What is a clinical research study?

Clinical research studies, sometimes referred to as “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?

When you volunteer for a clinical trial, you help researchers and physicians learn more about your illness and create a promising, healthy future for those suffering from the same or similar ailments. Clinical trials offer many patients hope, possible access to new medications and treatments for no charge, as well as a chance to receive expert medical attention.  

We count on our study participants to provide us with the feedback needed to ensure the new medications are safe, effective and any potential side effects are understood. Research participants are an essential part of the clinical trial process and we value your feedback and participation

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 reach out to 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 throughout the study by experienced research staff and physicians. 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 go through 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, you will be seen regularly by our highly skilled clinical research team. We will check your current health and medical history, provide instructions about the trial and carefully monitor your health during your participation in the research study.

What is Informed Consent?

Informed Consent occurs before you participate in a trial to ensure you understand the study, have all your questions properly answered and learn about your rights as a study volunteer. You will be given a document that includes details about the study including its purpose, expected duration, tests that may occur as part of the research process, risks and potential benefits. This process helps you decide whether to become involved in a 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?

At Florida Research Institute, our studies are led by a physician known as the Principal Investigator. The rest of our team includes a Sub-Investigator, Clinical Research Coordinators (CRCs), techs, monitors and support staff. We have more than 20 dedicated research team members at our two locations.

What are my rights as a study volunteer?

You can withdraw from a clinical study at any time and for any reason, even after signing the informed consent form. You also have the right to learn about new risks or findings that emerge throughout the study. If researchers learn that a treatment harms you, 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 provide compensation for your time and travel expenses. You will be provided this information before the trial begins.

How do I know if I am eligible to participate?

Eligibility criteria differs from trial to trial. The criteria include factors such as age, gender, the type and stage of disease, and whether the patient has had certain treatments or has other health problems. Eligibility criteria ensures that new approaches are tested on similar groups of people. These criteria also are a safety measure; they ensure a trial excludes any people for whom the potential medication’s known risks outweigh any possible benefits.

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

We evaluate each patient individually to ensure you are a qualified candidate. Our research physicians will collaborate with your gastroenterologist to make sure a clinical research study is the right path for your medical care. After a thorough review of your medical history and an evaluation of your lab work, one of our physicians will speak with you to help you decide if a trials 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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