Participating in a Clinical Research Trial
It is estimated that each year, millions of people volunteer to participate in clinical research trials (sometimes called studies or protocols). A clinical research trial is a carefully designed study to answer an important medical question. Clinical research trials are conducted to collect information on people like you that volunteer to receive experimental therapies over a period of time under the close supervision of physicians and research professionals. Clinical research trials are conducted in a careful, step-by-step process, and can determine if one treatment is better than another. Experimental therapies tested during clinical research trials can take the form of a new drug, treatment or device.
A brief description of the clinical research trial process follows and is designed to help potential volunteers make an educated decision about participating in a clinical research trial at Northwestern Memorial Hospital's Bluhm Cardiovascular Institute. You may have questions that this section does not answer. You are encouraged you to discuss any questions that you have with your primary physician and the research team.
Benefits of Participation
People volunteer to participate in clinical research trials for many reasons - to advance science, find new treatments or just to receive additional medical attention. Whatever your reason, it is important that you make an informed decision about volunteering.
Risks of Participation
Types of Volunteers
Inclusion and Exclusion Criteria
General Information About Participation
Privacy and Safety for the Volunteer
The privacy and safety of the volunteer are the most important factors when conducting clinical research trials. The privacy of the volunteer will be protected at all times, even after the trial is completed. Data that is provided to the Food and Drug Administration (FDA) or published in medical journals will not identify you by name.
There are three main safeguards in place to help protect the volunteer: your primary physician and the research team, the Institutional Review Board (IRB) and the informed consent document.
Your Primary Physician and the Research Team
An IRB is an FDA-mandated committee consisting of health care professionals, scientists, and non-medical people from the local community who review all clinical research trials to ensure that volunteer safety is protected, personal rights are respected, and that volunteers are fully informed about the clinical research trial.
Phases of a Clinical Research Trial
Clinical research trials are conducted in four phases. Each phase is a separate clinical research trial. One volunteer rarely participates in more than one phase of the same trial. At each phase, clinical research trials have a different purpose and help the research team answer different questions.
Phase I trials:
a phase one trial is the first use of a new drug in humans. In a phase one study, the new experimental therapy is tested in a small, healthy group of people for safety and side effects.
Phase II trials:
a phase two trial is set up to look at the safety and effectiveness of a new experimental therapy. In a phase two trial, the new experimental therapy is tested in a group of people who have the disease or condition for which the experimental therapy was developed.
Phase III trials:
a phase three trial is set up to look at the new experimental therapy versus standard therapy/care. A phase three trial will enroll a large number of people who have the disease or condition for which the experimental therapy was developed.
Phase IV trials:
a phase four trial may be done to study the safety and effectiveness of the therapy. At this point the therapy is already approved by the FDA and is available for general use.
Questions to Ask the Research Team
Prior to agreeing to participate, volunteers should know as much as possible about the clinical research trial and feel comfortable asking questions about the protocol, including the risks and benefits. The research team wants you to be an informed volunteer that is knowledgeable about the clinical research trail. Throughout the clinical research trail, if you have questions or need more information, please ask the research team. Answers to some of these questions may be found in the informed consent document. The following questions may be helpful for the volunteer.
Clinical research trials search for new and better ways to understand and treat disease. Participating in a clinical research trial is an informative learning experience for the volunteer. Please consider volunteering in a clinical research trial as your participation will contribute to important advancements of medical knowledge.
Clinical Trials Unit