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Phase IV Trials

Phase IV clinical trials are conducted to identify and evaluate the long-term effects of new drugs and treatments over a lengthy period for a greater number of patients. Phase IV research takes place after the FDA approves the marketing of a new drug. Through Phase IV studies, new drugs can be tested continuously to uncover more information about efficacy, safety and side effects after being approved for marketing.

Phase IV Research: Suitable Patients

Phase IV clinical trials involve patients who have been taking the new drug or treatment under supervision for a considerable amount of time. Since patients typically receive medical care and prescriptions from physicians’ offices, these locations are where most Phase IV research is conducted.

Phase IV Research: The Purpose

Since Phase IV clinical trials are more intensive and specified, they often test the drugs’ effect on specific demographics. This can include pregnant women or people who are currently taking other medication to see if there is a reaction between the two drugs. Phase IV research is conducted over such an extensive period and on a massive population, long-term and unique effects can be precisely identified and measured. In addition, Phase IV clinical trials can be conducted to find new markets for competitive analysis on the drug or treatment.

Common Questions:

What is a Clinical Research Trial?
Why Participate in a Clinical Research Trial?
Is there a difference between Clinical Trials and Treatment?
How are New Drugs Tested?

Learn More About Clinical Trials:

What Types of Clinical Trials are Available?
Phase I Clinical Trials
Phase II Clinical Trials
Phase III Clinical Trials
Glossary of Clinical Trial Terminology
Alabama Health Resources
Brief History of Clinical Trials
Find Clinical Trials

Know Your Rights as a Participant:

Your Patient Rights
Patient Privacy Rules
Informed Consent Agreement
NIH Patient Bill of Rights
Legal, Ethical, and Safety Issues