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Clinical Research Trials

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.

• Volunteers receive expert medical care under the close supervision of the research team which consists of physicians and research professionals.
• Volunteer participation contributes to the knowledge of medical science and potentially helps you and others live longer, healthier lives.
• Volunteers may receive promising, experimental therapy which is not available to the general public. The experimental therapy may or may not be beneficial to the volunteer.

Risks of Participation:

• The experimental therapy may not be effective or volunteers may experience side effects.
• Participation in the clinical research trial may require more time, treatments, and physician and hospital visits than non-participation.

Types of volunteers:

• Healthy adults without a specific medical diagnosis. This group provides important information to the research team by helping to compare how healthy people differ medically from those with a specific diagnosis. Referred to as a control group, these volunteers do not receive the experimental therapy being studied.
• Adults with a specific medical disease or diagnosis. These volunteers are looking to expand their health care options. Referred to as a treatment group, these volunteers may receive an experimental therapy.

Inclusion and Exclusion Criteria:

• Guidelines that allow for participation in a clinical research trial are called "inclusion criteria." Each clinical research trial is unique with very specific criteria about who can participate.
• Guidelines that do not allow participation in clinical research trial are called "exclusion criteria."
• Being specific and selective about who can participate helps to produce reliable results.
• Inclusion in a clinical research trial should be the result of an in-depth conversation amongst the volunteer, the primary physician, and the research team.

General Information about Participation:

• Participation in a clinical research trial is completely voluntary. Research teams will be very grateful for your willingness to contribute your time, with the hope that you will benefit from this experience.
• Prior to participation, volunteers will be asked to sign an informed consent document and a HIPPA document. Volunteers will be given detailed instructions that explain the clinical research trial. These instructions are referred to as a "protocol." A protocol outlines how the clinical research trial will be conducted, including tests and treatments involved.
• Participation can be stopped at any time by the volunteer without compromising or affecting future medical care. Early discontinuation from the clinical research trial should be avoided as the success of the trial depends on the research team's ability to collect complete data. Volunteers that need to withdraw should notify the research team and provide the reasons for leaving the trial.
• Participation is not meant to replace the care received from your primary physician, but may expand health care options.
• Volunteers will be carefully assessed before, during and after the clinical research trial.
• Volunteers are asked to contact the research team if they are hospitalized, at anytime, while participating in a clinical research trial, especially if not hospitalized at Northwestern Memorial Hospital, so that care can continue to be monitored.

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:

• While involved in the clinical research trial you will continue to receive careful medical attention from your primary physician.
• The members of the research team are intended to serve as an additional support for your current treatment and do not take the place of your primary physician.
• The research team will be in constant communication with your primary physician.

IRB:
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.

Informed Consent:

• The FDA requires that volunteers be given written, detailed information about the clinical research trial before they agree to participate. This information is referred to as the informed consent document.
• Information in the informed consent document will be explained to the volunteer by the research team.
• Volunteers will be encouraged to read the informed consent document and ask the research team to explain information that is not clear.
• Volunteers are free to decide whether or not to take part in the clinical research trial. If the volunteer decides to take part in the trial, they will sign the informed consent document and receive a copy. This copy contains important information about the clinical research trial that the volunteer may want to refer to during the trial. The volunteer may decide not to take part in the clinical research trial. This is the right of the volunteer and their future medical care will not be affected or compromised in any way.

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.

• What is the purpose of the clinical research trial?
• What phase is the clinical research trial?
• Has there been previous research done on this experimental therapy? If yes, what are the results?
• How does the experimental therapy compare with the standard treatment options?
• How long will the clinical research trial last?
• What tests and treatments are involved?
• Who will pay for the tests and treatments?
• What are the benefits and risks involved in participating in this clinical research trial?
• Will hospitalization be required? If yes, how long and how often?
• What type of long-term follow up care is part of this clinical research trial?
• Who do I contact if I have questions during the clinical research trial?

In Conclusion:
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.