Address:
4365 Johns Creek Parkway
Suite 400
Suwanee, GA 30024
Ph: 678-205-3456
Fx: 678-205-3457

Clinical Research Coordinator:	Tabby Sapp; tabbysapp@gmail.com
Principle Investigator:	Lee E. Herman, MD
Regulatory Document Specialist:	Gigi Stoneback
Clinical Research Sub-Coordinator:	Elizabeth Kirkpatrick

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.

What happens during a clinical trial?

The clinical trial process depends on the kind of trial being conducted. 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?

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.

Current Studies:

High Cholesterol

M10-158
If you have high cholesterol or are taking a cholesterol medication, you may be interested in a 29 month cholesterol study called the “FIRST Study”. This study is looking at adding an investigational medication to traditional cholesterol medication to determine if it can reduce your risk for heart disease. You may qualify for this research study if you meet the following requirements:

• Age 45 and older
• Taking a cholesterol medication or have high cholesterol

As a qualified participant in this study, you may receive the following at no cost:

• Health exam including a full cholesterol workup, blood pressure, pulse, ECG, temperature, and weight measurement
• Medical history review
• Carotid artery ultrasound
• Dietary counseling and training from the American Heart Association guidelines
• Study medication as well as standard cholesterol therapy
• Appointed study coordinator to answer any study-related questions you have during participation

Type 2 Diabetes

Roche BC21625
Sometimes people with type 2 diabetes still have uncontrolled blood sugar levels even with the help of a healthy diet and exercise, with or without medication. If this sounds like you, then you may be eligible to participate in EMERGE-an international clinical research study exploring and investigational medication for type 2 diabetes. To participate in the study, you should:

• Be at least 18 years of age
• Have a diagnosis of type 2 diabetes
• Have uncontrolled blood sugar levels even with the help of a healthy diet and exercise, with or without medication
• Have not taken insulin for longer than 1 week during the past 6 months

If you are eligible for the study, you will receive study-related care and medication at no cost to you.

High Blood Pressure

Takeda Study
If you have high blood pressure, you may be eligible to participate in a voluntary clinical research study of an investigational medication for high blood pressure.  Qualified participants will receive, at no cost, the following study-related procedures:

• Blood pressure monitoring
• Laboratory tests
• Physical exams
• Electrocardiograms (ECGs)
• Office visits
• Study medication
• Compensation for time and travel may be available.

Arthritis

Precision
Bothered by arthritis? Concerned about heart disease? We are conducting a research study of 3 approved medications commonly used to treat pain due to osteoarthritis (OA) or rheumatoid arthritis (RA) in people who have or are at high risk for heart disease. Qualified participants will receive study-related medical care, regular study check-ups, and study medication at no charge. To qualify you must:

• Be 18 years of age or older
• Have had osteoarthritis or rheumatoid arthritis for at least 6 months
• Have been prescribed regular medication for your pain for at least 6 months
• Have or be at high risk for heart disease, which includes a history of heart attack, stroke or diabetes

Weight loss

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