Our Mission & Vision
Internal Medical Center’s Clinical Research Division, which has been in place since April 2014, has been actively working with its internal network of clinicians to support patient care. Internal Medicine Center’s Division of Clinical Research serves to uphold IMC’s commitment to providing the Alabama Gulf Coast with the latest in healthcare advancements through robust clinical trials.
The mission of the Research Department at IMC is to support a rigorous program of research by our accomplished group of multi-specialty physicians, encouraging the highest standards of quality, and fostering ethical conduct in research. Department responsibilities include:
- Facilitating strong programs of interdisciplinary research
- Identifying the best researchers for your project needs
- Streamlining of our collaboration from non-disclosure agreement through the contracting process to study start-up
- Regulatory research compliance including appropriate standards for the protection of human subjects
- Qualified on-site research support staff to drive patient recruitment, retention, and excellent sponsor communication
- Sophisticated electronic data systems and support staff to provide access to specific the patient population from our large practice to meet your inclusion criteria; facilitating monitoring of research data.
An additional benefit of working with the largest independent multi-specialty clinic in Mobile, Alabama, is access to the many areas of world class research. Our core research areas include:
- Family Practice
- Internal Medicine
Specific Primary Investigators:
- Cody Barnett, MD, FACG
- Coby N. Harrison, MD
- Jason M. Harrison, MD
- Donald B. Sanders, MD
- Deepak Kumar, MD
- Jonathan Siegel, MD, FACG
- Judson K. Menefee, MD, FACE
- Michael K. Sanders, MD, FASGE
What is a clinical research study?
A clinical research study (or clinical trial) is a research study that uses human volunteers to answer specific health questions and find new treatments and ways to improve health. Clinical research studies help physicians and scientists develop improved treatments and even cures for many medical problems. The research, which is conducted on-site at Internal Medicine Center, relies on patients who volunteer to try a new treatment. If you’re interested in participating in a clinical research study, please click on the most recent study below, read the requirements and fill out the enclosed form.
Our team focuses on offering additional treatment options for our patients. Current enrolling studies include:
- AbbVie SONAR M11-352
The purpose of this study is to evaluate whether or not Atrasentan, an experimental drug used for the treatment of various types of cancer, is effective in delaying or worsening of kidney disease in patients with Type 2 Diabetes Mellitus and kidney disease.
More than 800 research centers and approximately 4,148 patients will participate in this study, which is expected to last for 4.5 years. Patients who participate in this study will receive Atrasentan or Placebo (a look-a-like tablet, which has no active drug) to be taken once daily, as well as lab tests, EKG, and physical examinations and oversight by an Internal Medicine Center by Dr. Judson Menefee.
- Eli Lilly VIVID B5K-MC-IBHD
This open-label study is designed to evaluate the safety and efficacy of Human Regular U-500 Insulin administered by an insulin pump compared to multiple daily injections in patients with Type 2 Diabetes. Study participation will include approximately 17 visits in a 30-week time frame. Appointments include diabetic education, lab tests, EKG, blood glucose monitoring and physical examinations and oversight by Dr. Judson Menefee.
- Boehringer-Ingelheim 1245.29
Hypertension is four times more common in African-Americans than Caucasians. This study will evaluate the glucose and blood pressure lowering effects of Empagliflozin, a drug approved for Type 2 Diabetes. African American patients who have Type 2 Diabetes will either be given Empagliflozin or a Placebo daily. The study will last approximately 24-weeks and involves 11 clinic visits including lab tests, blood pressure and glucose monitoring, ECG, and physical examinations as well as oversight by Dr. Donald B. Sanders.
- AbbVie P11-282 Registry
This research study collects long-term safety information on treatment of persons with moderate to severe active Ulcerative Colitis (UC). This study is a non-interventional (observation) registry, which aims to collect information on approved medications for ulcerative colitis under real-life conditions. This long-term study, lasting approximately ten years, will collect data on an annual basis from each participating patient during regularly scheduled office visits regarding UC. Dr. Johnathan Siegel oversees this study.
What are the potential benefits of participating in a clinical study?
While there is no guarantee that you will benefit from taking part in a clinical research study, there are numerous potential advantages, including possible health improvements from new treatments not available to the public, interaction with physicians and nurses who are at the leading edge of medical science, and close medical monitoring of your condition. Also, you may feel satisfaction from participating in studies that may contribute to new medical knowledge and that have the potential of helping others with similar illnesses. Most clinical research studies provide study-related procedures and treatments at no cost to the volunteer.
Types of clinical trials
Clinical research studies may test new treatments, new combinations of drugs, medical devices or new medical approaches. Some research studies look for better ways to screen, diagnose or prevent disease. Others may look at the influence of genetics or the outcomes of medical treatments, such as improved quality of life or cost effectiveness.
Clinical research studies of new drugs are conducted in three phases:
Phase One: Tests a new medicine’s safety in the human body. A small number of healthy volunteers are needed for this step.
Phase Two: Tests for effectiveness and dosage in several hundred patients. Often there are two groups: One receives the standard treatment or placebo (inactive pill), and the second receives the new treatment.
Phase Three: Measures the drug or procedure against the best standard treatment. This portion is the last phase before submission to the Food and Drug Administration (FDA) for approval. If approved, the drug will be available in pharmacies.
FDA believes that obtaining a research participant’s verbal or written informed consent is only part of the process. Informed consent involves providing a potential participant with:
- Adequate information to allow for an informed decision about participation in the clinical investigation.
- Facilitating the potential participant’s understanding of the information.
- An appropriate amount of time to ask questions and to discuss with family and friends the research protocol and whether you should participate.
- Obtaining the potential participant’s voluntary agreement to participate.
- Continuing to provide information as the clinical investigation progresses or as the subject or situation requires.
What risks are involved in clinical trials?
Side effects and risks exist with almost any treatment, whether it is a traditional, conventional treatment or a clinical research study. Some treatments that are being tested have side effects that can be unpleasant, serious or even life-threatening. However, many safeguards exist to ensure that clinical research studies as safe as possible and to protect patient rights. Before a new treatment is given to patients, it is carefully studied in the laboratory. Laboratory research establishes how best to use the new methods or treatments effectively in people while minimizing risks. However, because the treatment being studied is new, doctors don’t always know what side effects may occur. All known risks including non-physical risks such as inconvenience, emotional risk, financial risks or risk from confidentiality breach should be fully explained to you by the researchers.
Cost is an important consideration for a patient thinking about entering a clinical research study. Most studies provide the product, drug or treatment and any research-related procedures at no cost to the participant. Clinical research studies that test a treatment may require clinic or hospital visits, X-rays, blood tests or other medical procedures. Some studies may have a sponsor that pays some or all of the costs. Sponsors could be federal agencies or the company that makes the new drug or device.
Health insurance and managed care providers do not always cover all patient costs in clinical research studies. Before making any decisions, you should call your insurance company to learn what their coverage would be for a specific clinical study. Also, IMC patient account representatives are available to work with you and your insurance company on reimbursement issues for clinical research studies. In many cases, patients do not pay out-of-pocket for participating in a clinical research study.
For more information on Internal Medicine Center’s Clinical Research contact Robyn Simmons, RN at firstname.lastname@example.org or Vicki Wren, RN at email@example.com. You can also call 251.414.5900 or visit www.InternalMedicineCenter.org.