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The Trial Experience

What to Expect as a Participant

If you are interested in participating in a clinical trial, you will go through a series of steps to ensure you match the requirements and to help you make an educated decision about proceeding.

1. Pre-Screen

The research team will first schedule an appointment to learn more about you and provide the preliminary information about the trial. This includes the trial’s purpose, treatment information, the potential benefits and risks, the length of your participation and an overview of the procedures.
If you decide to participate in the trial, you will meet with the research team, learn more about the trial, and have a chance to ask questions. Once you fully understand, you will sign an informed consent form that acknowledges your understanding about what will happen. It also identifies your rights and responsibilities, which include the ability to withdraw from the trial at any time.
During a participant screening, researchers will review your medical history and conduct any other procedures to make sure you meet all requirements for joining the trial.
If you qualify, your participation can begin. Researchers will provide detailed instructions on what you need to do at home, how often you will need to visit the trial site and what will be required at the visits (e.g., physical exams, questionnaires, additional procedures). Your overall health and safety are continually monitored for the duration of the study.
Each trial has predefined study completion criteria. You may also withdraw your consent to participate at any point during the trial to conclude your trial participation. When you complete your trial participation, you may meet with your regular healthcare provider to determine further care options. If you are a healthy volunteer, your commitment is over. Keep in mind that researchers can decide to end trials earlier than expected for a variety of reasons.

What to Expect as a Parent or Legal Guardian

Family decisions about children or others who have legal guardians and healthcare can be extremely delicate. While the reasons and steps for enrolling a family member under your care in a study are similar to enrolling yourself, it is understandable there may be a deeper level of anxiety.

If you are considering enrolling a family member, researchers will outline all aspects of the study including the intervention, benefits and risks, necessary procedures and length of time. If you decide to participate, parents or legal guardians (and the child, depending on age) must sign an informed consent form and, depending on age, the child will provide assent to participate in the clinical trial.

Throughout the study, research team members, including doctors and nurses, will always be accessible to monitor your family member’s health. Remember that participation in the trial is voluntary and that you have the right to stop your child from participating at any time. When the trial concludes, the team will work with your family to coordinate appropriate ongoing care.