FAQ


What is a clinical research study?

Clinical research studies, sometimes called “clinical trials,” help researchers test whether a potential new medication is effective and safe for those it is intended to help.

Why participate in a clinical trial?

Volunteering for a clinical trial can help researchers and physicians gain valuable insights into your illness. By participating in a clinical trial, you can help create a brighter future for individuals suffering from similar ailments. Clinical trials provide patients with a great opportunity to gain access to new medications and treatments at no cost, as well as receive expert medical attention.

Your feedback and participation are critical to ensuring the safety and efficacy of new medications and understanding any potential side effects. As a research participant, you play an essential role in the clinical trial process, and we appreciate your contribution.

What are your areas of study?

We are currently focused on the following therapeutic areas:

  • NASH – 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 take great care to ensure the safety of the individuals who participate in our clinical trials, following strict guidelines set forth by the government. All potential treatments undergo rigorous testing in labs and with models before they ever reach the Florida Research Institute, adhering to FDA regulations.

At Florida Research Institute, the health and well-being of our research participants is our top priority. Experienced research staff and physicians will closely monitor your medical condition throughout the study. Remember, participation in our clinical trials is entirely voluntary, and you are free to withdraw at any time.

How do clinical research studies work?

New medications have to go through rigorous testing to get approval from the FDA before they can be released to the public. This testing involves several stages, including lab testing and clinical trials on humans. Florida Research Institute conducts clinical trials involving patients suffering from specific gastrointestinal conditions to evaluate the safety and effectiveness of investigational medications.

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

What is Informed Consent?

Before participating in a clinical trial, Informed Consent must be obtained to ensure that you fully understand the study. This process involves having all your questions answered, learning about your rights as a study participant, and receiving a document that outlines important details about the research. This document includes information about the study’s purpose, expected duration, any tests that may be conducted as part of the research process, as well as potential risks and benefits.

This process aims to provide you with all the necessary information to make an informed decision about your participation 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?

The Florida Research Institute is led by a physician known as the Principal Investigator (PI). Along with the PI, our team consists of a Sub-Investigator, Clinical Research Coordinators (CRCs), technicians, monitors, and support staff. We have a team of more than 20 dedicated research members spread across our three locations.

What are my rights as a study volunteer?

Participants in a clinical study have the right to withdraw at any given time and for any reason, even after completing the informed consent form. Furthermore, they have the right to be informed about any new risks or findings that may emerge throughout the study. If researchers discover that a particular treatment is causing harm, they are obliged to immediately inform the participant and withdraw them 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 will be provided to you at no cost.

Is there compensation for my participation?

Yes. Before the trial begins, you will be provided with information regarding reimbursement for your time and travel expenses.

How do I know if I am eligible to participate?

The eligibility criteria for clinical trials can vary from trial to trial and may include different factors, such as a patient’s age, gender, the type and stage of their disease, and any prior treatments or health issues they have had. These criteria are put in place to ensure that new treatments are tested on similar groups of people and to serve as a safety measure.

Trials must exclude individuals who may be at risk for harm or for whom the potential risks of the medication outweigh the potential benefits.

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

Our research team evaluates each patient individually to ensure they are a qualified candidate for a clinical research study. Our research physicians work closely with your gastroenterologist to determine if a trial is the right path for your medical care. After thoroughly reviewing your medical history and lab work, one of our physicians will speak with you to help you decide if participating in a 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 helps 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’re interested in participating in a clinical trial, please contact our office at 941.727.7772, and a member of our research team will assist you.

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