What is a clinical study?
Clinical studies are research trials that determine whether a medical treatment or device is safe and effective. Each study focuses on a specific disease and methods of how to better prevent, screen, diagnose, or treat the condition. A clinical study may also test how well medical treatments work and sometimes may evaluate whether the technology used is superior to existing technologies.
Why participate in a clinical study?
Patients typically choose to participate in a clinical study because they may benefit from new treatments or technologies being studied. Patients who participate also benefit from being a part of the future of ophthalmic treatments that may help generations to come.
What is expected of patients who participate in a clinical trial?
Patients are expected to have eye exams and other tests, may need to take medications and/or undergo surgery, and will be asked to return for follow-up examinations which may vary depending on each clinical trial. The follow-up exams will help determine how well the treatment is working.
Is study participant medical information kept confidential?
Patients are identified in clinical studies by study numbers instead of names. Personal information like names or addresses are not disclosed. The medical information thus collected with a study identification number will be available to the study sponsor and government oversight agencies that are involved in the evaluation of investigational devices and procedures.
How long will the clinical study last?
The duration of a clinical study varies and may last a few weeks to a few years. The success of a clinical study often depends on monitoring outcomes over an extended period of time.
What are the benefits of participating in a clinical study?
There may be benefits associated with participating in a clinical study, some include:
- Access to a new treatment method that may not otherwise be available to the public
- Highest quality of care from experts who closely monitor a patient’s medical condition during the study and may continue care after study is completed
- New knowledge surrounding the studied disease state or technology that may help others
What are the risks involved in a clinical study?
It’s important to remember that whether or not a new treatment will work cannot be determined ahead of time. There is always a chance a new treatment may not work better than an existing treatment, may not work at all, or may be harmful. Some clinical study treatments may also cause side effects; some serious enough to require medical attention. Talk to your doctor for more information on the possible side effects involved with a particular clinical study.
Will my insurance cover costs related to being involved in a clinical trial or will I need to cover any costs?
Patients will not be charged for study-related visits before and after surgery. Patients typically have no out-of-pocket expenses for the study device or the study procedure. Patients and their insurance company may be billed in the usual manner for the costs of medications; health insurance may or may not pay for these charges.
Before agreeing to be in a clinical study, if there are costs associated with the study, patients should contact their healthcare payer/insurer to see if their plan will cover these costs.
How is a patient’s safety protected while participating in a clinical trial?
Before a clinical trial begins, researchers must obtain approval from the Institutional Review Board (IRB), whose responsibility it is to protect a patient’s care and rights. During the clinical trial, doctors will closely monitor a patient’s treatment to see how it’s working and if any side effects occur.
What are a patient’s rights in a clinical trial?
As a participant in a clinical study, patients have the right to:
- Be informed about the study information and purpose
- Be informed about the medications or devices used in the study
- Have patient responsibilities thoroughly explained before and during the study
- Have possible benefits, risks, dangers, and discomforts thoroughly explained before and during the study
- Be informed of the benefits and drawbacks of alternative drugs or devices before and during the study
- Be informed of medical treatment options should patients need medical attention due to a direct result of the clinical study
- Have the opportunity to ask questions regarding the clinical study
- Stop involvement with the clinical study at any time without affecting treatment in the future
- Be given sufficient time to decide whether to participate in the study without feeling pressured
- Maintain privacy by not having a participant’s name printed on the study
- For studies involving different treatment groups, be informed of the treatment assignment once the study is complete
- Be given a signed copy of their consent form
Can participants in clinical studies choose to quit the clinical study if they choose to?
Potential risks, benefits, study duration and time considerations of being involved in clinical trials will be discussed with patients in advance and should be considered when choosing to enroll in a clinical study. Ultimately, some patients are not able to fulfill the commitments of being involved in a clinical study and may choose to leave the clinical study.