Frequently Asked Questions

A clinical trial is a research study that tests new medical treatments, drugs, or devices in human volunteers. These studies help researchers determine whether new treatments are safe and effective. Clinical trials are essential for developing new therapies and improving healthcare for everyone.

People participate in clinical trials for various reasons:

• Access to new treatments before they're widely available
• Receiving care from leading medical specialists at no cost
• Playing an active role in your own healthcare
• Contributing to medical knowledge that may help others
• Compensation for time and travel

Informed consent is the process of learning about a clinical trial before deciding whether to participate. The research team will explain the study in detail, including its purpose, procedures, risks, benefits, and your rights as a participant. You'll receive a written consent document to review and sign if you decide to participate. You can take time to consider, ask questions, and discuss with family members before making a decision.

A placebo is an inactive substance (like a sugar pill) that looks like the study medication but contains no active ingredients. Some studies compare the new treatment to a placebo to measure its effectiveness. Not all studies use placebos—many compare new treatments to existing standard treatments instead. Before you enroll, you'll be told whether the study includes a placebo and your chances of receiving it.

Randomization means participants are assigned to different treatment groups by chance (like flipping a coin). This helps ensure the study results are accurate and not influenced by other factors. You cannot choose which group you're assigned to, but you'll be informed about the possible groups before consenting to participate.

In a double-blind study, neither the participants nor the research team know who is receiving the study medication versus the placebo or comparison treatment. This helps prevent bias in evaluating the treatment's effects. The information is tracked by a code and can be revealed if needed for your safety.

Clinical trials have multiple safeguards to protect participants:

• IRB Review: An Independent Review Board (ethics committee) reviews and approves all studies before they begin
• FDA Oversight: The FDA monitors clinical trials for safety and ethical conduct
• Informed Consent: You'll be fully informed of all known risks before participating
• Ongoing Monitoring: Your health is closely monitored throughout the study
• Right to Withdraw: You can leave the study at any time for any reason

While all medical treatments carry some risk, clinical trials follow strict protocols to minimize risks and protect participants.

Yes, absolutely. Participation in any clinical trial is completely voluntary. You may withdraw from a study at any time, for any reason, without penalty or loss of benefits you're otherwise entitled to. Your decision will not affect your relationship with our practice or your regular medical care.

Yes. Your privacy is protected by federal regulations (HIPAA) and strict research confidentiality requirements. Your personal information is coded and stored securely. Study results may be published in medical journals, but your identity will never be revealed. Only authorized research personnel have access to your identifiable information.

Most clinical trials provide compensation for your time and travel. The amount varies depending on the study requirements (number of visits, procedures involved, etc.). You'll be informed of the compensation details before you consent to participate. Additionally, all study-related medical care and medication are provided at no cost to you.

Study-related procedures, medications, and visits are provided at no cost to you. However, you should continue to see your regular doctors for care unrelated to the study, and those costs would be handled through your normal insurance. We'll clearly explain what is and isn't covered by the study before you enroll.

Yes. Participating in a clinical trial does not replace your regular medical care. You should continue seeing your primary care doctor and any other specialists for your routine healthcare needs. We'll coordinate with your doctors to ensure everyone is informed about your participation.

Study duration varies widely depending on the condition and treatment being studied. Some trials last a few weeks, while others may continue for a year or more. Before enrolling, you'll be told exactly how long the study lasts and how many visits will be required. The time commitment will be clearly explained so you can make an informed decision.

After the study ends, our research team will ensure a smooth transition back to standard care. In some cases, if the study medication proves effective, you may be offered continued access through an "extension study" or "compassionate use" program. You'll also be informed of the overall study results when they become available.

In most cases, you do not need health insurance to participate in a clinical trial. All study-related care is covered by the study sponsor. However, some studies may have specific requirements. Contact us to learn about the requirements for specific studies you're interested in.

Each study has specific eligibility criteria based on factors like age, diagnosis, medical history, and current medications. You can use our online screening questionnaires for a preliminary assessment, or contact our research team directly. If you seem like a potential match, we'll schedule a screening visit to confirm your eligibility through medical evaluation and testing.