Here are some common questions and answers about study participation.
Clinical research studies help scientists and doctors explore whether an investigational medicine (also referred to as “study drug”) is safe and effective. Before a doctor can prescribe a drug for a specific condition, the investigational medicine must go through several phases of research and be approved by a health authority, such as the Medicines and Healthcare products Regulatory Agency (MHRA). Clinical research is only possible with the help of volunteers who participate in the studies. Participation is a choice, and volunteers may stop participating at any time without giving any reason. The rules and ethics that doctors must follow to practice medicine also apply to clinical research studies. Additional standards called Good Clinical Practice also apply.
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive.
Study participation usually involves visiting your study doctor at the clinic regularly, taking or receiving an investigational medicine, and having assessments (i.e., eye exams and blood tests) to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.
Participation in clinical research studies is your choice, and you may stop at any time.
If you have additional questions about participating in a clinical research study, contact a study clinic near you.