What is a clinical trial?
A clinical trial is a research study designed to answer specific questions about investigational drugs or devices. Studies are conducted according to Food and Drug Administration (FDA) regulations and Good Clinical Practices. All study participants are volunteers.
Who can participate in a clinical trial?
People with the condition being studied can volunteer to participate in a study. Each clinical trial has its own particular requirements as well as its own eligibility criteria. The physician conducting the study will review each volunteer’s medical history and the study requirements to determine who can participate.
What are the benefits to me of participating in a clinical trial?
Each year, thousands of people volunteer to participate in a clinical research studies. Benefits to you as a volunteer may include:
During the course of the clinical trial study, all study-related medication, laboratory tests, diagnostic procedures and study-related examinations will be provided at no charge to you.
You will have expert medical care for your condition, illness or disease.
You can learn valuable education about your condition, illness or disease.
Having the satisfaction of knowing that you are helping in the development of medical treatments that may help others.
Each study participant will also receive reimbursement for time and travel.
If I agree to participate in a clinical trial, what are my obligations?
As a volunteer for a clinical trial, you are agreeing to provide your time and attention to a very important medical research project. If you determine that you do not have the time to participate in a clinical trial, you may leave the study at any time for any reason. We will ask you to return any unused medication and contact our personnel to have a final visit.
Why should I participate in a clinical trial?
You have the opportunity to participate in an investigational treatment before it becomes widely available. You may benefit from an alternative course of treatment that you or your physician might not otherwise have known about. You will receive expert medical care during the clinical trial. Also, you can help others by contributing to medical research.
Are there any risks to participation in a clinical trial?
Researchers, doctors, and other health professionals conduct research studies according to strict rules set by the Food and Drug Administration (FDA). The FDA created these rules to protect clinical trial participants and to make sure they are treated as safely as possible. Research studies are also overseen by medical ethics groups to ensure that study participants are treated appropriately.
Some study medications may have side effects that can be unpleasant, serious or even life-threatening. The risks will be fully explained to you before you begin the clinical trial procedures.
What is the Informed Consent?
Informed consent is the process designed to give volunteers the information that they need to decide about participating in a clinical research study. The informed consent describes what you can expect from your participation in the study such as the frequency of the study visits, what procedures will be done during the study, any potential benefits and possible risks of participating in the study. It is very important that you take your time and read the informed consent document carefully. If you have any questions regarding the document, you should discuss them with the study doctor and study coordinator. Once you are satisfied that you understand all of the information given to you and that all of your questions have been answered, you will be asked to sign the informed consent document.
How does a research study work?
After signing the informed consent, information will be obtained from you to see if you meet the requirements for study enrollment. Once eligibility is confirmed you will be enrolled in the study. Each study has different requirements, but generally during the study you can expect:
• To be assigned to a group that is given the study drug or to a group that is given a placebo (an inactive product, like a sugar pill).
If I have questions about the clinical trial, whom do I call?
Each clinical trial study participant is provided with an on call phone number. The research team is available 24 hours a day, seven days a week, and 365 days a year.
How my privacy is protected?
Where can I get more information about research studies?
There are several organizations that offer information about research studies. Here are a few:
A&O Research Center
8774 SW 8 Street
Miami, Fl 33174