The safety profile of a cancer treatment is established through multiple stages:
Preclinical Studies: Initial safety assessments are conducted in laboratory and animal studies. Phase 1 Clinical Trials: Small groups of patients are tested to evaluate safety, dosage, and side effects. Phase 2 and 3 Clinical Trials: Larger groups of patients are involved to further assess safety and efficacy. Post-Marketing Surveillance: After approval, ongoing monitoring is done to detect any long-term or rare adverse effects.