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WHAT IS A CLINICAL TRIAL?

A clinical trial is the testing of an experimental medication or device by human volunteers.  All procedures are closely monitored and are done under highly controlled conditions.  Study subjects receive more medical supervision and testing than an average patient would for their condition. Study subjects must come to the MNI for treatment and/or follow-up visits at regular intervals, and will undergo several tests at different visits.

The Clinical Research Unit participates in all phases of clinical trials (I-IV) conducted on patients with a neurological disease.

The first time the study drug is tried in humans to evaluate the safety and side effects of different dosages. Phase I trials ahve been previously conducted with healthy volunteers. These trials usually last several months and recruits 20 – 80 subjects.

More subjects (100-300) are studied for a longer duration (more than 1 year) to establish efficacy of 2 or 3 dosages and to evaluate safety.

These trials recruit 1,000 or more subjects to confirm efficacy of one or two doses of study drug and lasts for 1-2 years. Sometimes the study drug is compared to a standard of therapy.

These are post-marketing studies usually comparing an approved drug to another.

What can I do to help?

Consider volunteering either as a healthy volunteer or as a participant who has a particular disease or condition. Contact the CRU at info-CRU.neuro@mcgill.ca

For more information on clinical trials: www.clinicaltrials.gov