Clinical trials are conducted in phases. The trials at each phase have a different purpose and help scientists answer different questions:
In the pre-clinical phase, researchers determine in a treatment or drug is safe and useful within a lab environment.
In Phase I trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase II trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase III trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase IV trials, post-marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
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If you have taken part in a clinical trial, did you know what phase the drug or treatment was in?
Best,
AnnaHU
