Clinical Trials Lecture 4
Clinical Trials Lecture 4
Clinical Trials Lecture 4
• Chronic toxicity
• Carcinogenicity
• Clinical trials testing new treatments are divided into different stages,
called phases.
For most medicines, the first human exposure takes place in healthy
volunteers and participants are very closely monitored with clinical
supervision.
Phase I clinical trials are done to test a new treatment for the first time in a
small group of people (e.g. 20-80) to evaluate safety (e.g. to determine a
safe dosage range and identify side effects).
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Phase II Clinical Trial
• Phase III studies are also used to monitor adverse effects and
to collect information that will allow the intervention to be used
safely.
Phase IV Clinical Trial (Post-
marketing surveillance (PMS):
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Clinical trials will identify most common adverse reactions but often have
important limitations, including:
• The numbers of patients studied is generally not enough to identify rare but serious
ADRs.
• The artificial conditions – patients are likely to be more closely monitored than in
real life.