Clinical Trials

What are clinical trials?

Clinical trials are studies conducted in order to develop, produce, and evaluate the effectiveness of new treatments and therapies for diseases. All clinical trials involve the participation of human subjects or the use of data collected from medical records. The MetroHealth System manages approximately 150 active clinical trials ranging in focus from vaccination in children to new devices used to save the lives of traumatic injury patients.

What are the phases of a clinical trial?

Most clinical research progresses in an orderly series of steps or phases.

• Phase I trials are the first studies to evaluate how a new drug should be administered (orally, intravenously, by injection), how often, and in what dosage.
• Phase II trials provide preliminary information about how well the new drug works, and generates more information about its safety and benefits. A Phase II trial usually focuses on a particular type of cancer.
• Phase III trials compare a promising new drug, combination of drugs, or procedure with a current standard of treatment.
• Phase IV trials include the continuing evaluation that takes place after FDA approval, when the drug is already on the market and available for general use (post-marketing surveillance).

What is a clinical trial protocol?

A Clinical trial protocol is the action plan or guideline that must be followed during the course of the trial. Guidelines may cover:

• the design of the trial -- what it will trial and how
• who may participate -- criteria for patients who enter the trial
• what medications and medical tests will be used to follow the participants
• what information is being collected

In a single site clinical trial, only one research center will be involved. In a multi-site clinical trial several research centers may be involved and each center uses the same protocol to ensure that information from all centers can be combined and compared.

Where are trials conducted?

Clinical trials are conducted throughout the MetroHealth System, including the main hospital, satellite clinics and long term care center facilities.

Who can participate in a trial?

Each protocol in a trial defines specific characteristics, called eligibility criteria, that participants should have in order to participate in the trial. Characteristics may include type of disease and its stage, as well as the participant's age and general health.

Eligibility criteria help assure that the trial results answer the research question and identify who will benefit in the future from the approach being studied.

How are clinical research trial participants/patients protected?

There are several procedures in place, as part of the protocols, to protect the safety of the people who participate. Two groups that oversee the safety procedures are:

• The organization that sponsors the trial, for example, the National Institute of Health.
• The MetroHealth System’s Institutional Review Board (IRB). The IRB includes physicians, other health care providers, consumers, and community members who do not have any personal interest in the results of the trial. As neutral reviewers, they try to ensure that the trial is conducted fairly and that participants are not likely to be harmed. All clinical trials require approval from the IRB before the trial may begin. The IRB reviews clinical trials on no less than an annual basis and conducts thorough, random audits to insure that patient’s rights are being protected.

For information on how to participate in a clinical trial at MetroHealth Medical Center, please talk with your physician or contact MetroHealth Medical Center’s Assistant Director for Clinical Research, Kelly Robertson, at krobertson@metrohealth.org.