What are clinical trials?
Clinical trials are research studies performed on human participants that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or medical device, is safe and effective in people. They are meant to find new or improved methods of evaluating or treating a condition.
What are common study procedures?
Common study procedures include an initial interview with our physician, psychiatrist, or psychologist about your mental and physical health, physical examinations, vitals, electrocardiogram (ECG), blood draws, urine specimen, neurocognitive testing, and health checks.
Who oversees your studies?
Both the Food and Drug Administration (FDA) and Institutional Review Boards (IRB) oversee all of our study protocols. These institutions approve, monitor, and review our research studies to ensure that the rights and welfare of the subjects are protected.
Do I have to pay for any part of the study? Will my insurance cover the costs?
No - all study-related medical care and study medication will be provided at no cost. We do not require health insurance. Additionally, transportation may be provided free of charge for those who require assistance.
Can I withdraw from a study at any time?
Yes - your participation in any research study is completely voluntary. You may refuse to participate or discontinue participation at any time without any penalty or loss of benefits.
What is informed consent?
Informed consent is the process where a participant is informed about all aspects of the trial, which are important for the participant to make a decision. After studying all aspects of the trial, the participant will voluntarily confirm his or her willingness to participate in a clinical trial. No study-related procedures can take place before you have signed the informed consent form.
Will I be paid for my participation in a research study?
Yes - you will be compensated for time and travel for every study visit you complete. The compensation amount will vary from study to study.
What will you do with my medical information? Who will know about my participation?
The information you provide, and your participation will not be shared with anyone who is not directly associated with this research study without your permission (except as required by law) or as set forth in the informed consent.
What is an investigational drug?
Also called an experimental drug, an investigational drug is a substance that has been tested in the laboratory and has been approved by the U.S. Food and Drug Administration (FDA) for testing in people. Clinical trials test how well investigational drugs work and whether they are safe to use.
What are the risks of participating in a research study?
As with any medication, there are possible side effects associated with each investigational medication. Additionally, your symptoms may not improve or may get worse during the research study. Our doctor or study coordinator will discuss all of the possible risks and potential benefits in detail with you.
How do I know if I qualify for a research study?
If I am under 18, do I need my parents' permission to participate?
Yes, you will need a parent/guardian's persmission to participate, and they must be willing and able to accompany you to all study visits.
Do I have to discontinue my current medication if I decide to participate?
Some research studies may have excluded medications. We encourage you to discuss any changes to your medical care with your doctor prior to making any decisions.
Why should I participate?
Clinical trials are part of clinical research and at the heart of all medical advances. Participants can help shape future treatment, and may receive compensation for time and travel.
Do your studies involve a placebo treatment or a medication already on the market?
The type of treatment involved with each study is different - some will involve a placebo treatment, some will involve an Investigational Medication, while some will involve a medication already approved by the Food and Drug Administration (FDA).
How long will the studies last?
The length of each research study varies. Our study coordinators will inform you of the length of the research study prior to your participation.
Will I be able to continue seeing my own doctor?
Yes, you will be able to continue seeing your own doctor throughout the duration of the research study. You may also talk with your doctor to help you make your decision about participating in a research study.
What are my responsibilities as a patient?
As a patient, your responsibilities are to comply with all study procedures, come to regular visits, and take study medication.
If the treatment works for me, can I keep using it after the study has ended?
Some clinical trials offer open-label extension studies after the core study has been completed. During which all participants will take the investigational medication (meaning no one will be taking placebos). The length of each extension study varies.
What will happen to my medical care if I participate in or withdraw from a study?
Your medical care will not be affected by your participation in or withdrawal from any research studies. There will be no penalty or loss of benefits to which you are entitled.