Anavex Life Sciences Corp (AVXL)

[Investor2014]

No P4 trials are based on surrogate endpoint likely to infer clinically a meaningful response as the bases for approval. This may be following a P2 or P3 trial.

A P3 trial confirms e.g. a P2b trial's efficacy results and monitors safety in a larger trial.

Study Participants: 300 to 3,000 volunteers who have the disease or condition

Length of Study: 1 to 4 years

Purpose: Efficacy and monitoring of adverse reactions

Researchers design Phase 3 studies to demonstrate whether or not a product offers a treatment benefit to a specific population. Sometimes known as pivotal studies, these studies involve 300 to 3,000 participants.

Phase 3 studies provide most of the safety data. In previous studies, it is possible that less common side effects might have gone undetected. Because these studies are larger and longer in duration, the results are more likely to show long-term or rare side effects

FDA - Step 3: Clinical Research

Study Participants: Several thousand volunteers who have the disease/condition

Purpose: Safety and efficacy

Phase 4 trials are carried out once the drug or device has been approved by FDA during the Post-Market Safety Monitoring