Clinical Trial Terms

Important Terms to Know

If you are considering volunteering for a clinical trial, some of the terminology that is used may be unfamiliar to you. The following are some of the more common terms with which you may want to familiarize yourself with. For more general information about clinical trials, please visit here.

Efficacy

A product's ability to product beneficial effects on the duration or course of the disease.

Endpoints

These are the measures that will determine whether the treatment is effective, such as lowering cholesterol level or blood pressure, increasing range of motion, reducing tumor size, etc.

Inclusion/Exclusion Criteria

This simply defines the profile of the person eligible to participate in the study considering such factors as whether the person has the condition, age, other medical conditions, current medications, tobacco, alcohol or drug use, etc.

Informed Consent

Prior to beginning a clinical trial, a participant is provided with a detailed description of the study that outlines risks, benefits, procedures and responsibilities, to ensure the volunteer is sufficiently advised.

Investigator

The person in charge of your trial. This may be your physician or another health care professional who is overseeing the research.

Investigational Medication

A drug used in clinical trials before the marketing application has been approved by the FDA.

Institutional Review Board (IRB)

The IRB is a panel of independent experts who review the clinical trial to ensure it has been designed ethically, meets community standards, and that every attempt has been made to ensure the safety and welfare of the participants, within the context of a medical experiment. The IRB reviews the trial protocol, Informed Consent document, recruitment advertising and other aspects of the trial. No clinical trial may begin without the approval of an IRB.

Patient Volunteer

Participation in a clinical trial is always voluntary and you may choose to quit a trial at any time. With the exception of Phase I trials that usually involve healthy volunteers, clinical trial participants are generally patients with the disease or condition being studied. But because the clinical trial is an experiment that may not provide a proven benefit to the individual, it is important to understand the difference between research and treatment. Historically, clinical trial volunteers have been referred to as “research subjects” but there is a movement away from use of this term.

Protocol

This refers to how the trial will be administered (pill/liquid/IV/injection), how often a treatment will be given, and in what dosage. This also dictates what tests will be administered and what data will be gathered (blood pressure, blood tests, imaging, etc.).

Research Site

A research site simply refers to the physical location where research is being conducted. This may be a hospital, group practice, clinic or an independent research facility.

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