Frequently Asked Questions About Clinical Research

Frequently Asked Questions About Clinical ResearchDo I need medical insurance to participate in clinical research?
No medical insurance is necessary to participate in clinical studies. If accepted for a trial, participants are provided study medication and are closely monitored by the research site’s medical doctors and staff.

Do I get compensation if I join a study?
Eligible participants will receive compensation for studies. Compensation varies from study to study.

Who administers the studies?
A board certified medical doctor and highly trained clinical research coordinators work with you throughout the study.

Are clinical trials safe?
The Food and Drug Administration (FDA) has strict guidelines and regulations that help ensure the safety of clinical trials. According to the FDA, “Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people and new ways to improve health.” Research subjects are closely followed with blood work, physical exams, and other testing relevant to the study.

What are clinical trial phases?
Clinical trials are conducted in a series of steps, called phases – each phase is designed to answer a separate research question.  Meridien Research conducts primarily Phase III and IV clinical trials.

• Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

• Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

• Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

• Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.

How long is a clinical trial?
The commitment to a clinical trial varies from a few weeks to up to several years. You will be told during your initial visit exactly what is expected of you during the trial, so you can make a decision about whether or not you want to continue with the screening process.

How often can I participate in a study?
You must take a 30 day break between studies.

Will I get a placebo or real medicine?
Some studies compare the medication being tested in one group against another group taking a placebo (a look-alike pill or tablet that has no active ingredient). You will be told if there is a placebo involved in the study you are considering enrolling in so you can make an informed decision about whether to enroll in the study.

Where can I find information on research sites in my area?
Meridien Research has five offices throughout the Tampa Bay area – Tampa, Lakeland (opening in May), St. Petersburg, Bradenton, and Brooksville.  Meridien Research has been conducting clinical trials for over 10 years and its medical doctors have worked in research for decades. Visit www.NewStudyInfo.com to see a list of all the studies at Meridien Research.   If you don’t see any studies that work for you, Meridien will add you to their database. When Meridien gets a new study, they do a database search and contact you to see if you’re interested.  New studies are added continually and Meridien knows months in advance what studies will be offered and will gladly put you on a waiting list and notify you when the study opens.

Which physician works at your Bradenton location?
Louis B. Chaykin, MD, is board certified in Internal Medicine and has over 15 years of experience in pharmaceutical research and has been a principal investigator with Meridien Research since 2008.   He has conducted more than 50 clinical trials and is an expert in diabetes.

What studies are you currently offering at your Bradenton location?
New studies open continually, so please contact our office for a complete list, but at this time we are recruiting patients for the following trials:  type 1 and type 2 diabetes, constipation caused by pain medication, women’s studies, cardiovascular disease (heart attack or stroke), diabetic foot pain, irritable bowel, low testosterone, constipation, high cholesterol, pain when walking (PAD), and gout.

Meridien Research
5700 SR 64 East, Bradenton, FL 34208
941-756-8680