Research & Clinical Trials
Nutritional Intervention for Crohn’s Disease with The Research Center
All clinical trial information obtained directly from http://clinicaltrials.gov/. Updated 4/26/2015
Volunteers are needed for Borland-Groover Clinic Research
Clinical trials involve people like you. Your participation is not only important to clinical research, it also provides clinical data needed for medical advances to become available to the public. Clinical trials look at new ways to prevent, detect, or treat diseases or conditions. Clinical research also provides valuable information about health and disease progress.
At Borland-Groover Clinic we value our patients and strive to meet your care expectations through a delivery system based on compassionate, confidential care. Our commitment to providing excellent healthcare also involves conducting clinical research with the purpose of helping our patient’s live longer, healthier lives.
Our clinic has been active in both internal and external funded research programs since 1995 and our mission is to provide a basis of understanding and treating medical illnesses. Several of our principal investigators came to the clinic after having vibrant academic careers, in basic and clinical research. Many of our investigators have been lead authors in cutting edge manuscripts in scientific journals.
We have a long history with many leading pharmacology, private research and development centers worldwide. We are actively involved in pharmacologic outcome clinical trials especially with new agents in Phase I through Phase III. Currently, we are able to offer patients access to new drugs in clinical trials years before they become commercially available.
Our research group is strengthened by the clinic’s ability to provide radiologic, endoscopic, and infusion services on site at our facility. We have experience in other areas of health care, including anesthesia, women’s health, allergy, device, radiology, nutrition, and immunology. Many of our research projects have been presented nationally and internationally such as the American College of Gastroenterology, and at Digestive Disease Week.
Be sure to read the publications written by our physicians on advancements and new findings in the area of gastrointestinal research.
Because of the willingness of thousands of volunteers like you, medical advances have been made through clinical research and millions of people have seen improvement in their health. As clinical research opens new doors to finding ways to diagnose, prevent, treat, or cure diseases and disabilities; the participation of volunteers is essential to help us continue to find those answers.
Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.
For more information about our research & clinical trials or if you have any questions contact us.
Learn more about becoming a volunteer - volunteer information.
Understanding clinical trials
What is a clinical trial?
Clinical trials involve people like you. Your participation is not only important to clinical research, it also provides the clinical data needed for medical advances to become available to the public. Clinical trials look at new ways to prevent, detect, or treat disease or conditions. Clinical research also provides valuable information about how health and disease progress.
At Borland-Groover Clinic we value our patients and strive to meet your care expectations through a delivery system based on compassionate, confidential care. Our commitment to providing excellent healthcare also involves conducting clinical research with the purpose of helping our patients live longer, healthier lives.
Why participate in a clinical trial?
People participate in clinical studies for a variety of reasons including: receiving the newest treatment, additional care and attention from the clinical trial staff, helping others, personal interest in research, and playing an active role in their own health care. Research participants may be compensated for meals, travel costs, time and effort that they devote to a clinical trial.
Who can participate in a clinical trial?
Clinical studies have guidelines about who can participate. Factors that allow someone to take part in a clinical study are called “inclusion criteria.” Factors that do not allow participation are called “exclusion criteria.” These criteria are based on considerations such as: age, sex, disease, and other medical conditions. The criteria are used to find appropriate people for the study, ensure their safety, and to help researchers find needed information.
What happens during a clinical trial?
The clinical trial process depends on the kind of trial being conducted (See What are the different types of clinical trials?) The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.
Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
What is informed consent?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant’s native language is not English, translation assistance can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
What are the benefits and risks of participating in a clinical trial?
Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:
- Play an active role in their own health care.
- Gain access to new research treatments before they are widely available.
- Obtain expert medical care at leading health care facilities during the trial.
- Help others by contributing to medical research.
All medical research involves some level of risk.
- Risks and benefits may be different depending on the study.
- The research team is required to tell you about known risks, benefits and available alternative health care options.
How is the safety of the participant protected?
The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants’ names will remain secret and will not be mentioned in these reports (See Confidentiality Regarding Trial Participants).
What should people consider before participating in a trial?
People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.
- What is the purpose of the study?
- Who is going to be in the study?
- Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
- What kinds of tests and experimental treatments are involved?
- How do the possible risks, side effects, and benefits in the study compare with my current treatment?
- How might this trial affect my daily life?
- How long will the trial last?
- Will hospitalization be required?
- Who will pay for the experimental treatment?
- Will I be reimbursed for other expenses?
- What type of long-term follow up care is part of this study?
- How will I know that the experimental treatment is working? Will results of the trials be provided to me?
- Who will be in charge of my care?
What kind of preparation should a potential participant make for the meeting with the research coordinator or doctor?
- Plan ahead and write down possible questions to ask.
- Ask a friend or relative to come along for support and to hear the responses to the questions.
- Bring a tape recorder to record the discussion to replay later.
Bio: Dr. Etzkorn has been involved in clinical research since 1994. He joined Borland-Groover Clinic in 1996. His wide-array of research experience includes studies in Hepatitis, Crohn’s Disease, Ulcerative Colitis, Gastroesophageal Reflux, Erosive Esophagitis, Irritable Bowel Syndrome, Iron Deficiency Anemia, Sedation, Diverticulitis, and Duodenal Ulcers. He currently provides medical oversight to the clinical research department and is one of our primary Principal Investigators. He is certified in BLS, ACLS, and CITI trained in GCP & ICH. His professional affiliations include the Association of Clinical Research Professional as a Certified Physician Investigator.
Dr. Etzkorn attended medical school at the University of Missouri. He completed his Fellowship in Gastroenterology at University of Texas Health Science Center and his Fellowship in Therapeutic Endoscopy at University of Illinois Hospital.
Director of Research: Laura Walter, MPH, CCRP
Sponsors and CRO’s contact Laura at 904-265-4836. If you are a patient or interested in participating in a study contact Research at 904-680-0871.
Bio: Laura has been working in clinical research since 2001. She joined Borland-Groover Clinic Research Department in 2005. Her research experience includes studies in Hepatitis, Crohn’s Disease, Ulcerative Colitis, Irritable Bowel Syndrome, Breast Cancer, Melanoma, Small Cell and Non-Small Cell Lung Cancer. She currently works with sponsors to bring new clinical trials to our research department. She also manages study start-up, regulatory documentation, budgeting and contracting for Borland-Groover Clinic Research Department, while providing staff oversight to the clinical research coordinators. She is certified in BLS, IATA trained, and CITI trained in GCP & ICH. Her professional affiliation includes the Society of Clinical Research Professionals.
Laura received her Masters of Public Health from New York Medical College.
Regulatory Specialist/Coordinator: Nancy Chaffin, C.C.R.C.
Bio: Nancy has been working in clinical research since 2004. Nancy joined the clinical research team of Borland Groover Clinic in 2011. Her research experience included studies in Crohn’s Disease, Ulcerative Colitis, Pancreatitis, Clostridium difficile, and Hepatitis and HIV. She currently works as a clinical research coordinator on Phase II - Phase IV trials. Nancy is certified in BLS, IATA trained, and CITI trained in GCP & ICH. Her professional affiliation includes the Association of Clinical Research Professionals.
Nancy received her Associate of Arts in Dietetics from Long Beach City College.
Study Coordinator: Marc Lojacono, C.C.R.P.
Bio: Marc has been working in clinical research since 1999. Marc joined the Borland Groover clinic in -2014. His research experience includes studies in Hepatitis C, Crohn’s Disease, Ulcerative Colitis, Stroke, Parkinson’s, Epilepsy, Multiple Sclerosis, Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), Restless leg syndrome, Bipolar, Breast Cancer, Hidradenitis Suppurativa, and Psoriasis. He currently works as a clinical research coordinator on Phase II - Phase IV trials. Marc is certified in BLS, IATA trained, and CITI trained in GCP & ICH. His professional affiliation includes the Society of Clinical Research Associates’ Certification.
Marc attended Florida Community College of Jacksonville.
Study Coordinator: Courtney Tadewald, C.N.A, C.C.R.P
Bio: Courtney has been working in clinical research since 2011 and is a Certified Nursing Assistant. Her research experience includes regulatory specialist , study start-up and recruitment coordinator. She also has experience with device and cardiology trials. She is currently working on Phase II and Phase III studies. Courtney is certified in BLS, IATA, phlebotomy, and GCP and ICH trained. Her professional affiliations includes the Society of Clinical Research Professionals.
Research Assistant: Rosemarie Stoner, B.S.
Bio: Rosemarie was Corpsman with the Navy and has extensive medical laboratory experience. Rosemarie is proficient in phlebotomy, PK/PG blood draws and long term blood draw studies. She is certified in Medical Laboratory, Medical Assisting, IATA, GCP and ICH.
Rosemarie received her Bachelor of Science in Clinical Research Administration from George Washington University and her Associate of Science in Medical Laboratory Services from Bronx Community College.
Research Assistant: Tiffany Clark, MPH, CPH
Bio: Tiffany has been working with Borland-Groover Clinic since 2016. Her research experience includes an International Field Intern for the University of San Francisco in Quito and a graduate research assistant for the University of South Florida.
Tiffany received her Masters of Public Health in Epidemiology and Global Communicable Diseases and her Bachelors of Science in Health Science from the University of South Florida.
Research Assistant: Anton Thomas
Bio: Anton has been working with Borland-Groover since 2016. His experience includes assisting at the University of North Florida (UNF) Economics and geography Department and as a AVID math and science tutor.
Anton received his Associates in Arts from UNF and is eligible for his Bachelors in Psychology in December of 2016 from the University of North Florida.