Question 1

What are clinical trials?

Accepted Answer

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.

Question 2

Why should I participate?

Accepted Answer

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.
 
Participants will also receive study medication and study-related medical evaluations at no cost.

Question 3

Do your studies involve a placebo treatment or a medication already on the market?

Accepted Answer

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).

Question 4

What is an investigational drug?

Accepted Answer

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.

Question 5

How do I know if I qualify for a research study?

Accepted Answer

To see if you may qualify for one of our enrolling studies, sign up using the form in our "Participate" page or give us a call at 714-289-1100 and one of our recruitment coordinators will reach out to you!

Question 6

How long will the studies last?

Accepted Answer

The length of each research study varies. Our study coordinators will inform you of the length of the research study prior to your participation.

Question 7

What are my responsibilities as a patient?

Accepted Answer

As a patient, your responsibilities are to comply with all study procedures, come to regular visits, and take study medication.

Question 8

What are common study procedures?

Accepted Answer

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.
 
Some research studies may also require brain scans and other additional examinations, such as chest X-Rays, ophthalmology exams, and lumbar punctures.
 
A list of common procedures involved when participating in a clinical trial can be found here.

Question 9

Do I have to pay for any part of the study? Will my insurance cover the costs?

Accepted Answer

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.

Question 10

Will I be paid for my participation in a research study?

Accepted Answer

Yes - you will be compensated for time and travel for every study visit you complete. The compensation amount will vary from study to study. 
 
Additionally, transportation may be provided free of charge for those who require assistance.

Question 11

What is informed consent?

Accepted Answer

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. 
 
The informed consent form is not a contract, and you may withdraw from the research study at any time.

Question 12

What will you do with my medical information? Who will know about my participation?

Accepted Answer

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.

Question 13

Will I be able to continue seeing my own doctor?

Accepted Answer

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.

Question 14

What are the risks of participating in a research study?

Accepted Answer

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.

Question 15

Can I withdraw from a study at any time?

Accepted Answer

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.

Question 16

What will happen to my medical care if I participate in or withdraw from a study?

Accepted Answer

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.

Question 17

Do I have to discontinue my current medication if I decide to participate?

Accepted Answer

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.

Question 18

If I am under 18, do I need my parents' permission to participate?"

Accepted Answer

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.

Question 19

If the treatment works for me, can I keep using it after the study has ended?"

Accepted Answer

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.

Question 20

Who oversees your studies?

Accepted Answer

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.

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