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Research
 Click on a condition to see current research studies. Contact Information
For more information, please contact:  Cardiovascular disease remains the most common cause of death and disability for men and women in the United States, causing more than 900,000 deaths and greater numbers of disabling conditions each year. In fact, cardiovascular disease affects nearly one in four Americans and in the Southeast United States, the ratio is narrower. To date, research in cardiovascular diseases has expanded our understanding of the anatomy and physiology of the cardiovascular system as well as telling us more about drug therapy for the prevention and treatment of disease processes.  CVA is one of the largest cardiology group practices in the Southeast providing service to the Birmingham metropolitan area, and up to 22 surrounding counties in Alabama. Our Office of Clinical Research manages and coordinates inpatient and outpatient clinical trials in two Birmingham area hospitals and in three of our local outpatient clinics. Through our clinical trial activities, CVA plans to actively be a part of the process of bringing the most up-to-date care to our patients. Why do we conduct clinical studies here at CVA? Doing studies helps patients. We have observed that our patients generally do better when they are participating in studies. Conducting clinical trials gives CVA access to new technology (drugs and devices) and helps to keep our practice engaged in newer trends in cardiology. Overall, doing studies better serves our patients, our practice, our referring physicians and our research sponsors. 
 The research process is a slow and careful one. Research begins in the laboratory where theories and hypotheses are tested. Once proven to work in the lab, research moves to the preclinical phase. Preclinical ResearchPreclinical research is an essential step in the process of understanding the complexity and mechanisms of disease. This type of research allows scientists and clinicians to create models of disease states to uncover the behavioral and cellular processes responsible for the development of disease. As the precursors and course of action of a disease are more fully understood, preclinical research is then used to test and determine the safety and efficacy of treatment theories. The next step in research is the clinical phase. Clinical ResearchPhase 1Phase I clinical research is the first step in testing a new treatment in humans. These studies are usually small (10-15 participants) and designed simply to show that a treatment is safe in humans. In drug studies, the dose of the drug is incrementally increased to find the best dose. Phase IIPhase II clinical research studies are further tests of safety in a larger population. In addition, researchers are beginning to evaluate the effectiveness of the treatment. There are usually further refinements of the dose of a drug. Phase II studies are not designed to prove that a treatment works. Phase IIIPhase III clinical research studies are large studies designed to prove the effectiveness of a treatment and further confirm their safety. They are usually placebo-controlled, meaning that the new treatment will be compared to current standard therapy plus placebo. What is a placebo? A placebo is an inactive, harmless substance that is compared to active study drug. One group of patients receives the study (investigational) drug, while a second "control" group will receive a standard treatment along with placebo. Often the participant, the physician, and the study coordinator are "blind" to which group is getting the actual drug and which is receiving the placebo. The "blind" study method prevents bias on the part of the patient, the doctor and the study coordinator. Submission to the FDAOnce a Phase III study is complete, the data are analyzed and submitted to the FDA for approval of the drug or therapy. Phase IVPhase IV clinical research studies evaluate FDA-approved drugs for new indications. For example, a drug has been approved for high blood pressure. Investigators notice that patients on the medication for high blood pressure and who also have congestive heart failure show an improvement in their heart failure. Investigators then may do a Phase IV study of the drug in heart failure patients to see if their hypothesis is correct. If correct, the drug would then also be approved for congestive heart failure.  Why participate in a clinical study?Many people volunteer for a clinical study because the current treatment available for their condition is not effective or is partially effective, and participation in a clinical study might offer them a new alternative to standard therapy before it is available to the general public. Another reason people volunteer is to contribute to research efforts that may help patients in the future. What are the risks of participating in a clinical study?There may be risks associated with any clinical study. The principal investigator or study coordinator must explain all risks and potential risks, along with the potential benefits to the patient before they consent to become a participant in a clinical study. Also, since the drug or therapy is investigative (experimental), there are no guarantees that the drug or device being studied will be effective. Only the patient can decide whether or not it is appropriate to participate. What are the rights of a research volunteer?Research Subject's Bill of RightsPeople who volunteer to participate in an experiment (also called a research study or clinical trial) need to understand what is expected of them and why the research is being done. As you think about whether or not to volunteer, it is important that you know that you have rights in place to help protect you. These rights, listed below, will be further explained as you undergo the informed consent process. If you are asked to participate in a research study, you have the right to:
What does "informed consent" mean?The informed consent process is required for participation in all clinical studies involving human subjects. Individuals are given information about what is involved in the study, including procedures, possible benefits and risks. The physician or study coordinator encourages questions. After this information is presented, individuals can make a decision whether or not to participate. The individual's consent to participate is documented in their medical record. The following are some questions to consider before giving consent to become a research volunteer:
The answers to these questions should be in the consent document and can be explained more fully by the investigator or study coordinator. What does it cost to participate in a clinical study?Each study is different in what will and will not be paid for during the course of the clinical study. For example, some studies pay for all medications, doctor visits, tests, and treatments. Other studies will only provide the study drug at no cost to the patient and will submit the cost of other procedures and tests to the patient or their insurance company. Patients should freely discuss with their physician what costs are involved in their cases prior to participating in the study. This should also be outlined in the informed consent document. The general guideline is that those tests or procedures, done solely for the purpose of research, unless clinically indicated, are paid for by the study. Some studies provide a stipend for incidental costs incurred during the course of the study. How are research studies paid for?Research funding may come from the federal government (via the National Institute of Health), voluntary health agencies such as the American Heart Association, academic settings such as Duke or Cleveland Clinic, or private industry (pharmaceutical and/or biotechnology companies).  We have extensive experience conducting clinical research trials (Phase I-IV) in a variety of therapeutic areas:
Sponsors/Contract Research OrganizationsGovernment
Academic
Industry
 Clinical Research Steering Committee
Investigators
Coordinators
Support Staff
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