Frequently Asked Questions
What is a clinical trial?
The FDA requires that all new medications go through a thorough series of tests before they can be sold. There are many phases of clinical trials that test the safety and efficacy of a drug.
Is it safe to participate?
Although not all of the side effects of new drugs are known, an Institutional Review Board (IRB) must first approve all studies before they can begin. The IRB is a medical research ethics board that makes sure that the rights and welfare of each patient involved in the clinical research trial are protected. The board makes sure that the trial is planned and carried out safely and ethically. All studies must follow FDA regulations and guidelines. During the study, you will be watched closely for your safety. If at any time you feel uncomfortable, or the eye doctor feels that your eye condition may be worsening, you will be taken out of the study immediately. Safety is our first concern and we will not force you to stay in the study. You will get a lot of attention from our study staff, which will give you and the doctor the chance to follow your disease.
Does allergy skin testing hurt or involve needles?
The skin test does not involve needles. We use a small, plastic 4-pronged prick dipped in allergen. This is applied to a spot on your forearm, which is between your wrist and elbow. The prick will only break the top layer of your skin, so that the allergen can get in. After some time, the spot will become red and swollen. We will record the results. The most pain that you will have from the skin test is equal to that of a mosquito bite. We will provide you with a topical cream to relieve your itching before you leave the office.
How long will my participation last?
It varies from trial to trial. Participation can last from 3 visits over the course of a month, to 8-10 visits over the course of several months. Most office visits last between 30 minutes and 2 hours.
Will I be paid for being in the trial?
Yes, you will be paid for your time on a pro-rated basis. Payment varies from study to study based on study procedures and how long you participate in the study.
Will I be taxed for the money?
We are required by law to report earnings over $600 in one year from our studies.
Is there a chance of receiving placebo (an inactive medication)?
This depends on the study. For example, in some studies, everybody receives the active drug, such as a year long glaucoma study. We would not give a patient a placebo to use for a year. However, other studies, such as allergy studies, are planned so that one eye receives active medication and the other eye receives placebo. In most cases, the study is blinded, so the researcher does not know if you received active drug or placebo. Your medical condition is watched closely during the study, so that no problems happen. If you receive placebo, we will put all the related study data in your chart to help your eye doctor follow your disease. If you see another doctor, outside of our group, you may give us his/her name and we will be happy to keep them updated on your progress.
How flexible is the schedule?
We will do the best we can to meet your schedule and not have any conflicts. If you are sick, or are going away for a visit, then most of the time we will be able to work around this. Because of the procedures involved, it may be hard to promise a specific day and time for all of your visits. We always try to keep the patients together the best we can. Our flexibility at our satellite offices depends on the specific doctor. Some may not want to be involved and see patients at extra visits, which means that an ORA team has to travel to the office. However, some of the doctors are very willing to help out when necessary.
Why should I do this - is it a hassle?
We have found that our study patients are very grateful for being in studies. In addition to receiving free treatment, free eye visits, and getting paid, the patients in our studies add to the development of new drugs that will help thousands of patients who suffer from the same condition that you suffer from. Without study patients, the eye drops used each day all over the world would not exist. Also, in a study, you will probably be seen by an eye doctor more times than you would normally, so it is a great chance for you to learn more about your disease and watch its development carefully. Plus, we find that generally our patients have a good time during the study visits.
What if I do not want to participate in a study right now, but I am interested in future studies?
We will keep your name on file, and will call you for future projects.
What kind of tests are involved?
Each test is different for each study and department. Most studies offer full eye tests by licensed eye surgeons and doctors. With these tests, we can watch your eye health carefully. If you are taking part in a glaucoma study, we will check your IOP (Intraocular pressure) regularly, and your visual fields to watch the development of your disease. If you are in an allergy study, you will receive free skin tests to find out what you are allergic to in your environment. In some studies, you will have blood work done that we can send to your doctor at your request. These tests would be a good addition to your medical record.
Will I be able to take my regular medications during the trial? What medications, procedures, or treatment must I avoid while in the study?
There are some medications that you will not be able to use during the trial. These are different for each study based on the condition or disease being studied. Any medications and procedures that may get in the way of the results of the study are not allowed usually. In most cases, there is a washout period for a medication(s), which means that a medication may not be used before the study begins. You will be told about these medications and washout periods before you enter into the study to make sure that you can participate.
Can anyone find out that I am participating in a study? Will my name or medical information be given to anyone?
Your medical record and all other personal information is private, except as required by law. The study doctor, the drug company, and/or its representative will review information that is collected during the study. The drug company, the Food and Drug Administration (FDA), and other government offices will be given a copy of this information as required by law. In addition, the Institutional Review Board (IRB) may look over your records to make sure that your rights and welfare are protected. If the study results are used at meetings or printed in journals, books, or newspapers, etc., your name will never be used. All information that would identify you will be kept private to all organizations, companies, and/or agencies not involved in the trial.