NutzenRisikoAbwägungsprozesses

Nutzen-Risiko-Abwägung, or benefit-risk assessment, is a systematic framework for comparing desirable and undesired effects of a medical intervention to inform decision making in health care and policy. It aims to balance potential therapeutic benefits against possible harms in a transparent, evidence-based manner.

Used in drug approvals, vaccines, medical devices, treatment guidelines, payer decisions, and public health programs, it integrates data on efficacy, safety, quality of life, and resource use. The assessment draws from clinical trial results, observational studies, pharmacovigilance data, and real-world evidence to build a comprehensive picture of net value.

Methods range from qualitative judgments to quantitative analyses, including explicit weighting and decision-analytic approaches such as multicriteria decision analysis (MCDA). Results depend on the context and the values and preferences of stakeholders, including patients, clinicians, regulators, and payers.

Typical steps involve defining the decision question and context; identifying benefits and risks; collecting and synthesizing evidence; assessing magnitude, frequency, and uncertainty; comparing net value; documenting rationale; and planning monitoring and follow-up after implementation.

Challenges include incomplete data, bias, and methodological uncertainty; variation in risk tolerance among patients and societies; heterogeneity across populations; ethical considerations; and limitations of post-market surveillance. The approach is dynamic and may be revisited as new information emerges.

The concept is closely tied to risk assessment, pharmacovigilance, and risk-management frameworks, with formal guidelines from health authorities to support transparent, consistent decision making.