2023-05-06 06:56:59
In Puerto Rico, more than 750 clinical studies have been carried out in different therapeutic areas.
By: Valentina Diaz Ospina
The atopic dermatitis It is a chronic disease that can affect people at any stage of their lives. It is usually due to a combination of factors, such as genetics, exposure to allergens, and the environment.
Research clinics
Clinical research is essential for the progress of medicine and its importance lies in the ability to provide accurate and reliable information that improves people’s quality of life.
“Clinical research helps us to answer all our concerns, not only for us, but it also gives light on how we can treat diseases and how we can prevent them”, Dr. Maricelly Santiago, Researcher and health communicator.
Atopic dermatitis and clinical study
Dr. Santiago has pointed out that studies on atopic dermatitis have allowed us to understand the nature of the disease, including the origin of the acute and severe inflammatory episodes that occur.
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These studies have provided valuable information for evaluating new investigational molecules and determining their safety and efficacy in the treatment of the illness. Therefore, advances in the investigation of the atopic dermatitis are essential to develop new options for treatment and improve the quality of life of people suffering from this chronic disease.
How do you participate in a clinical study?
According to Dr. Santiago, in order to participate in a clinical study the patient must take into account if, the clinical study It is open and is requesting patients, then confirm if the patient meets the requirements for the study, yes, if the patient will sign an informed consent.
Read also: FDA extends approval of CIBINQO® for the treatment from atopic dermatitis in over 12 years
It should be noted that “clinical studies are highly controlled and regulated, before these studies go to a population they begin in a pre-clinical phase,” Dr. Santiago announced.
Phases of a clinical study
He clinical study is divided into four distinct phases, each with a specific goal to assess the safety and efficacy of a treatment or medication. Each phase is designed to measure and obtain accurate and reliable information.
Phase 1: focuses on evaluating the safety of treatment and determining the appropriate dose, and usually involves a small group of healthy or diseased volunteers.
Phase 2: focuses on determining the effectiveness of treatment in a larger group of patients with the disease, as well as further assess safety.
Phase 3: involves an even larger number of patients and aims to confirm the efficacy of the treatment and assess its long-term safety.
Phase 4: takes place following the treatment or drug has been approved and marketed, and the goal is to continue evaluating its safety and efficacy in a broader population.
It may also interest you: “Sleep disturbances affect between 50 to 80% of patients with atopic dermatitis“
Who guarantees the safety of these studies?
According to Dr. Santiago, “the studies have around four regulatory agencies, which are aware, analyzing each step of the clinical studyeach result and each data”.
Benefits of participating in a clinical study
Dr. Santiago explains that participating in these studies brings the benefits of having a treatment new before it hits the market, the patient helps advance science and take better care of the condition.
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