What are the Phases of Clinical Trials for Cancer Drugs?
Once an IND application is approved, the drug enters clinical trials, which typically occur in three phases:
Phase I: These trials primarily focus on assessing the safety and dosage of the new drug in a small group of participants, usually 20-80 people. The goal is to identify any side effects and determine the appropriate dosage range. Phase II: In this phase, the drug's efficacy is evaluated in a larger group of participants, usually 100-300 people. Researchers also continue to monitor the drug’s safety. Phase III: These trials involve an even larger group of participants, typically 1,000-3,000 people. The focus is on confirming the drug's effectiveness, monitoring side effects, comparing it to commonly used treatments, and collecting information that will allow the drug to be used safely.
