Clinical Studies and Research

Clinical trials are research studies that test how well new medical treatments work in people. Each trial addresses specific questions and attempts to find better ways to prevent, screen for, diagnose, or treat a disease. Clinical trials may also compare a new treatment to a treatment that is already available.

Each clinical trial has a protocol, or action plan, for conducting the trial. The plan describes what will be done, how it will be conducted and why each part of the trial is necessary. Each trial has its own rules about who can participate. Some trials require volunteers with a certain disease while others need healthy participants.

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.

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.

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. The new 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.

All known potential risks for a certain therapy will be disclosed before the patient consents to participate in the 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.

Patients are asked to participate in a clinical trial only if they volunteer and understand the risks and benefits. 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 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 your 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 questions.

After you join a clinical trial, 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.