Phase III of a clinical trial usually involves up to 3,000 participants who have the condition that the new medication is meant to treat. Trials in this phase can last for several years.
The purpose of phase III is to evaluate how the new medication works in comparison to existing medications for the same condition. To move forward with the trial, investigators need to demonstrate that the medication is at least as safe and effective as existing treatment options.
To do this, investigators use a process called randomization. This involves randomly choosing some participants to receive the new medication and others to receive an existing medication.
Phase III trials are usually double-blind, which means that neither the participant nor the investigator knows which medication the participant is taking. This helps to eliminate bias when interpreting results.
The FDA usually requires a phase III clinical trial before approving a new medication. Due to the larger number of participants and longer duration or phase III, rare and long-term side effects are more likely to show up during this phase.
If investigators demonstrate that the medication is at least as safe and effective as others already on the market, the FDA will usually approve the medication.
Companies that sell Phase III Clinical Research Organizations (Phase III CRO)
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