Surrogatkriterier

Surrogatkriterier, often translated as surrogate criteria or surrogate endpoints, are measures used in clinical research and drug development that are thought to predict a clinically meaningful benefit but are not a direct measure of clinical benefit themselves. The purpose of using surrogates is to shorten the time and reduce the cost of clinical trials. Instead of waiting for a disease to progress or for a patient's survival to be impacted, researchers can measure a surrogate outcome that is believed to correlate with that longer-term, more significant outcome.

Examples of surrogate criteria include changes in laboratory values, imaging results, or physiological measurements. For instance, in HIV research, a decrease in viral load might be used as a surrogate for improved survival or reduced opportunistic infections. In cancer research, a reduction in tumor size can be a surrogate for increased overall survival. The validity of a surrogate criterion relies on a strong and well-established relationship between the surrogate and the actual clinical outcome. If the surrogate does not accurately predict the benefit, the drug or treatment might be approved based on a surrogate that ultimately does not translate into meaningful patient improvement. Regulatory bodies like the FDA and EMA evaluate the scientific evidence supporting the use of any surrogate criterion before approving treatments based upon it.