Clinical Trials FAQ
Many of the conditions we treat have well-established and effective treatments. Some of these treatments work well, but we are constantly trying to improve upon them. For other conditions, effective treatment is not available. At the Retinal Consultants, we always want to bring you the best care possible, and this includes participating in well-designed research studies to advance medical care.
Studies vary in the number of patients that take part. Some studies require only a few dozen patients and others require hundreds or even thousands. Statistical analysis determines the number of patients required to satisfactorily answer a research question. Only a small percentage of our patients qualify and volunteer to participate in research studies. These patients are often combined with patients from other research centers across the country to achieve the required number of patients to conduct the study.
If you agree, you will be carefully screened for your eligibility to participate. This usually involves a careful eye examination and supplemental diagnostic tests. In most cases, these are the same tests that would be required for your care regardless of your participation in a research study. However, because of the demands of research, testing for studies must be done in a standardized way and this may take additional time. In some cases, the interview and examination to determine your eligibility to participate in a research study will occur at a separate visit on a different day than your clinic appointment.
The length of time you will be asked to participate in the research study will depend on the specific study for which you qualify. Some studies require as little as a few months of participation while others ask that you participate for over a year. If you agree to participate in a study, we encourage you to remain a participant for the planned duration of the study.
Yes. You can decide to stop at any time. Just tell the study researcher or staff person right away if you wish to stop being in the study. However, the benefits of the study are greatest when patients participate for the duration of the study.
Also, the study researcher may stop you from taking part in this study at any time if he or she believes it is in your best interest, if you do not follow the study rules, or if the study is stopped.
At our practice, we carefully select the studies we run for safety and responsibility. The object of research is to learn and to develop better treatments, and the outcomes of the study are not known at the start. However, we only participate in research where we feel that the scientific basis is solid. Our goal is to only participate in studies where study participants have the potential to receive more advanced care than is available outside the study. The specific risks or side effects for each study are different and will be discussed in detail with you by one of the research staff before you agree to participate. Often the most significant “side effect” of participating in the study is that you may be asked to have more frequent or longer clinic visits to allow for the study examination and treatments.
In most cases, participation in the study will make you eligible to receive exams and treatments at no cost or a reduced cost to you or your insurance.
Participation in a study may also allow you to receive a new treatment before it is available to the general public. In many cases these treatments are not available to patients who do not participate in the study.
Additionally, study patients are monitored very carefully, often with additional testing that is more than the usual for other patients with similar conditions. This intensive monitoring is provided at no additional cost to you or your insurance.
The greatest benefit of participating in the study may not be to you directly. Previous participants in studies have allowed us to provide the modern treatments we now have available. Your participation as a research subject will benefit future patients with your condition.
You are free to choose not to participate in the study. If you decide not to take part in this study, there will be no penalty to you. You will be treated with the same high standards of care we offer to all of our patients. The most advanced treatments available outside of research studies will be available and offered to treat you.
We do our best to make sure that the personal information gathered for any study is kept private. However, we cannot guarantee total privacy. Your personal information may be given out if required by law. If information from this study is published or presented at scientific meetings, your name and other personal information will not be used.
Most studies offer compensation for each completed visit. However, in the rare case that they do not, these details will be reviewed with you before you agree to participate.
Taking part in this study is your choice. You may choose either to take part or not to take part in the study. If you decide to take part in a study, you may leave the study at any time. No matter what decision you make, there will be no penalty to you in any way. You will not lose any of your regular benefits, and your rights as a patient in our practice remain unchanged.
You can talk to the doctors or the research staff about any questions, comments, or concerns you have about participating in a research study.