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Clinical Research Division

Our Mission and Vision

Alabama Medical Group’s Clinical Research Division has been in place since April 2014 and has been actively working with its internal network of clinicians to support patient care. Alabama Medical Groups’s Division of Clinical Research serves to uphold AMG’s commitment to providing the Alabama Gulf Coast and surrounding areas with the latest in healthcare advancements through robust clinical trials.

The mission of the Research Department at Alabama Medical Group 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 research areas include:

  • Diabetes
  • Family Practice
  • Gastroenterology
  • Geriatrics
  • Hypertension
  • Internal Medicine
  • Lipidemia
  • Rheumatology
  • Neurology
  • Infectious Disease

Providers participating in the conduct of clinical research at AMG:

  • Cody Barnett, M.D., FACG
  • Adrien Bodet, III, M.D.
  • Edward Carlos, M.D.
  • Susan Fleet, M.D.
  • Panayoitis Grevenitis, M.D.
  • Jessica Kantrales, PA-C
  • Deepak Kumar, M.D.
  • Judson K. Menefee, M.D., FACE
  • Patrick Nolan, M.D.
  • Michael K. Sanders, M.D., FASGE
  • Alan Shain, M.D.
  • Jonathan Siegel, M.D., FACG

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 Alabama Medical Group, 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. Participation in a clinical trial is voluntary, will not affect your regular treatment from your doctor, and you may discontinue at any time. For trials within Alabama Medical Group, patients do not pay for study visits as the visits are covered by study sponsor company. Patients may also be reimbursed for time and travel to the clinic for study visits.

Our team focuses on offering additional treatment options for our patients. Current enrolling studies include:

Psoriatic Arthritis

This study is to evaluate a new type of biologic treatment, a JAK-1 inhibitor, against placebo (inactive drug) in the treatment of Psoriatic Arthritis. This study treatment is a pill taken once a day. Eligible patients will complete up to nine visits over approximately 154 weeks. Patients may receive study treatment or placebo for the first 24 weeks of participation and all patients will receive study treatment from week 24 through week 152. The study related visits will include physical examinations, lab tests, X-rays, ECGs, blood pressure monitoring and joint assessments. Study participants will receive all study related care and treatment at no cost to them and are reimbursed for time and travel to study visits. This trial is overseen by Dr. Kumar.

Diabetic Gastroparesis

This study is to evaluate a new treatment for Diabetic Gastroparesis compared to placebo (inactive drug). The study treatment is a self-injection from a pen (similar to an insulin pen) that is taken two times a day. Eligible patients will complete up to seven visits over approximately 16 weeks with 12 weeks receiving study treatment or placebo. Patients completing the all seven visits over 16 weeks may be eligible to continue for up to an additional 46 weeks, receiving study treatment or placebo. The study related visits will include physical examinations, blood pressure and blood sugar monitoring, lab tests, ECGs, gastric emptying breath test and ongoing assessments of diabetic gastroparesis symptoms. Study participants will receive all study related care and treatment at no cost to them and are reimbursed for time and travel to study visits. This trial is overseen by Dr. Siegel.

Crohn’s Disease – 2 Trials

This study is to evaluate a new type biologic treatment, JAK-1 inhibitor, against placebo (inactive drug) in the treatment of Crohn’s Disease for patients that have previously failed biologic treatment or other, non-biologic treatments. The study treatment is a pill taken once a day. Eligible patients will complete up to 10 visits over approximately 26 weeks. Some eligible patients may be eligible to continue in the study up to seven additional visits over approximately 52 weeks.  The study related visits will include physical examinations, colonoscopies, lab tests, ECGs, chest X-ray, blood pressure monitoring, and ongoing assessments of Crohn’s Disease symptoms. Study participants will receive all study related care and treatment at no cost to them and are reimbursed for time and travel to study visits. This trial is overseen by Dr. Siegel.

This study is to compare the safety and efficacy of Humira® and Stelara® in treatment of Crohn’s Disease for patients that have never received a biologic treatment and have previously failed other, non-biologic treatments. This study treatment is given as an infusion for the first dose and self-injection with syringe for all follow up doses. Patients can return to the clinic for follow up injections if they are unable to given themselves or have someone to do it for them. Eligible patients will complete up to 12 study visits over approximately 76 weeks. Study visits will include physical examinations, colonoscopies, lab tests, ECGs, chest X-rays, blood pressure monitoring and ongoing assessments of Crohn’s Disease symptoms. Study participants will receive all study related care and treatment at no cost to them and are reimbursed for time and travel to study visits. This trial is overseen by Dr. Siegel.

HIV

This study is to compare FDA approved Bictarvy® to patients’ current HIV antiretroviral treatment. Eligible patients will be placed into one of two groups. One group of patients will switch from their current treatment to Bictarvy® at the beginning of the study and remain on Bictarvy® for up to 48 weeks. The 2nd group of patients will stay on their current HIV treatment for up to 24 weeks and switch to Bictarvy® at that time and remain on Bictarvy® for up to 24 weeks. Study visits will include physical examinations, lab tests, ECGs, and blood pressure monitoring. Study participates will receive all study related care and medication at no cost to them and are reimbursed for time and travel to study visits. This trial is overseen by Dr. Nolan.

GERD – Gastroesophageal Reflux Disease

This study is to compare a new type of treatment, a bile acid sequestrant, to placebo (inactive drug) for patients with gastroesophageal reflux disease. The study treatment is tablet, taken 3 at a time, taken two times a day along with the patient’s current GERD medication. Eligible patients will complete up to five visits for up to 15 weeks, receiving study treatment for up to eight weeks. Study visits will include EGDs, physical examinations, ECGs, blood pressure monitoring, and ongoing assessments of GERD symptoms. Study participants will receive all study related care and treatment at no cost to them and are reimbursed for time and travel to study visits. This trial is overseen by Dr. Siegel.

Type 2 Diabetes – Study will begin January 2019

This study is to compare three different doses of a new diabetes medication to insulin glargine. The study treatment is a self-injection given once each week. All eligible patients will be placed into one of four groups. Three of those four groups will each receive one of the three doses of the new study treatment. One of those four groups will receive insulin glargine. Eligible patients will complete up to 28 study visits for up to 111 weeks. Study visits will include diabetes monitoring, physical examinations, ECGs, blood pressure monitoring, and ongoing assessments of diabetes symptoms. Study participants will receive all study related care and treatment at no cost to them and are reimbursed for time and travel to study visits. This trial is overseen by Dr. Menefee.

 Ulcerative Colitis Registry

This study is not a treatment trial, but is to gather information about ulcerative colitis. This research study collects long-term safety information on treatment of patients 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. This trial is overseen by Dr. Siegel.

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 four phases:

Phase One: Tests a new treatment or device’s safety in the human body. Less than 100 to a few hundred healthy participants will be examined in this phase of a clinical trial.

Phase Two: Efficacy, safety and dosage are examined in participants having the condition to be treated by a new treatment or device. Often there are two groups in which participants are placed: One receives the standard treatment or placebo (inactive treatment), and the second receives the new treatment. In this phase, a few hundred participants around the country or world will examined.

Phase Three:  Efficacy, safety, and dosage are examined in volunteers having the condition to be treated by a new treatment or device as well. In this phase, more is known about the efficacy and safety of the new treatment or device than phase 2, but additional information is needed before it is submitted to the Food and Drug Administration (FDA. During or at the end of this phase of a clinical trial, the new treatment or device is submitted to the FDA for approval. If approved, the drug will be available in pharmacies. Several hundred to a few thousand participants around the country or world will be examined.

Phase Four: These are also called Post-Marketing Studies. The treatment or device has now been approved by the FDA. A phase 4 trial is conducted to further examine the treatment or device’s long-term efficacy. Thousands of participants around the country and work will be examined.

Informed Consent

FDA requires research participant’s written informed consent prior to the start of study participation. 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 an approved treatment or a clinical research study treatment. 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 patient receives a new study treatment, their medical history is thoroughly examined by the doctor.

Cost is an important consideration for a patient thinking about entering a clinical research study. Most studies provide the study drug or treatment and any research-related procedures at no cost to the participant. Clinical research studies 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. A study participant is not required to have medical insurance coverage as no study related procedures or visits are filed to health insurance.

For more information on Alabama Medical Group’s Clinical Research Division, contact: