What is the Role of Clinical Trials in FDA Approval?
Clinical trials are essential for FDA approval as they provide the data needed to assess a treatment's safety and effectiveness. These trials are conducted in three phases:
Phase I: Tests the treatment in a small group of patients to evaluate safety and dosage. Phase II: Expands the study to a larger group to assess efficacy and side effects. Phase III: Involves large-scale testing to confirm effectiveness, monitor side effects, and compare with standard treatments.
Upon successful completion of these phases, the data is compiled and submitted to the FDA for review.
