Participating in a Clinical Trial
What is expected of volunteers in a clinical trial?
Participants in a clinical trial are expected to receive eye exams and other testing. You may need to take a new medication or undergo a new surgical procedure during the study. You may also be required to return to the medical facility for follow-up examinations. These exams help determine how well a treatment is working. Such follow-up studies can last for months or even years.
The success of a clinical trial often depends on learning what happens to participants over a long period of time. Only participants who continue to return for follow-up examinations can provide this important long-term information. These exams are essential for the success of the study. You should consider this when you are deciding whether to participate in the clinical trial. The study results will not be valid unless almost everyone who enrolls in the trial participates in the follow-up exams.
What are the benefits of participating?
Participants in NEI studies are monitored by a team of expert doctors, nurses, technicians, and support staff. By participating, you may be one of the first people to receive a promising new treatment. If the treatment is effective, it may improve your vision or prevent an eye condition from occurring.
If you are in the control group and the treatment is found to be safe and effective, you may be among the first to benefit from the treatment when the study ends. All participants in clinical trials contribute to new knowledge that may help other people who experience similar eye problems. If you have an eye condition that runs in your family, your participation may also lead to better care for your family members.
What are the risks of participating?
Medical professionals have no method for predicting if a new treatment will work in a particular person. The treatment you receive could cause side effects that are serious enough to require medical attention. Participants must understand that a new treatment may not work better than a standard treatment, may not work at all, or may be harmful.
What if a volunteer’s health changes unexpectedly during the study?
Your health is unpredictable. You could develop a serious medical condition during the study that is completely unrelated to your vision. If this happens, doctors may determine that it is in your best interest to leave the study. Your overall health always comes first in a clinical trial.How is patient safety protected?
Before a clinical trial begins, researchers must get approval from an Institutional Review Board. This independent advisory group makes sure that a clinical trial is designed to be scientifically correct and to protect patient safety.
During a clinical trial, doctors will closely monitor you to see if the treatment is working and to identify any side effects. All of these observations are recorded and reviewed. In addition, an independent group of experts known as the Data and Safety Monitoring Committee carefully monitors every NEI-supported trial. This group can recommend that a trial be stopped if the risks outweigh the benefits for participants or if the new treatment is so effective that it could be used by everyone as soon as possible.
What are the costs of a clinical trial?
All medical care provided at the NEI medical facility in Bethesda, Md., is free of charge. Clinical trials conducted at other locations may involve costs related to standard medical care. These may or may not be covered by health insurance. You should discuss any possible costs with your healthcare provider and insurance company before enrolling in a clinical trial.