CLINICAL RESEARCH TRIALS
Medical Research is crucial to understanding diseases and developing new ways to prevent, detect, and/or treat health problems. Most of our clinical trials focus on new ways of treating DIABETES and the complications of diabetes.
What is a Clinical Trial?
Clinical trial. Clinical study. Research study. They all mean about the same thing - a closely monitored scientific study of how a new or investigational medication or treatment works in people. They determine how effective a medication or treatment is in combating a disease or medical condition.
The discovery of new treatments is impossible without the support of patients participating in clinical studies. We carefully match individual patient's needs with each study's criteria to determine eligibility. Participants in the studies have access to cutting-edge care that is not available in many other doctor’s offices or medical centers.
Why Are Clinical Trials Important?
Medical treatments have come a long way in the last 30 years. Today, many more patients are living healthier lives with medical conditions or disease; and many more are surviving serious illnesses who might not have survived years ago. This is due to improvements in medications, therapies, and diagnostic tests. These improvements have come about through research. However, there still are many questions to be answered about treatments, and room for improvement of current medications. These are the reasons why research is important and a part AM Diabetes.
Why would you be Interested in Clinical Trials?
Usually patients participate in clinical trials because they hope to benefit themselves, and because they want to contribute to a research effort that helps others. A patient's well-being is paramount in a clinical trial. If you are involved in a clinical trial, you will be closely monitored to see how you are responding to treatment and to determine your overall well-being. Whether to participate in a study, or whether to continue to participate in a study is always up to you… you may withdraw from a study at any time.
Are Clinical Trials Safe?
Patient safety is extremely important to us at AM Diabetes. Before a clinical trial begins, the treatment must show that it has potential benefit. It also must meet rigorous government standards (i.e. FDA) and scientific requirements for safety, and have acceptable side effects. Physicians, and research nurses follow strict rules when conducting clinical trials. These rules protect the interests of the patient and remove any bias from the study. In addition, no patients may be enrolled in a clinical trial until the trial has been approved by an Institutional Review Board (IRB). The board is responsible for evaluating proposed trials for ethical research practices, patient safety and patients' rights.
How can I know Exactly what is Involved in a Clinical Trial?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help you decide whether or not to participate, you will be given an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are also explained in this document. After reading it, you will be encouraged to ask questions so that you have a thorough understanding. You then decide whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
How much does it Cost to be in a Clinical Trial?
All procedures/exams directly related to study participation (such as office visits, lab work, physical exams, diagnostic procedures, doctor time and nurse time) are offered free of charge. In addition, the study medication in a clinical trial is provided free of charge, and usually there is compensation for time and travel.
How can you Participate in a Clinical Research Trial?
You may choose to participate in a clinical research trial, but the study doctor must determine whether you are eligible. You must meet certain study criteria to participate. Each study includes patients who have the same or very similar health profiles based on specific criteria related to: medical history, medication history, and current medical status.
You do not have to be a patient to participate in one of our studies. You would see us for your study visits, and continue to see your own doctor for your routine care. We will gladly inform your current doctor of your participation in the study. At your request, we will also send your study lab and test results to him to include in your medical record.
If you are interested in participation or learning more about our current studies,
please call AM Diabetes (901.384.0065) and ask to speak to the study nurse.