Why be in a study?
There are several reasons why you might want to participate in a study. You may decide simply because it sounds interesting and you would like to help in the advancement of science. Or you may have symptoms of the disease or illness and want to help find better treatment options. You may also lack insurance and need treatment for the illness considered in a specific study.
TOP
How are studies approved and supervised?
Typically, the U.S. Food and Drug Administration (FDA) must authorize a company to conduct a study. This is considered and approved only after the company has previously performed years of laboratory testing and research. A second panel, the Institutional Review Board (IRB) must review and approve the study as well. IRBs are independent groups of healthcare professionals and other informed individuals who make sure study participants are not exposed to unnecessary risks and that each participant’s rights are fully protected. During a study there are several visits to our office by representatives of the company sponsoring the study to insure that we are strictly following the study plan. Also, at any point in time, auditors from the FDA may arrive to review the details of a specific study.
TOP
Who is considered for a study?
Anyone may participate in a study whether you are a patient in our practice or not. There are usually strict criteria to follow in order for a patient to volunteer in a study. The requirements for participation often include age, sex, diagnosis, severity of the medical condition and past history.
TOP
How do I know what I’m getting into?
There is a process called “informed consent” where a detailed written outline of the study and its requirements are made available to all volunteers. The outline explains how the study will be performed, how medications will be taken, what benefits a participant may receive, and what risks may be involved. As part of this process we explain discomforts and side effects from the medication which may be expected. During this time volunteers are encouraged to ask us, the clinical investigator, questions regarding the study. This process must be documented by the volunteer and our investigator before any volunteer can be considered for a study.
TOP
What happens to me during a study?
Generally, during a study a participant will receive at least two appropriate physical examinations. Some studies require a sample of blood to be drawn at various points in the study and others may require an electrocadiogram to be done. As for the medication or treatment, you might receive the investigational treatment or study drug, or you might receive a “placebo”, an inactive product used to compare with results of the study drug or treatment. Sometimes the investigator will know if you are receiving a placebo, sometimes he/she won’t. Regardless, you will receive the same level of quality medical care from our investigator and staff. While participating in the study you will probably have to keep a detailed diary of events and symptoms you experience over the day and evening. Failure to keep this diary current would cause you to be removed from the study. In addition, you will have to come to our office for examinations and allow us to collect data at least twice. Again, failing to do so would eliminate you from the study.
TOP
What if I’m not happy with the study?
Once in the study, you should feel free to call and talk with your investigator or the support staff at any time. We have a research coordinator who is available each day specifically to help and support our volunteers. As a volunteer, you have the right to leave the study at any time, for any reason.
TOP
How are my records protected?
In all of the studies we supervise, your privacy is protected. As always, all records maintained in our office are confidential. Each participant in each study is identified by a code or number. Access to the research study data is restricted. None of the data sent to the sponsor company or the FDA includes the name or addresses of any of our volunteers.
TOP
How can I participate?
You can call our office during regular business hours at (704) 372-7900 or click here to complete a brief questionnaire and receive a call from our research coordinator.
TOP
|
Home