Clinical research studies, also called clinical trials, are studies in which participants are asked to take a study drug under the supervision of a physician and other research professionals. A study drug is one that is not approved by a health authority, such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA).
Clinical research studies must be reviewed by an institutional review board (IRB) or ethics committee (EC). An IRB or EC is a group that is responsible for helping to protect the rights and welfare of study participants. In addition, every study participant is monitored with study-related medical tests and exams before, during, and sometimes even after the study.
Governments and sponsor companies (such as pharmaceutical or biotechnology companies) typically run clinical research studies. They are responsible for creating a strict study protocol (a written description of the research study) and ensuring that all people involved follow it throughout the course of the study.
Before you participate in a clinical research study, a detailed description of the study, as well as possible risks and benefits, will be provided in writing in an “informed consent form” and discussed with you. You will be asked to review and sign the informed consent form prior to participating to show that you understand the study and its possible risks and benefits.
If you qualify, you may be enrolled in the clinical research study. Once enrolled, feel free to discuss your research care with the study doctor or study team members at any time during the course of your study participation. It is important for you to:
As a study participant, you will have the right to contact the study’s IRB or EC representative regarding your rights as a research participant. You will also have the right to leave the study at any time for any reason.
Participation in any clinical research study is completely voluntary, and participants may withdraw from a clinical research study at any time for any reason without penalty or loss of medical care or benefits to which you are entitled. If you would like to leave the study, you should discuss this with your study doctor, who will give you information about how to do this safely and make arrangements for further medical care and follow-up.
Generally, at the end of a study, researchers analyze and compare the data collected from all participants. De-identified (nonpersonal) data may be shared with experts and various government agencies responsible for the approval of new drugs, biologics, and devices.
What happens when the study is completed can vary among studies. In the case of the DISCREET Study, participants will stop using the study drug. Clinical trial participants can withdraw from the study at any time without jeopardizing their standard medical care.
Following the end of the study, participants will generally receive study results directly from their study site.