Number 1 in enrollment in the ACTIVE Study from June 2005 to March 2006. Principal Investigator: J. 
NGHC Research
Our mission is to provide the patients of Northeast Georgia with the newest and most innovative therapies in the treatment of cardiovascular and peripheral diseases. We conduct research in compliance with the guidelines of Good Clinical Practice in the Code of Federal Regulations, and in compliance with the policy and procedures of the Institutional Review Board.
Title 21 – Food & Drugs
Good Clinical Practice Parts 11, 50, 54, 56,
312, 314
Title 45 – Public WelfarePart 46 Protection of Human Subjects
ICH Guidelines
Who sponsors the clinical trial?
The clinical trial is sponsored by the drug or device company that developed the investigational treatment.
Who conducts the clinical trial?
Research is conducted by a doctor and a research team. The research team may include other doctors, nurses, social workers, pharmacists, and others.
Who can be in a clinical trial?
Each clinical trial has certain requirements that patients must meet in order to participate. These requirements can include age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
What is expected for patients that volunteer?
For a patients that volunteers to participate in a clinical trial, in some studies the following may occur: a physical examination, review medical history, review medications, receive instructions for participating in the trial, and frequently monitor the patient’s health. Some clinical trials may require the patient return to the research facility for more tests or doctor visits than would occur if the patient was not participating in the trial.
Patients that volunteer to participate in a clinical trial may also receive, at no cost, clinical trial-related: medical care, investigational treatments, and test/procedures.
What is an informed consent?
The informed consent contains information about the study including the purpose, procedures to be performed, required follow-up visits, risk, benefits, contact information for the study doctor, cost, compensation if any, and confidentiality statement.
The informed consent will be reviewed with the potential patient volunteer by the research staff. If the patient agrees to volunteer for the trial, then the patients will sign and date the informed consent.
What are the benefits and risks of participating in a trial?
The National Institutes of Health highlight multiple benefits and risks associated with participating in a clinical trial. Visit www.clinicaltrials.gov
Possible benefits include:
¨ Play an active role in their health care
¨ Gain access to research treatments before they are widely available
¨ Obtain expert medical care at health care facilities during the trial
¨ Help others by contributing to medical research
Possible risks include:
¨ 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 time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays, or complex dosage requirements.
Who makes sure volunteer’s rights are protected?
Clinical trials are reviewed and overseen by an ethics committee. The ethics committee is referred to as an IRB (Institutional Review Board). The IRB is a group of doctors, nurses, and people from the community. The role of the IRB is to review all clinical trials to help protect the patient volunteer’s rights and safety.
In addition, the FDA (Food and Drug Administration), a department of the US government, sets requirements for drug testing. The FDA will also review the results from clinical trials to decide if an investigation drug or device should be made available to the general public.
What happens after the clinical trial?
After a clinical trial is completed the data is evaluated to determine if the investigational treatment was safe and effective. If the results showed the investigational treatment was safe and effective, then the sponsor may move to the next phase of the clinical trial. There are 3 clinical trial phases that a drug must go through before the FDA will review the data for approval to make it available to the general public.
What are the Phases of Clinical Research?
Phase 1: Researchers test an investigational drug for the first time in humans by giving it to a small number of healthy people to evaluate its safety, determine a safe dosage range, and identify any side effects.
Phase 2: The investigational drug is given to a large number of people who have a particular disease or condition, to determine its effectiveness and to further evaluate its safety.
Phase 3: Several hundred to several thousand people with the appropriate disease or condition participate in these studies. The investigational drug undergoes additional testing to further determine it safety and effectiveness, monitor side effects, and compare it ot commonly used treatments.
Phase 4: After a drug is available by prescription, additional information is gathered to assess the drug’s risk, benefits, and use.
What types of trials are available at Northeast Georgia Heart Center (NGHC)?
NGHC participates in a variety of clinical trials. The types of clinical trials include:
¨ Atrial Fibrillation
¨ Heart Failure
¨ Heart Attack
¨ ICD
¨ Pacemaker
¨ Carotid
¨ Peripheral
What are the type of questions to ask?
· What is the purpose of this clinical trial?
· How long will I be in the clinical trial?
· How often will I need to go to the clinic/hospital?
· What tests and procedures are involved?
· Will my medical records remain confidential?
· Is there a chance I will receive placebo?
· What are the benefits and risks associated with the clinical trial?
· How do the benefits and risks compare with those of my current treatment?
· Is follow-up care part of this clinical trial?
· How will my condition be monitored?
· What safeguards will be in place for my protection?
· Will results of the clinical trial be provided to me?
· Will there be any additional costs to me?
What is a clinical trial?
A clinical trial is a research study in which researchers evaluate the safety and effectiveness of investigational treatments. The investigational treatment is given to patients that volunteer to participate in the clinical trial.
Once investigational treatments are found to be safe and effective then become available for doctors to use to treat patients.
Clinical trials are conducted around the world in an effort to develop the highest level of treatment available to treat many of the today’s health problems.
Why should I volunteer?
Researchers need patients to volunteer for clinical trials in an effort to discover new or improved treatments for many of the health problems that patients may have.
If it were not for patients volunteering to participate in clinical trials, the treatment that you currently receiving for your health problem would not be available. All treatments available today underwent a clinical trial to provide information to the FDA regarding its safety and effectiveness.
Research Staff
J. Jeffrey Marshall, M.D., F.A.C.C., S.C.A.I.
Director of ResearchA leader in the field of clinical research. Dr. Marshall has over 20 years of experience in conducting clinical trials. He has held appointments at Crawford Long Hospital of Emory University, Atlanta VA Medical Center, and Virginia Commonwealth University.
Gina Nesbit, R.N., C.C.R.C.
Research ManagerMs. Nesbit has 9 years of experience in conducting clinical trials. Her prior experience includes conducting clinical trials at Crawford Long Hospital of Emory University, as well as, nursing in CCU, CVICU and MICU at Crawford Long Hospital of Emory University.
Email:gnesbit@ngheartcenter.com
Donna Patrick, R.N., C.C.R.C.
Research NurseMs. Patrick has over 5 year of experience in conducting clinical trials. Her prior experience includes supervisor in the ER at Northeast Georgia Medical Center and legal nurse consultant.
Email:dpatrick@ngheartcenter.com