A Clinical Trials Primer
Basically a clinical trial is a scientific research involving people, that studies the effects of a new medication, therapy or device to determine if it is safe and effective.
In the United States, clinical trials are monitored by the Food and Drug Administration.
The Phases of a Clinical Trial:
Phase I evaluates dosage parameters.
Phase II continues to evaluate safety and begins to study efficacy.
Phase III compares the new drug with standards of care or if there are none, a placebo.
Phase IV is used if the drug normally used as a standard is to be used for another condition or if the formulation is changed. This phase may also be used for extended studies on drug side effects.
Raquel Billiones has a PhD in Biology and has over 15 years experience as a researcher, scientific English teacher, and medical writer. Since 2006, she has been a freelance WAHM specializing in medical writing and scientific documentation. 
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