Evaluation of Benefit-Risk

Drug authorization, prescription and utilization are all based on benefitrisk assessment. This is made difficult by the apparent lack of objective means to measure the balance and by limitations regarding each of the two items.Benefit is sometimes measured by surrogate indicators of a real clinical advantage. It is assumed to be applicable to individuals even though it is measured in populations, and is represented in different ways that may convey different messages to physicians and patients. Risks are also hard to predict on an individual level. They may also be overlooked or revealed later than benefit, thus biasing the balance for a long time. Their causal relationship with the treatment is often not fully established. The benefit-risk balance itself has no generally recognized measure. This is why benefits and risks are hard to compare; either one or both may occur in single patients, and a risk-benefit profile that is acceptable in severe diseases may not be acceptable in diseases with a favourable prognosis.