Is being a volunteer in a clinical trial a reasonable option for you? Your decision is an important one, both for yourself and others
who may be living with your same eye condition. You owe it to yourself to learn everything that's involved.
Clearly, there may be some risks to participants in a clinical trial. But the federal government (Food and Drug Administration —
FDA) has imposed mandatory safeguards and regulations, which serve as guidelines for doctors to follow. Our doctors have made a commitment
to ensure your safety is not put at risk by following all FDA guidelines. Additionally, an Institutional Review Board (IRB) or Ethics Committee,
an objective group of independent experts, supervises all of our trials. The board first must approve the trial, and then monitor its operation
ensuring that risks are as low as possible, and worth the potential benefits.
Questions that you should ask before participating in any trial:
- What is the purpose of this trial?
- Who will benefit from this trial?
- What are the advantages of clinical research?
- How many people can be helped by the results of this trial?
- How long will the study last?
- How often will I have to visit the clinic?
- How long will the visits last?
- How will this study affect my daily life?
- If the trial is not fitting into my lifestyle, can I back out?
- If I back out or discontinue participation, will I face any penalties or be denied medical treatment otherwise?
- Can I take my prescriptions or over-the-counter medications, along with the study medication?
- Will there be any cost to me?
- Will I receive any compensation for participating?
- Where is the study being conducted?
- How will my privacy be protected?
- What types of activities will I need to do at home, such as giving myself an injection, or taking my own blood pressure, or keeping a journal?
- What treatments will be used and how?
- What procedures will be done?
- What are the potential benefits?
- What are the potential risks?
- Do the potential benefits outweigh the potential risks?
- What are the potential side effects?
- Is it true that I might receive a placebo-such as a sugar pill?
- If I'm ill, what is likely to happen to my disease symptoms with or without this study medication?
- How do the risks of the study drug compare to alternative treatments?
- How will my safety be monitored?
- Who has reviewed and approved this study?
- Who has continuing oversight of the study, to protect my welfare?
- Whom do I contact if I experience adverse effects?
- Whom do I contact with questions about my rights?
- Have you had difficulty attracting participants for this trial?
- How experienced is this organization (hospital, research firm, etc.) in conducting clinical trials?
If you have further questions, or are interested in taking part in one of these clinical trials, contact Stephen Infantino, Director of Clinical Research
at steve@eyecenters.com or (502) 214-3397.
