolling patients in Latin America are listed.authorized by regulatory entities and ethics committees. In addition to information related to the molecule under investigation, the research centers that carry out these investigations are also listed. In this way, patients can contact the researchers. A Trial for Me is completely free for both patients and medical researchers. In 2021 the specialized magazine The Lancet Oncology published an article about the site created by Sposetti.
News: What difficulties did you encounter in your search and what are you trying to solve with your development?
Georgina Sposetti: A clinical trial is an opportunity or at least hope for all patients who cannot find a solution with the available drugs. Nobody tells you that it will cure you because it is under investigation but it is one more alternative. They have an oncological disease, a rare disease or a more common one. From this need to turn a disease into an opportunity, Un Trial for Me (UEPM) was born, a platform that aims to provide simple, accessible and reliable information about clinical trials and connect patients with medical researchers.
Although I sometimes protest and get angry every time I have to go to the hospital to receive my medication, I am grateful: first, because I have medication that allowed me to lead an almost normal life in recent years; Second, because I am a privileged person who was able to access it. However, my disease is slowly progressing and I continue to look for clinical trials with new medications.
In countries like ours, clinical trials are often another alternative that many reject because they are unaware, because they are surrounded by myths, ideologies or simply due to lack of information. Decision makers should know that a clinical trial is an alternative that we must inform when it exists; and patients must exercise our autonomy to make decisions: without alternatives on the table we are being denied one of the principles of Ethics.
We must all work on access to already approved medications and also on access to clinical trials. My mission and that of An Essay for Me is to bring these opportunities closer and I hope many will join.
News: What is the experience of people from Argentina who find clinical trials? Have they told you about it?
Sposetti: Every month, more than 15 thousand people apply to participate in different clinical trials through our website. Our Community Assistance team, which works in 11 countries in Latin America, the Latin community in the United States and Spain, contacts approximately seven thousand per month, which are those who meet the main inclusion and exclusion criteria of the protocols and Contact medical researchers.
I have the case of a patient that I remember with great affection: her name is Elisa, she is from Mexico. She told how her life had changed since one day she found a post on Facebook about a clinical trial for her disease and today she is participating. And what she says is ‘I’m still suffering from my illness, but hope and opportunity are saving my life.’
Testimonials like this are repeated and it is very gratifying, because it is our mission as a company, to link patients with trials and give them new hope. There are thousands of beautiful stories that come to us and that keep me going with all this. Because there is also the difficult part of starting and running a company where 75 people work today.
News: And the reception by the laboratories and medical professionals who carry out the trials?
Sposetti: Talking openly about clinical trials was completely disruptive. And it still is, especially in Latin America, where until our arrival, in countries like Argentina, running campaigns on Social Networks talking about scientific research was unthinkable. But An Essay for Me showed that it can be done while respecting current regulations. This led the medical community to see us as a valuable and necessary link and today, the vast majority support our work. Everything they find on the networks about any research is approved by ethics committees and notified to regulatory entities.
So much so that we just launched An Essay for Me Oncoa hub in which primary oncology doctors They can search in a simple and very precise way for clinical trials for their patients and connect the clinical researcher to whom they want to refer them, or simply consult. There is a clear need for doctors to be able to access information simply and quickly about clinical research and have it available to provide alternatives to their patients within the office.
Phases of scientific investigations
Clinical trials are the last stage before a drug or medical device can apply for registration and enter the market.
First, studies are carried out with cell cultures (in vitro), then research with animals (in vivo) and if these tests yield positive results, a drug or medical device can be tested in humans. Each of these stages must also comply with established good practices in particular.
Clinical trials can only be initiated after researchers have conducted a study in laboratory animals to determine potential toxicity, to confirm that the drug or device has an acceptable safety profile, and after its efficacy has been demonstrated under ideal conditions.
Although the results of in vitro and animal tests are sometimes promising, it is not known whether the potential medical treatment is truly beneficial to patients until clinical research on the treatment is completed. And in fact, we can only talk about the effectiveness of a treatment once it is approved and used by the population in real conditions.
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