Palestra - Voluntários UNIFAG

Summary

The video introduces Unifag, a research unit at the University of São Francisco, focused on conducting clinical studies for registering generic and similar medications. It explains the importance of participation in these studies, which help ensure safe, effective, and affordable treatments for the Brazilian population. Participants must meet specific health and age criteria, and undergo a thorough health evaluation before joining. The study process involves multiple stays, medical assessments, and medication administration, with a compensation provided. The video emphasizes the significance of this research in improving public health policies and the development of medicines in Brazil.

Takeaways

• 😀 Unifag is a research unit of São Francisco University focused on clinical studies for registering generic and similar medicines.
• 😀 Unifag has been operating for over 20 years and contributes to public health policies, scientific development, and technological progress in Brazil.
• 😀 The National Health Surveillance Agency (ANVISA) regulates medicines and ensures their safety and efficacy, including generic and similar medicines.
• 😀 Unifag supports ANVISA by conducting clinical studies on medicines whose patents have expired, enabling their production as generics or similar medicines.
• 😀 Participation in studies helps develop safe and effective medications, making treatments more accessible to the Brazilian population.
• 😀 The recruitment process requires participants to be healthy individuals aged 18-55 with a BMI between 18.5 and 30.0 and a weight between 50 and 99 kg.
• 😀 Certain groups are excluded from participation, including smokers, users of banned drugs, and those with chronic health conditions like hypertension or diabetes.
• 😀 A health evaluation is required to ensure participants are fit for the study, including physical exams, laboratory tests, and consultations with doctors.
• 😀 Studies usually take place over two periods with hospital stays, varying from 24 to 36 hours, and include a cost assistance payment starting at R$1,000.
• 😀 Participants will be monitored during their stay, with regular checks on vital signs, heart conditions, and blood/urine tests, as well as meals and accommodation provided.
• 😀 The study process ensures safety with professional care, and volunteers must return for follow-up evaluations before receiving their compensation.

Q & A

What is Unifag, and what role does it play in clinical research?

Unifag is a research unit at the University of São Francisco, certified by Anvisa (National Health Surveillance Agency). It conducts clinical studies to support the registration of generic and similar medications, contributing to public health policies and the development of science and technology in Brazil.

What is Anvisa, and why is it important in the context of clinical research?

Anvisa is the National Health Surveillance Agency of Brazil, linked to the Ministry of Health. It regulates and ensures the safety and effectiveness of products like medications, food, cosmetics, and pesticides. It sets strict rules for drug registration, ensuring public health protection.

What is the purpose of clinical studies conducted at Unifag?

The studies conducted at Unifag aim to evaluate and support the registration of generic and similar medications. These medications, once patented, can be manufactured by other pharmaceutical companies to offer affordable alternatives to the public.

Who is eligible to participate in the studies at Unifag?

Eligible participants are healthy individuals aged 18-55 years, weighing between 50-99 kg, with a body mass index (BMI) between 18.5 and 30.0. Participants must not be smokers, drug users, or those on continuous medications such as antihypertensive or antidiabetic drugs.

What health factors are considered before allowing someone to participate in the study?

Participants must pass a health evaluation, including an assessment of their medical history, physical exam, and lab tests. Individuals with a history of certain surgeries or those who are pregnant, breastfeeding, or recently donated blood (within the past 3 months) are excluded from participation.

What are the steps involved in the recruitment and evaluation process for participants?

The recruitment process starts with an informative talk. Interested participants must sign a recruitment agreement and undergo an initial health assessment, including weight, height, blood pressure, and an electrocardiogram. If they pass, further lab tests (blood and urine) are conducted to ensure their suitability for participation.

How are the clinical studies structured at Unifag?

Studies are typically conducted in two periods, with a time gap of 7 to 28 days between them. Each period involves hospitalization for 24 to 36 hours, during which participants receive medication, undergo regular health assessments, and provide blood samples as per the study protocol.

What should participants bring or expect during their stay at Unifag for the study?

Participants can bring personal items like cell phones, tablets, and laptops, along with their chargers. They will also receive appropriate clothing for the study and have access to Wi-Fi. Their meals will be provided, and accommodations will include bed linens and a comfortable environment.

What are the details of the compensation provided to participants?

Participants receive a financial compensation for their time and participation, which typically starts at R$ 1,000. The exact amount depends on the specific study and the number of hospitalizations required.

How does Unifag ensure the safety and well-being of participants during the study?

Unifag prioritizes participants' safety by conducting thorough health assessments before and during the study. This includes regular monitoring of vital signs, blood samples, and medical examinations. Participants are also provided with comfortable accommodations and meals to ensure their well-being throughout the study.