Why are clinical research studies conducted?
Clinical research studies help scientists and doctors explore whether investigational drugs can treat diseases in patients. Before a new medicine can be approved for treating a specific condition, it must go through several phases of research, including human clinical studies.
What is an “investigational” drug?“Investigational” means that a drug is still being studied and has not been approved by any regulatory authority. The U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other regulatory authorities do not allow investigational drugs to be sold for the treatment of patients. Investigational drugs can only be used for research use.
Why do people participate in clinical research studies?
People participate in clinical research studies for a variety of reasons. Some participate to learn more about their disease/condition or obtain a potential health benefit. Others participate to help physicians learn more about the disease/condition, as well as others with the same disease/condition in the future.
Are clinical research studies safe?
Clinical research studies follow a specific set of standards and are closely regulated to help ensure the health, safety and well-being of all participants. Studies follow a written plan called a protocol. The protocol is reviewed and approved by an Institutional Review Board, which is a group of people responsible for ensuring that the trial is conducted according to certain ethical standards and for protecting the safety and rights of research subjects. Before you participate in any clinical research study, you will review the study requirements, as well as potential risks and benefits of participation in the study, and the study staff will be available to answer any questions you may have. You will also be asked to review and sign an informed consent form, giving you detailed information about the study and securing your consent to obtain and use your data from the clinical study.
What if I have questions during the study?
You can ask questions of the study team at any time before, during, and after the study. Before agreeing to participate in the study (as a participant or caregiver), please make sure you understand the responsibilities of study participants and caregivers. If you have any concerns about participating in the study, you should feel comfortable discussing them with a member of the study team at any time.
Can participants leave the study once it has started?
Study participation is completely voluntary. You do not need to take part in the study, and you can end participation at any time, for any reason or no reason at all. If you want to stop participating in the study, talk to the study doctor. If you decide that you (or your loved one) should leave the study early, the study doctor may ask that the study participant returns to the study site for a final visit to review his/her health and safety, but there will be no negative impact on the care received.
Can participants see their regular doctor, or other doctors, during the study?
You can visit any doctor for your health needs during the study. You should let your study doctor know about the other doctors and if any other medication has been prescribed. You should also let the other doctors know about the study.