Question 1

What is a Clinical Trial?

Accepted Answer

A clinical trial is a research study conducted with human participants to evaluate the safety, efficacy, and side effects of medical interventions such as new drugs, treatments, or devices. The purpose of clinical trials is to gather essential data that can lead to the development of new medical treatments and improve existing ones. These trials follow a structured process that typically includes multiple phases:
1. Phase I: Focuses on testing a new drug or treatment in a small group of participants (20-100) to assess its safety, determine a safe dosage range, and identify any side effects.
2. Phase II: Involves a larger group of participants (100-300) to evaluate the efficacy of the drug or treatment and further assess its safety.
3. Phase III: Enrolls a large group of participants (1,000-3,000) to confirm the treatment’s effectiveness, monitor side effects, compare it to standard or existing treatments, and collect information to ensure safe usage.
4. Phase IV: Conducted after the drug or treatment has been approved and marketed, these studies gather additional information on the drug’s effectiveness and long-term safety in a broader population.
Clinical trials are designed and conducted following rigorous scientific and ethical guidelines to protect participants' health and rights. Data from these trials are crucial for regulatory approval and the development of new medical therapies.

Question 2

How a Clinical Trial Works

Accepted Answer

Participating in a research study is a valuable way to contribute to medical advancements and potentially benefit from new treatments. Here's what you can expect if you decide to join a study:

Overview of the Process:

1. Supervision by Healthcare Professionals Research studies are supervised by a team of qualified doctors, researchers, nurses, and other healthcare professionals who ensure your safety and the integrity of the study.
2. Initial Meeting and Discussion If you're interested in participating, you will first meet with a member of the study team. They will explain the study in detail, including its purpose, procedures, potential benefits, and risks. This is your opportunity to ask any questions you may have.
3. Informed Consent After the discussion, if you decide to proceed, you will be given an informed consent form to read and sign. This document outlines what you can expect during the study, such as:
    • Frequency of study visits
    • Procedures to be done
    • Potential benefits and risks

It's crucial to review this information thoroughly. If you have any questions, discuss them with the study doctor or coordinator. Only sign the form when you fully understand the details and are ready to participate.

4. Screening and Eligibility Once you've signed the informed consent, the study team will collect information to determine if you qualify for the study. This may involve: 
 • Reviewing your medical history 
 • Conducting a physical exam 
 • Drawing blood for specific tests

5. Enrollment and Participation f you meet the eligibility criteria, you will be officially enrolled in the study. Here’s what you can generally expect during your participation: 
 • Group Assignment: You may be assigned to a group that receives the medication being tested or to a placebo group (receiving an inactive product, like a sugar pill). 
 • Regular Visits: You'll need to attend scheduled study visits for monitoring and assessments. 
 • Health Monitoring: Your health will be closely monitored throughout the study to ensure your safety and gather necessary data.

6. Completion of Study Visits It's important to complete all your study visits and follow the instructions provided by the study team. This helps ensure the accuracy and reliability of the study results. 
By participating in a research study, you are playing a crucial role in advancing medical knowledge and potentially helping to develop new treatments that can benefit many others in the future. Your contribution is highly valued, and the study team is there to support you every step of the way.

Question 3

Why participate in a Clinical Trial?

Accepted Answer

Participating in a clinical trial offers several benefits, including:

1. Access to New Treatments: Participants may gain access to new therapies that are not yet available to the general public, potentially receiving cutting-edge treatment for their condition.
2. High-Quality Medical Care: Clinical trials often provide participants with close monitoring and care by a team of doctors, nurses, and other health professionals throughout the study.
3. Contributing to Medical Research: By participating in a clinical trial, individuals contribute to the advancement of medical science and the development of new treatments, which can benefit others with the same condition in the future.
4. Active Role in Health Care: Participants take an active role in their own health care, often learning more about their condition and the latest medical advancements.
5. Potential Health Benefits: Some participants may experience positive health outcomes from the treatment being tested, which could improve their quality of life or health condition.
6. Compensation: Many clinical trials offer financial compensation for time and travel, which can be an added benefit for participants.
7. Enhanced Follow-Up: Participants often receive thorough follow-up care and monitoring, which can help detect and manage any health issues early.

Question 4

Do I need medical insurance to participate in a trial?

Accepted Answer

No, medical insurance is not required. Eligible study participants will  receive study-related medical examinations and medications at no cost to  ensure their safety. Additionally, medical ethics committees oversee  research studies to guarantee proper treatment of all participants.

Question 5

Who is eligible to volunteer?

Accepted Answer

All research studies have  requirements which must be met in order to participate. These requirements may include your age, gender, medical history, and/or current medication use, along with specific inclusion and exclusion criteria. If you interested in participating in a study, please fill our a contact form, or contact us at 239-800-3028 to see if you qualify.

Question 6

What are my rights as a volunteer?

Accepted Answer

As a participant in a research study, you have the right to withdraw  from the study at any time. You also have the right to receive any new  information related to the study and to ask questions at any time, with  the expectation of prompt and thorough answers.

Question 7

Patient Experience and Safety

Accepted Answer

Participating in a clinical trial at Renaissance Research and Medical Group involves receiving care from a team of dedicated medical professionals who specialize in various fields. Our highly skilled and passionate staff are united in their goal to advance medical research and develop new pharmaceutical treatments. Researchers,  doctors, and other healthcare professionals conduct research in  accordance with very strict rules set by the Food and Drug  Administration (FDA). The FDA created these rules to protect the safety  of the research subjects.

Partnering with esteemed sponsors like Sanofi, Lilly, and Pfizer, we ensure professional intervention and support at every stage of the trial, providing participants with exceptional care and contributing to the future of medicine.

Question 8

Therapeutic Areas

Accepted Answer

We support a wide-range of therapeutic areas with specialties in:

• Dermatology
 • Gastroenterology
 • Hematology
 • Immunology
 • Infectious Diseases
 • Nutrition and Weight Loss
 • Obstetrics/Gynecology (Women’s Health)
 • Psychiatry/Psychology
 • Vaccines

Become a Clinical Study Volunteer