Clinical studies help scientists and doctors explore whether a medical strategy, drug, or device is safe and effective for people. Before a new study drug and/or study device can be approved and made available to the public, it must go through phases of clinical research. Each phase helps researchers learn more and relies on volunteer participants.
Before enrolling in a clinical study, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, risks related to participation, the tests and procedures that will occur, and participant responsibilities.
Study participation usually involves visiting a clinic (study site) regularly and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a gene therapy study.
Participation in a clinical research study is your choice, and you may stop at any time. You may be eligible for travel coverage or reimbursement.
