What is benefit-risk assessment?
Benefit-risk assessment is the process of evaluating whether the therapeutic benefits of a drug or intervention outweigh its potential safety risks. This assessment is critical throughout the product lifecycle, particularly in regulatory submissions, clinical development planning, and payer negotiations.
Why is benefit-risk assessment important?
It guides regulatory approval, formulary placement, and clinical adoption. A well-supported benefit-risk profile strengthens the overall value proposition and informs communication with healthcare providers and patients. It also underpins key decision-making in trial design, post-marketing surveillance, and risk management planning.
