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Research & Clinical Trials

About the Borland-Groover Clinic Research Department

Our clinic has been active in both internal and external funded research programs for over 10 years 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 research development concerns worldwide. We are actively involved in pharmacologic outcome clinical trials especially with new agents in early Phase II and 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 internal ability to package and provide radiologic, endoscopic, and infusion services on site at our facility. We are involved in device studies, investigating new forms of endoscopes and ablation techniques.

We have also done studies in other areas of health care, including anesthesia, women’s health, allergy and immunology. Many of our research projects have been presented nationally and internationally such as the presentation of our experience with double-balloon enteroscopy to the American College of Gastroenterology, and our experience with Sphincter of Oddi Manometry which was presented 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.


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.

Current studies

CROHN’S DISEASE

A Safety and Efficacy Study of BLI-1300 Ointment in Symptomatic Perianal Crohn’s Disease
Condition: Perianal Crohn’s Disease
Interventions: Drug: BLI-1300 low dose; Drug: BLI-1300 high dose; Drug: placebo

A Study to Investigate the Efficacy and Safety of GSK1605786A in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease
Condition: Crohn’s Disease
Interventions: Drug: GSK1605786A; Drug: Placebo

A Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients With Moderately
to Severely Active Crohn’s Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy (UNITI-1)
Conditions: Crohn’s Disease; IBD; Colitis; Inflammatory Bowel Disease
Interventions: Drug: Group 2 ustekinumab 130 mg; Drug: Group 3: ustekinumab approximately 6 mg/kg; Drug: Group 1: Placebo

A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn’s Disease (UNITI-2)
Conditions: Crohn’s Disease; Inflammatory Bowel Disease; IBD; Colitis
Interventions: Drug: Group 3: ustekinumab approximately 6 mg/kg; Drug: Group 1: Placebo; Drug: Group 2 ustekinumab 130 mg

Efficacy and Safety of Trichuris Suis Ova (TSO) as Compared to Placebo
Conditions: Crohn’s Disease
Interventions: Biological: Trichuris suis ova (TSO);  Biological: Placebo

HEPATITIS C

A Study to Compare the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir,Peginterferon-Alfa-2a, Ribavirin) to Standard of Care in Subjects With Chronic Hepatitis C With Compensated Cirrhosis
Condition: Chronic Hepatitis C Virus
Interventions: Drug: VX-222; Drug: telaprevir; Drug: ribavirin; Biological: peginterferon-alfa-2a

TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy
Condition: Hepatitis C
Interventions: Drug: TMC435; Drug: TVR

IRRITABLE BOWEL SYNDROME

A Multi-Center Trial to Determine the Safety and Efficacy of LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
Interventions: Drug: 250 mg LX1033 tablets; Drug: Placebo tablet

ULCERATIVE COLITIS

Randomized Placebo Controlled Trial of Budesonide MMX® 9 mg in Patients With Ulcerative Colitis Currently on a 5-ASA
Condition: Ulcerative Colitis
Interventions: Drug: Budesonide; Drug: Placebo; Procedure: Procedure/Surgery: Blood sampling, endoscopy

All clinical trial information obtained directly from http://clinicaltrials.gov/. Updated 9/30/2012

Understanding clinical trials

What is a clinical trial?
Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. ClinicalTrials.gov includes both interventional and observational types of studies. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.

Why participate in a clinical trial?
Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.

Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called “inclusion criteria” and those that disallow someone from participating are called “exclusion criteria”. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

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 are the benefits and risks of participating in a clinical trial?

Benefits

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.

Risks

There are risks to clinical trials.

  • There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
  • The experimental treatment may not be effective for the participant.
  • The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

What are side effects and adverse reactions?
Side effects are any undesired actions or effects of the experimental drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.

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?

Research Staff

Medical Director:
Kyle Etzkorn, M.D., F.A.C.P., C.P.I.

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

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.


Study Coordinator: Sara Benner, R.N., C.C.R.C.

Bio: Sara has been working in clinical research since 1997. She joined Borland-Groover Clinic Research Department in 2005. Her research experience includes studies in Hepatitis, Crohn’s Disease, Ulcerative Colitis, Gastroesophageal Reflux, Erosive Esophagitis, Irritable Bowel Syndrome, Iron Deficiency Anemia, Coronary Artery Disease, Congestive Heart Failure, Tachycardia, Osteopenia, Pain Management, and Sedation. She currently works as a clinical research coordinator on Phase I - Phase IV trials. Sara is certified in BLS and ACLS, IATA trained, and CITI trained in GCP & ICH. Her professional affiliation includes the Association of Clinical Research Professionals.

Sara received her Associates of Science in Nursing from Brevard Community College.


Study Coordinator: Jackie Hazelip, R.N., B.S.N., C.C.R.C.

Bio: Jackie has been working in clinical research since 2006. She joined Borland-Groover Clinic Research Department in 2007. Her research experience includes studies in Hepatitis, Crohn’s Disease, Ulcerative Colitis, Gastroesophageal Reflux, Erosive Esophagitis, Irritable Bowel Syndrome, Iron Deficiency Anemia, COPD and Asthma. She currently works as a clinical research coordinator on Phase I - Phase IV trials. Jackie is certified in BLS, ACLS, and IATA trained, and CITI trained in GCP & ICH. Her professional affiliation includes the Association of Clinical Research Professionals.

Jackie received her Bachelor of Science in Nursing from Florida State College at Jacksonville.


Study Coordinator: Laurie Krause, R.N.

Bio: Laurie joined the clinical research team in 2011. She joined Borland-Groover Clinic in 2004, working in both the Borland-Groover Clinic Infusion Center and Jacksonville Center for Endoscopy. Her research experience included studies in Crohn’s Disease, Ulcerative Colitis, Pancreatic Pseudocysts,Diabetic Gastroparesis and Hepatitis. She currently works as a clinical research coordinator on Phase II - Phase IV trials. Laurie is certified in BLS, ACLS, and IATA trained, and CITI trained in GCP & ICH.

Laurie received her Bachelor of Arts in English from State University of New York at Geneseo. She received her Associates of Science in Nursing from Westchester Community College.


Study 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.


Administrative Assistant: Jennifer Chojn

Bio: Jennifer started at Borland-Groover Clinic in 2008 and joined the clinical research team in 2010.

Jennifer received her Bachelor of Arts in Education from University of North Florida.


Principal investigators: