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What is a clinical research study?

Clinical trials, also known as “clinical research studies”, help researchers determine the safety and effectiveness of new medications for their intended recipients.

Why participate in a clinical trial?

Volunteering for a clinical trial can be immensely helpful for both researchers and physicians. By doing so, you enable them to gain a better understanding of your illness and create a healthier future for people who suffer from the same or similar ailments. Participating in clinical trials not only provides hope but also gives you free access to new medications and treatments, as well as the chance to receive expert medical attention.

We rely on our study participants to provide us with the necessary feedback to ensure the safety and effectiveness of new medications and to understand any potential side effects. Research participants play a crucial role in the clinical trial process, and we appreciate your feedback and participation.

What are your areas of study?

We are currently focused on the following therapeutic areas:

  • NASH (MASH) – Non-Alcoholic Steatohepatitis
  • NAFLD (MAFLD) – Non-Alcoholic Fatty Liver Disease
  • Inflammatory Bowel Disease
  • Ulcerative Colitis
  • Crohn’s Disease
  • PBC – Primary Biliary Cirrhosis
  • PSC – Primary Sclerosing Cholangitis
  • Diabetes
  • Rheumatoid Arthritis
  • Obesity
  • Psoriasis

To determine your eligibility for a trial, please consult with your gastroenterologist or contact us directly.  

Are clinical trials safe?

We follow stringent governmental guidelines to safeguard those who choose to participate in our clinical trials. Before a prospective treatment reaches Florida Research Institute, it has already gone through lab and model studies conducted by doctors and health professionals in accordance with rules set by the FDA.  

Our foremost concern is the health and safety of our research participants. Your medical condition will be closely monitored by experienced research staff and physicians throughout the study. Participation in a clinical trial is voluntary; you may withdraw at any time.

How do clinical research studies work?

Before new medications become available to the public, they must undergo rigorous testing before being approved by the FDA. There are many stages before a drug can be approved including both lab and human testing. Our site conducts trials with patients who are suffering from specific gastrointestinal conditions to evaluate the overall safety and effectiveness of an investigational medication.

Throughout the study, our highly skilled clinical research team will see you regularly. We will check your current health and medical history, provide instructions about the trial, and carefully monitor your health while you participate in the research study.

What is Informed Consent?

Before participating in a clinical trial, you will go through a process called Informed Consent. This process makes sure that you understand the study, have all your questions answered, and learn about your rights as a volunteer. You will receive a document that details the study, such as its purpose, expected duration, tests that may occur as part of the research process, and the potential risks and benefits involved. This process is designed to help you make an informed decision about whether or not to participate in the study.

Who sponsors clinical trials?

Clinical trial sponsors may be institutions, pharmaceutical companies, federal agencies or other organizations that finance the trial, but are not involved directly in the research.

Who conducts a clinical research study?

Florida Research Institute is a dedicated research organization that is committed to advancing medical knowledge. Our research studies are led by a physician who is known as the Principal Investigator (PI). Our research team includes a Sub-Investigator, Clinical Research Coordinators (CRCs), technicians, monitors, and support staff. We are proud to have over 20 highly dedicated research team members working across our three locations.

What are my rights as a study volunteer?

Participants can withdraw from a clinical study at any time, regardless of the reason, even after signing the informed consent form. Additionally, you have the right to be informed about any new risks or findings that may arise during the study. If researchers discover the treatment is causing harm, you will be immediately notified and withdrawn from the study.

Do I need medical insurance to participate?

No. Health insurance is not required, nor is insurance information collected.

Is there any cost to participate?

No. All study-related procedures and investigational medications are provided to you at no charge.

Is there compensation for my participation?

Yes. Most trials offer compensation for time and travel expenses. This information will be provided before the trial begins.

How do I know if I am eligible to participate?

Each clinical trial has its own eligibility criteria, which can vary significantly. The criteria include factors such as age, gender, the type and stage of disease, and whether the patient has undergone specific treatments or has other health issues. These criteria are implemented to ensure that new approaches are tested on a similar group of people. They also serve as a safety measure. By excluding individuals for whom the potential medication’s known risks outweigh any possible benefits, the criteria help to mitigate any potential harm.

How do I know if participating in a research trial is right for me?

Our team evaluates every patient individually to determine their suitability for our clinical research study. Our research physicians work closely with your gastroenterologist to ensure that participating in the study is the right path for your medical care. After a thorough review of your medical history and lab work, one of our physicians will speak with you to help you decide if participating in the clinical trial is in your best interest.

What do the terms placebo, control group and randomization mean?

Control group: A group of study participants who don’t receive the treatment. This help researchers determine the effectiveness of the medication or treatment being tested. Comparing the results of the group receiving treatment with the control group helps rule out imagined and/or random effects of the medication/treatment.

Placebo: A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment’s effectiveness.

Randomization: When treatments are assigned to study participants by chance to avoid any bias.

Who should I contact for more information?

If you would like more information about participating in a clinical trial, please contact our office at (941) 727-7772, and a member of our research team will be happy to assist you.

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