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What are the 4 Phases of Clinical Trials?

Phase I

Between 50 and 100 healthy individuals usually participate in this phase. Phase 1 research examines the drug’s safety, identifies its side effects, and considers the best way to administer it.

Phase II

Individuals with the ailment for which the medication, equipment, product, or treatment has been developed typically take part in this stage, which typically involves 100 to 300 patients. The goal of research is to evaluate the medicine’s short-term safety and efficacy, identify the dosage that produces the fewest side effects, and compare the drug to a placebo on a small scale.

Phase III

A wider pool of volunteers is required in this phase. Typically, between a few hundred and a few thousand patients take part, allowing researchers to validate the treatment’s efficacy and safety and contrast the new drug.

Phase IV

After the medicine has been approved, researchers will examine its efficiency in a wide range of patients, keep track of its safety in a sizable population, and enable the creation of new applications for the substance. These trials, which frequently involve thousands of patients, can guide future investigation and advancement.

Clinical Trial Research Summary

The more advanced stages of the study the more mature or developed the investigational drug or device exists. So you should feel safe when you are engaging with these studies in the later phases, namely 3 and 4.

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Albert Cheng

Dr. Albert Cheng Medical Science and Medical Affairs 4 years of global clinical experience and 2 year clinical trials management, with all-round 1.5-year U.S. clinic and hospital experience. Education: Our Lady of Fatima University Metro Manila, Philippines Doctor of Medicine (M.D.) 2008-2014 3 years clinical, 1.5 year in U.S., and 3 years theoretical medicine. University of California, Irvine Irvine, California Bachelor of Engineering in Biomedical Engineering (BEng)2004-2007