What are Clinical Trials Like at the Retinal Research Institute?
If you have been approached to be in a clinical trial at Retinal Consultants of Arizona’s Retinal Research Institute, you probably have many questions about what is involved. You may be nervous about the study procedures, or what the study drug is, and its side effects. You may be concerned about making it to all your study visits.
Please review the FAQ below for answers to commonly asked questions regarding clinical trials at the Retinal Reseach Institute.
What is a clinical trial?
A clinical trial is a research study in which volunteers receive investigational treatments under the supervision of a physician and other research professionals. The treatments are developed by pharmaceutical and biotech companies (“Sponsors”) who select qualified doctors and staff members to conduct the research, who help to determine the benefits of the investigational product. The US Food and Drug Administration (FDA) must review and approve a clinical trial prior to its start to ensure that the trial is valid and that the potential benefits of doing the trial outweigh the risks to which participants are exposed.
Am I going to be treated like a “guinea pig”?
No, you will not be treated like a guinea pig. When participating in a research study, you will receive the highest standard of care available. A licensed physician will evaluate you regularly for your medical condition. Our staff will strive to make your visits comfortable and pleasant. You will be assigned to work with a trained Research Coordinator to accompany you during all of your visits.
Who can participate?
Any volunteer that qualifies for the study is allowed to participate. All studies have entry criteria that you must meet in order to be enrolled; these criteria vary widely from study to study and are designed to make sure that the data produced by the studies is useful.
How does the trial work?
A volunteer is usually assigned to a specific study group. Volunteers in one study group may receive an investigational treatment or study drug while other volunteers will receive the current standard of care. In some studies, the volunteer, participant, doctor, and the research staff may not know who is receiving the active treatment. This allows the doctor to objectively observe the volunteers during the study. Regardless of which treatment volunteers receive, the level of attention and medical care provided will be the same.
What can be expected if I choose to participate?
If you agree to participate in a clinical trial, you must be “screened” to make sure you qualify for the study. The Research Coordinator schedules this screening appointment with you.
Once all screening procedures are performed and the study doctor and Sponsor of the study have all the information needed to verify your eligibility for participation, then you may be enrolled into the clinical trial.
Since every study will be different, a detailed description of what’s expected of volunteers will be outlined in an Informed Consent Form that is provided to you by research staff. The information listed in this form will also include specific information regarding the study. Generally you can expect to have several visits throughout the period of the research study.
A typical study visit includes a visual acuity assessment, an assessment of an illnesses or changes in medications since your last study visit, measurement of the eye pressure and dilation of the pupils, and an eye exam by the physician.
Depending upon the study, the investigational medication being studied may be an injection into the eye, a medication that is given orally, or a medication that is given in the form of an eye drop. This varies widely by study, so be sure to ask your Research Coordinator or doctor if you have any questions.
Do I have any other choices?
Since participating in a Research study is voluntary, you have other choices.
You may choose:
Not to join the study;
See if you may qualify for another study;
Investigate other possible treatments;
Continue to get regular care from your physician
What are the possible advantages for being in a study?
Study participants will be closely monitored for any medical changes in their condition. Study participants will receive a full, comprehensive, medical evaluation prior to participating in a research study, often at no cost to the study participant. Other benefits include a contribution to the addition of new treatments that may help others with similar diseases.
Does information remain confidential?
Appropriate care will be taken to maintain the confidentiality of your medial records and personal health information. Access to personal information is usually available by the doctor and the research team conducting the study. To help keep your information private, your name will not be used whenever possible. In some cases, the Institutional Review Board overseeing the research, study sponsor, and the researchers will have access to personal information along with some government agencies. This information is explained more in the consent form provided for the study.
What happens after the trial?
After the clinical portion of the study is complete, the data collected will be analyzed to determine the drugs effectiveness, if it is safe, and if there are any side effects. If your condition continues, you will continue to receive the standard of care treatment that your doctor recommends.