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What is a clinical trial?
A clinical trial tests a new drug in humans after extensive research has taken place in preclinical studies. Clinical studies are carefully designed to protect patient safety and evaluate the effects of a potential medication or device in a group of healthy volunteers or patients suffering from a specific disease. The U.S. Food and Drug Administration (FDA) reviews all trial designs. Clinical studies are conducted in progressive phases and are required steps in making new drugs available for people in need.

Who can participate in a clinical trial?
People with the health condition being studied as well as healthy people can volunteer to be in clinical trials, depending on the phase of the study. Every clinical trial has inclusion and exclusion criteria. The physician conducting the study will review each volunteer’s medical history and study requirements to determine who can participate. The study physician will also explain known risks, discomforts, study protocol and potential benefits to volunteers participating in the study.

What is meant by a blinded study?
In a double-blinded study, neither the physicians nor the volunteers know who receives the placebo (a non-active substance that is identical in appearance to the drug being studied) and who receives the investigational drug. In a single-blinded study, only the physician knows. A placebo is used as a comparison to help evaluate what normally happens to a patient with a specific condition.

What are the responsibilities of someone participating in a clinical trial?
It is important that people participating in a clinical trial follow the established protocol to ensure their safety and to provide the needed information so that the drug can be properly evaluated by regulatory authorities. A protocol is a description of the study and rules for its conduct. It includes an explanation of the patient’s responsibilities, including doctor visits, dosing schedules and rules regarding use of additional medications. In some trials, participants may also be asked to keep a journal to record their experiences with the investigational drug.

How can I get more information about Isis’ clinical trials?
If you need information about a trial or want to enroll in a trial, please visit www.clinicaltrials.gov.  This government-sponsored website lists most ongoing trials including those for which enrollment is currently taking place.  Information is searchable by company, by drug candidate, by specific indication and by disease area.  For each trial, the investigator is named and enrollment information is provided if appropriate.

Information can also be obtained by leaving a message on the following Isis toll-free number: 1-800-679-ISIS (4747), or by sending us an e-mail at trialinfo@isisph.com.  These latter two channels are most appropriate if you'd like to speak with one of our clinical operations professionals about qualifying as a site or about supplying external services and support for clinical trials.