What is a clinical trial?
Clinical trials are research studies that test how well new medical treatments work in people. Each study addresses specific questions and attempts to find better ways to prevent, screen for, diagnose or treat a disease. Clinical studies may also compare a new treatment to a treatment that is already available.
Each clinical study has a protocol, or action plan, for conducting the trial. The plan describes what will be done in the study, how it will be conducted, and why each part of the study is necessary. Each study has it own rules about who can participate. Some studies require volunteers with a certain disease, while others need healthy participant.
What is expected of patients in a clinical trial?
- Patients in a clinical trial are expected to have eye exams and other tests.
- Patients may also need to take medications and/or undergo surgery.
- Patients will be asked to return for follow-up examinations. These exams help find out how well the treatment is working.
How long will my participation in a trial last?
Trial participation may last a few weeks to a few years. The success of a clinical trial often depends on monitoring the outcomes over a long period of time.
What are the risks?
Clinical trials may involve risks as well as possible benefits.
- Whether or not a new treatment will work cannot be known ahead of time. There is always a chance that a new treatment may not work better than a standard treatment, may not work at all, or may be harmful.
- The treatment you receive may cause side effects that are serious enough to require medical attention.
What are the benefits of participating in a clinical trial?
Participating in a clinical trial can bring many benefits:
- A new treatment may be more effective than the current treatment for an eye disease or disorder.
- The treatment may help to improve vision and control or prevent eye disease or disorder.
- Clinical trial patients receive the highest quality medical care. Experts watch them closely during the study and may continue to follow them after the study is over.
- New knowledge gained from a trial may help other people with the same eye problems.
How is patient safety protected?
Clinical trials can raise fears of the unknown. Understanding the safeguards that protect patients can ease some of these fears.
- Before a clinical trial begins, researchers must get approval from an Institutional Review Board (IRB), an advisory group that makes sure a clinical trial is designed to protect patient safety.
- During a clinical trial, doctors will closely watch you to see if the treatment is working and if you are having any side effects. All the results are carefully recorded and reviewed.
- A group of experts–the Data and Safety Monitoring Committee–carefully watches each clinical trial supported by the NEI. This group can recommend that a study be stopped at any time.
Patients are asked to take part in a clinical trial only if they volunteer and understand the risks and benefits.
What are a patient’s rights in a clinical trial?
Patients who are eligible for a clinical trial will be given information to help them decide whether to take part. As a patient, you have the right to:
- Be informed of all known risks and benefits of treatments involved in the study.
- Know design, duration, and location of the study.
- Know your responsibilities.
- Know any costs involved for you or your insurers.
- Be informed about any medical or personal information that may be shared with other researchers directly involved in the clinical trial.
- Talk openly with doctors and ask any questions.
After you join a clinical trail, you have the right to:
- Leave the study at any time. Participation is strictly voluntary. However, you should not enroll if you do not plan to complete the study.
- Receive any new information about the new treatment.
- Continue to ask questions and get answers.
- Maintain your privacy. Your name will not appear in any reports based on the study.
- Be informed of your treatment assignment once the study is completed.
Our mission is simple:
We want to provide personalized patient care by offering all treatment options and technologies now available. Chu Vision Institute is continuously involved in new and exciting research projects in order to investigate new technologies to help bring them to the market. Since 1996, Dr. Chu has participated in clinical studies in various academic areas of ophthalmology. Click here to go our current clinical trials list.
Only with your help are we able to see into the future of eye care, which will not only impact our local communities’ standard of care, but also influence the standard of eye care for others throughout the nation and around the world.
If you would like more information about participating in research, or to find out if you are a candidate for any of our current studies you can speak to our technical staff during your exam or ask one of our doctors if a study treatment is right for you.
Nic Jacobs, VP Clinical Research and Regulatory
Local | 952.835.1235
Toll-free | 866.400.EYES