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What is clinical research?

Posted: Tue Sep 05, 2017 2:14 pm
by HSowalla
Clinical research is seeking to find better ways to prevent, diagnose, treat,
and eventually cure NMO. These advances come with improved
understanding of the causes and effects of the disease.
Clinical trials​are designed to determine which medicines or procedures
best benefit patients, and which may not. These studies often involve
expert teams from academic, governmental and pharmaceutical sectors. In
some cases, clinical trials seek to test the efficacy of a new drug for a
disease which has no proven effective therapy. In other trials, one
treatment is compared with another to examine which may be best in
patients of differing disease stage or condition.
There are three phases to clinical trials, these include:
Phase I: ​usually designed to test the “safety” and to learn the best dosing
regimen of a new drug to minimize side effects. Subjects are usually
healthy volunteers, and the study is often relatively short in duration.
Subjects do not usually benefit from a Phase I study.
Phase II:​usually designed to study the drug based on results from Phase I.
Here, the drug, device, or procedure is evaluated in volunteer subjects who
have the disease of interest. Phase II trials further refine safety, minimize
adverse events, and begin to explore if and how the test agent may benefit
the subject. Some volunteer subjects may benefit from a Phase II study. Phase III:​usually compares the test candidate (drug, device, or procedure)
to a commonly used agent that has been proven to be at least somewhat
effective in treating a condition, if one exists. This phase is designed to
understand if the test agent is better than existing approaches, and where
the agent might best fit in managing a particular disease.

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