Clinical trials 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.
Watch this video to learn more about clinical trials.
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the trial, including trial goals, how long the trial will last, risks related to participation, the tests and procedures that will occur, and participant responsibilities.
Watch this video to learn more about ICFs.
Trial participation usually involves visiting a clinic (trial site) regularly and having assessments to monitor your health. You can still see your regular doctor (or other health care provider), but you should let them know that you are participating in a gene therapy trial.
Participation in a clinical research trial is your choice, and you may stop at any time.
Watch this video to learn more about what to expect once enrolled into a study.