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 CRU participates in all phases of clinical trials I – IV, which are conducted on patients with a neurological disease.

Trial Phases:

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

Phase II – 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.

Phase III – 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 therapy.

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

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