Frequently Asked Questions


Who are we?

As a premier clinical research organization, we have conducted more than 1,000 clinical trials over 20 years and have worldwide recognition for providing patients access to cutting edge medical research. If you have a medical issue and want a research solution, or if you are a healthy volunteer, come visit our center and learn more. One of our experts will be happy to evaluate you.



What are Clinical Trials?

Clinical trials are controlled research studies that monitor the safety and effectiveness of medications or devices for human use. Clinical trials involve many different aspects of research. Some trials test new, cutting edge medications, while others test new combinations or applications of medications that have not been previously approved. All trials, however, require the participation of volunteers in order to advance medicine as a whole. The volunteers are medical heroes!



How do Patients Benefit from Participating in Clinical Trials?

There are numerous benefits from participating in a clinical trial. Many of our volunteers appreciate the access to cutting edge treatments. Others participate to receive potentially expensive study medications and treatments at no cost, as well as compensation for their time and travel. Lastly, our patients love the sense of community and civic service they feel knowing that their participation contributed to advancement of medicine. The Center for Information & Study on Clinical Research Participation (CISCRP) found that 95% of participants who completed a clinical trial were interested in participating in another!



Are Clinical Trials Safe?

Many people who have not previously participated in a clinical trial are concerned about the safety of participating. The safety of our volunteers is our number one concern! Unlike most situations in life, while participating in a clinical trial you have constant access to medical care and qualified staff who monitor your wellbeing with meticulous attention to detail. Our doctors, nurses, and study coordinators will support you throughout the clinical trial process.

All pharmaceutical research goes through an extensive preclinical testing process before it ever reaches human patients to make sure it is as safe and effective as possible. Every clinical trial in the US must pass rigorous regulations and be monitored by an Institutional Review Board (IRB) to ensure the risks of the trial are as minimal as possible and worthy of any possible benefits to the participant.



The Guinea Pig Myth

A common misconception about clinical trials is that participants are research "guinea pigs." This statement could not be further from the truth. Historically guinea pigs were used in research because of similarities they share with humans. However, guinea pigs do not have the ability to understand what a clinical trial involves and sign an informed consent. An informed consent form is a document that describes the goal of the study, what risk is involved, the possible benefits to the patient, and potential patient compensation. As mentioned above, all clinical trials are monitored by IRBs that ensure the tirals are ethical and as safe as possible for human participation. Research volunteers are not guinea pigs. However, participants are just as important to future medical breakthroughs as guinea pigs were to the discoveries of vitamin C and the tuberculosis vaccine!



The Phases of a Clinical Trial

Clinical trials are divided into different states called phases. The earlies phase trials look at whether a drug is safe or the side effects it causes. Later phase trials aim to test whether the new treatment is better than existing treatments.

  • Phase I involves the testing of IP's (investigational products) for safety in humans for the first time. Phase I trials typically involve a small number of either healthy volunteers or people with the disease/condition.
  • Phase II trials continue to monitor the safety of the IP and determine its effective dose. These trials involve several hundred volunteers.
  • Phase III trials measure the effectiveness of the IP to treat a designated condition. These trials are large scale and involve hundreds to thousands of volunteers.
  • Phase IV trials are often required by the FDA and are designed to measure long term safety and efficacy of IP's after they are approved.


Who pays for this research?

Sponsors such as pharmaceutical companies, governments and foundations fund medical research through study grants. The grant provides the funding to conduct the study at local research sites, so you don't pay a thing. In fact, we don't even ask for your insurance information.



How long do the programs last?

Depending on the type of research, studies can last from a few weeks to several years. Each program is designed to collect specific information, but volunteers will know before enrollment how long the study is expected to last and exactly how many visits to the research site will be required.



How do I know if I am qualified?

Because each research program is unique and has specific enrollment criteria, the best way to find out if you qualify for a clinical research study is to either call us or come in for a free evaluation. Whether you have a medical issue and want to explore research solutions, or you are a healthy volunteer, come visit one of our research sites and find out more. There is never an obligation, and one of our experts will be happy serve you.



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Our Specialists


Mitchell Rothstein, MD

Dr. Mitchell Rothstein is a Clinical Research Investigator at our Fleming Island research site and he has been with us for 5 years now. In February 2017, we are happy to say that Dr. Rothstein also became our new Phase 1 Medical Director at our Jacksonville University research site. We consider him an all-star at ENCORE Research Group, not only did he perform the first endobronchial stent in Jacksonville, but he also lettered in gymnastics in college. Which is probably why he handles working at two locations with ease.

In his free time, he collects animation art, especially the work of Chuck Jones, the famous Looney Tunes animator. Dr. Rothstein is a major sports fan. He loves watching mixed martial arts and is an Olympics sports addict. He is also a fan of the Jacksonville Jaguars, the New York Mets and the Jacksonville Jumbo Shrimp, our minor-league baseball team in Jacksonville.

While Dr. Rothstein has some downtime, he enjoys eating, he calls himself a ‘happy carnivore’! Some of his favorite TV shows to watch are: Fargo, Billions, Jeopardy, and Snapped. All in all, we’re glad we have Dr. Rothstein as part of our ENCORE Research team and we’re excited to see what he accomplishes with us in the years to come. 

Alpa Patel, MD

Since 2008, Dr. Alpa Patel has been a team member at the Jacksonville Center for Clinical Research. Aside from her duties as a Clinical Investigator, she also works full time at Family Care Partners of Arlington.

Dr. Patel was born in London, but has called Florida her home for more than 20 years. She earned her Medical Degree from University of Florida and then she trained in Internal Medicine at Shands Hospital.  She is Board certified in Internal Medicine.

Although Dr. Patel is kept extremely busy by her medical practice and duties as a Clinical Investigator, she always makes time to raise awareness about clinical trials. Dr. Patel often hosts educational sessions at the clinic to shed light on what goes on in clinical trials and discuss new medications. However, her philanthropy knows no bounds as she has also been active in many community volunteer efforts including Habitat for Humanity, free health clinics and AIDS awareness education. In her downtime, she enjoys traveling, watching movies and sports, and spending time with her family.

Michael J. Koren, MD, FACC, FAPCR, CPI

Michael J. Koren, MD, is a practicing cardiologist and Chief Executive Officer at Jacksonville Center for Clinical Research, which conducts clinical trials at 8 locations in Florida. He received his medical degree cum laude at Harvard Medical School, and and completed his residency in internal medicine and fellowship in cardiology at NewYork Hospital/Memorial Sloan-Kettering Cancer Center/Cornell Medical Center.

Dr Koren is a fellow of the American College of Cardiology. He is also a fellow and president of the Academy of Physicians in Clinical Research and the current president of the regional chapter of the American Heart Association. As a principal investigator, Dr Koren has conducted more than 500 clinical trials on hypercholesterolemia, cardiovascular disease, and heart failure.

Dr Koren’s research has been published in peer-reviewed journals including Journal of the American College of Cardiology, Circulation, New England Journal of Medicine, and The Lancet. He is an editorial board member of Clinical Cardiology. He has lectured nationally and internationally on topics such as lipid-lowering therapy and preventive cardiology.

 

Andrea West

Andrea is a Clinical Research Coordinator at our University office and has been a VIP of the JCCR family for 14 years now. She obtained a bachelor’s degree in Zoology from the University of Florida and is an avid Florida Gators fan! She then went on to get her Master’s in Public Health at FIU.

Andrea loves to travel with Gerald, her husband of 17 years. “Traveling, pizza, cheese, and coffee, that’s all I need to survive” she says. Together they have traveled to Galapagos Islands, Barcelona, Paris, Costa Rica, Hawaii, Ecuador, many national parks, and British Columbia where she got unreasonably close to a mother grizzly bear and her cub. 

She has two adopted dogs from the humane society. Her favorite show is Outlander, and she hopes to read all 8 books in the series. She says “I love reading and hiking on vacation, maybe it’s time to take another trip!”

Amanda Elwood

At Encore Research Group we have many employees who work behind the scenes and never get to meet patients. Amanda Elwood is a prime example, as she is a Regulatory Specialist at our Jacksonville office handling regulatory compliance and lots of the paperwork it takes to get new studies started. She has been with us for two years now.

To say Amanda loves animals is an understatement, since she has three dogs and four cats. We have to agree with her when she says “It’s a lot of work, but the snuggling makes it worth it!”

Amanda was born in Puerto Rico and she loves Hispanic foods! Some of her favorites are tostones, empanadillas and picadillo.

She is obsessed with The Walking Dead and Game of Thrones. She also collects postcards from all of the places she visits. She spent a summer studying abroad and collected postcards from Switzerland, Amsterdam, France, and Italy.

Amber Devries

Amber has been at Jacksonville Center for Clinical Research for eight years and along the way she has acquired many hats. She is the assistant site manager, a clinical research coordinator, the office party planner, and a birthday card making committee of one.

Amber graduated with a degree in biology from Jacksonville University. While there, she played on the women's soccer team, and between games she met her husband Kyle, who pitched for the JU baseball team. She still gets such a kick out of soccer that she is currently coaching a girls team for a local high school.

If you think Amber isn’t occupied enough at work and play, she also stays busy with two active sons and a baby girl!

Lateshia Taylor

Lateshia Taylor is a research assistant at the JCCR university office and has been a member of our research family for ten years. She loves to travel and try new outdoor adventures with her son, Shumbae. And when she says adventures, she’s talking zip-lining, camping and river-rafting. Her favorite sport is football and she is a Jaguars fan, but as the mom of a busy six-year-old, she also appreciates quiet time reading and the occasional pampering pedicure or massage. 

While she tells us that she doesn’t really have a favorite food, she does warn us that she will NOT eat peas or beans. She hates peas and beans. 

Lateshia admits that her guilty pleasure is messy reality TV, but since she just moved into a new house, we doubt that she’ll have much time to indulge in that for a while. She will be occupied with decorating and arranging her new space – making a home sweet home.

Congratulations on your new adventure Lateshia!

Alex Hill

Since Spring of 2013, Alex has been a wonderful addition to our research family. He has been a Research Assistant at two Encore Research sites; starting at Fleming Island Center for Clinical Research and currently at Jacksonville Center for Clinical Research (University Blvd).

Alex is a man of many hobbies, some of which include: plant breeding "Nepeta cataria citriodora" (Citrus Cat Nip), lampworking, bead making, cycling, and gardening. In fact, Alex's garden is called Eir and is registered with the Florida Department of Agriculture and Consumer Services (FDACS) and he has formed an LLC (Limited Liability Company) named Lyfberg which is Icelandic for "Healing Hill" which will take his gardening hobby to a professional level.

When Alex is not busy with all of those hobbies, he may be seen collecting heirloom seeds, millefiori glass (Italian for "thousand flowers"), or pokemon cards. His favorite food is a cheeseburger, even a veggie burger, and he is currently working on a recipe for a veggie burger with mostly beans, seeds, and rice.

If you noticed Alex's photo, you might have guessed that his favorite football team is the Jaguars. He also enjoys The Flash comic and TV show. His favorite video game is Halo and card game is pokemon (Gotta Catch 'Em All!) 

Joyce Williams

If you have ever stepped foot into the Jacksonville Center for Clinical Research building on University Blvd. then you have probably met Joyce M. Williams. Joyce has been the Director of First Impressions here since March 2, 1998, and she became the first African American shareholder at JCCR in 2003.

Joyce is an ordained minister! She attended Jacksonville Theological Seminary and graduated in May 2007 with an Associates Degree in Religious Arts of Biblical Studies. She is very involved in her church; she is the Lead Vocalist, #1 Choir Director, Church Secretary, President of the Missionary Board, and Deaconess.

If all of this doesn't keep Joyce busy enough, she also collects thimbles - she has over one hundred! She also loves to color large coloring pads and books. Some of Joyce’s favorite foods are spaghetti, fried chicken and seafood. If you have met Joyce, you can agree that she has a great love for her job and all the people that she meets. 

Julie Baker

Julie Baker - Registered Nurse and a Clinical Research Coordinator at Jacksonville Center for Clinical Research (JCCR).

My husband was transferred to Jacksonville in 1993, at the same time our CEO Dr. Koren happened to be looking for a research nurse.  We moved from Pensacola, where I had worked for physicians for 10 years.  My favorite part of that job was coordinating clinical research.  So I was excited to have the chance to do research fulltime in Jacksonville.  Little did I know that I had found the best job in Jacksonville!  I was the first person hired fulltime for Dr. Koren’s research team.  It has been a privilege to be a part of the growth of JCCR, doing such important work with such great people! 

I’ve been married to my die hard Cubs fan for 40 years, and we still are each other’s favorite person to be with!  We both love exploring new places, especially our wonderful National Parks.   We are known for planning our travels a year or more in advance! 

After living near the Gulf Coast for 13 years, and in Jacksonville for 24 years, we are spoiled by our fabulous seafood.  We considered moving to the mountains when we retire, but would miss the seafood too much.  So we found our forever house in Jacksonville.  We decided Jacksonville is a great home base, and we can travel anywhere from here.

As a nurse, patient education and safety have always been important to me.  Since JCCR shares the same values, this career has been a terrific fit for me for 24 years. 

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