What do I have to do as a study participant?
As a participant in the NEW-HOPE study, you will need to:
- Go to all scheduled visits at the scheduled time
- Take the study investigational drug as directed
- Participate in all study procedures
- Tell your study doctor before taking any new medications
- Tell your study doctor about any illnesses or injuries
- Tell the study doctor about any side effects or problems that occur during the study
- Tell the study doctor if you plan to have any surgery or any other medical treatment or procedures
What are the risks and benefits to me by participating in this study?
With any clinical study, there are potential benefits and risks for participants. Your study doctor will review these with you thoroughly prior to the start of your study participation. All known potential side effects are listed in detail in the Informed Consent Form. It is important to keep an open conversation throughout the study with the study doctor and/or nurse if you have any questions about risks or benefits of participation. You should only enroll in the study after careful consideration and discussion with a study doctor.
Some potential benefits of participating in this study include:
- Access to study investigational drug
- Education about your condition
- Close monitoring and extra care by a healthcare team experienced in clinical studies
Some potential risks of participating in this study include:
- Potential to experience side effects from study investigational drug, ranging from mild to serious
- No improvement or potential worsening of your condition
- Facing risks that are not yet known
Can I withdraw from the study?
Participation in this study is voluntary, and you may stop participation at any time. If you do choose to withdraw from the study, notify your study doctor immediately and follow instructions so that your safety can be monitored as you stop taking the study medication.
How will my personal information be kept confidential?
The collection of personal information for this study is limited to what is needed to study the study medication. With your permission, we will process your information to ensure confidentiality per local law. Your identity will remain confidential. You have the right to request confirmation of the existence of your personal information held and to correct any inaccurate information until the end of the study.
Will I be paid to take part in this study?
Reimbursement for your time and travel will be explicitly described in the Informed Consent Form and will be reviewed with you by your study staff.
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