Services

Clinical Research Division

Our Mission and Vision

Alabama Medical Group’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. The Division of Clinical Research serves to uphold AMGs commitment to providing the Alabama Gulf Coast with the latest in healthcare advancements through robust clinical trials.

The mission of the Clinical Research Department 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, physician-owned, multi-specialty medical clinic in Mobile, Alabama, is access to the many areas of world class research. Our  areas of research include:

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

Specific Primary Investigators:

  • Cody Barnett, M.D., FACG
  • Edward G. Carlos, M.D.
  • Susan B. Fleet, M.D.
  • Panayoitis Grevenitis, M.D.
  • Jessica Kantrales, PA
  • Deepak Kumar, M.D.
  • Judson K. Menefee, M.D., FACE
  • Michael K. Sanders, M.D., FASGE
  • Alan R. Shain, M.D.
  • Jonathan Siegel, M.D., FACE

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, it will not affect your regular treatment from your physician and you may discontinue at any time.

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

  • Ulcerative Colitis Registry

This clinical trial 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 10 years, will collect data on an annual basis from each participating patient during regularly scheduled office visits regarding UC. This clinical trial is overseen by Johnathan Siegel, M.D.

  • Crohn’s Disease

This clinical trial research study is designed to compare the efficacy of a new type of 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 conventional treatments. 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 7 additional visits over approximately 52 weeks.  The study related visits will include physical examinations, endoscopies, 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. This clinical trial is overseen by Johnathan Siegel, M.D.

  • Diabetic Gastroparesis

This clinical trial research study is designed to evaluate the efficacy and safety of a new treatment for Diabetic Gastroparesis compared to placebo (inactive drug). Eligible patients will complete up to seven visits over approximately 16 weeks with 12 weeks receiving study treatment or placebo. For patients completing the all seven visits over 16 weeks may be eligible to continue for an additional eight visits over approximately 46 weeks, receiving study treatment or placebo. The study related visits will include physical examinations, blood pressure and glucose 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. This clinical trial is overseen by Johnathan Siegel, M.D.

  • Psoriatic Arthritis

This clinical trial research study is designed to compare the efficacy of a new type of biologic treatment, a JAK-1 inhibitor, against placebo (inactive drug) in the treatment of Psoriatic Arthritis. Eligible patients will complete up to 9 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. This clinical trial is overseen by Deepak Kumar, M.D.

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 1: 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 2: 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 3: 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 4: 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: