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Can I see my regular doctor, or other doctors, during the clinical trial?

Yes, you can visit any doctor to meet your health needs during the clinical trial. You should let your study doctor know that you will be seeing another doctor and if any other medication has been prescribed. You should also let your other doctors know that you are participating in a clinical trial.

What if I have questions during the trial?

You can ask your study team questions at any time before, during, and after the FUSION study. Before agreeing to participate, the study team will review the Informed Consent Form (ICF) to help you understand what participation in the study will involve. If you have any concerns about participating in the clinical trial, you should feel comfortable discussing them with a member of the study team at any time.

Is there a cost to participate in the study?

There is no cost associated with participation in the study. Travel expenses (such as transportation and hotel, if required) will be provided. You may also be reimbursed for certain travel expenses.

Are clinical trials safe?

There are always risks involved in participating in clinical studies. The side effects of new drugs or devices are not fully understood, which is part of the reason the research is being done. However, clinical study protocols are carefully controlled and designed to monitor the safety of all the participants. In addition, investigational drugs and devices go through extensive pre-clinical testing before they even make it into a clinical study. All clinical study protocols must be reviewed by an Institutional Review Board, or IRB, which may be comprised of doctors, nurses, and/or medical ethics experts, whose job it is to review the study and ensure the potential benefits outweigh the risks.

Why do people participate in clinical trials?

Participating in a clinical study allows researchers to gather valuable information about potential new therapies for medical conditions. In some cases, the medical conditions are extremely rare and have limited or no available treatments. Participating in a clinical study may enable a patient to take a more active role in their own healthcare or a chance to gain access to new investigational drugs or devices before they are available, and the information gathered from these studies may help others with the same disease or condition in the future.

What is a clinical trial?

A clinical trial is a medical research study designed to assess whether or not a new drug or treatment is well-tolerated and effective in treating ­people with a particular disease.