Retinal Research Frequently Asked Questions
Here are some common FAQs on participating in research and clinical trials at Austin Retina Associates:
There are a few notable benefits for clinical research patients. First, you potentially have access to medications that work as well as, or perhaps better than, standard-of-care therapy. If no treatment currently exists for your condition, a clinical trial can be an option to get access to some kind of treatment in the hopes of improving your outcome. Second, given that our research patients are potentially being given experimental treatment, their health is followed extremely closely. Not only will we be thoroughly examining your eyes from visit to visit as we would in clinic, but we will also be checking bloodwork and other markers that can give you more information about your overall health.
There are many reasons that people choose to participate in a clinical trial. Some like the idea of receiving alternative therapies, or the possibility of getting treatment where none currently exists. Others like to contribute to the scientific advancement of healthcare in the hopes that family, friends, and others may benefit in the future. Ultimately, a clinical trial is a potential option that you will need to evaluate for your own situation.
This will be different for every person as this is something for patients and their family to decide for themselves. The physicians at Austin Retina Associates will only recommend a clinical trial to you in the event that they believe it is a good option for you to consider. We will discuss all the details and answer any questions you may have.
If you are potentially eligible for a clinical trial, we will speak to you about all of your treatment options. If you are not interested in participating in the study, you will still receive excellent care in our clinic.
Before answering this question, it is first important to state that our research staff are employees of Austin Retina. We are here to make sure that you, the patient, is receiving the best care possible. Although we provide data for clinical trial sponsors, all staff at Austin Retina, including the research team is here for the patient first. The person who is ultimately responsible for your care during a clinical trial is the physician who sees you for your study visits. When you are enrolled in a study, the plan is for the physician and research staff to follow all scheduled assessments and treatments as outlined in the study protocol which is designed with input from the FDA and IRB to ensure that patients are safe and receive adequate care similar to a patient who is not in the study. Although the study doctor follows this protocol, which should benefit the typical patient with a given retinal disease, if it is ever necessary to deviate from the protocol or remove a patient from a study we will always do what is best for our patient. It is also important to remind you that a patient can leave a study at any time if they feel that they are not satisfied with their participation.
Usually all costs associated with your care during your participation in a clinical trial are covered by the study sponsor. One potential exception is if your non-study eye requires treatment. Sometimes a study will cover the cost of caring for both eyes, sometimes it will only be the eye enrolled in the study.
Yes, you can decide to quit participating in a study at any time, however we would ask that you come in for a final visit so that we can collect all necessary data.
No, there is no contract, and you may leave a study at any time.
In the cases of some retinal problems, no FDA-approved treatment option exists. In situations like this, an experimental therapy must demonstrate that its benefits outweigh any potential risks when compared to no treatment at all. Most of our clinical trials do not have a placebo group, but in certain studies it is ethical and necessary.
Clinical trials can last anywhere from one visit to 5 years or more. Most clinical trials conducted at Austin Retina range from about 6 months to 2 years.
Austin Retina is committed to protecting your privacy. When you participate in a study, you are typically assigned a subject number. All of your health information and diagnostic results are then reported to the sponsor associated with your subject number and not your name/date of birth. This protects your health information from being tied to your identity anywhere except here at our office. We take privacy extremely seriously at Austin Retina and have many policies in place to keep your health information safe.
