Surrogate End Points and Their Validation in Oncology Clinical Trials

open access - Editorial

 ....Continuous efforts to improve the validation of surrogate end points are important in several ways. First, the FDA’s accelerated approval program relies on surrogate end points. This program was initiated in 1992 to allow for the earlier approval of drugs that treat serious conditions and that fill a previously unmet medical need on the basis of a surrogate end point. Second, in this era of personalized medicine and rapid development of oncology drugs, many drugs are in the pipeline, waiting for testing in phase III clinical trials. Third, it is difficult, if not impossible, to conduct a phase III trial with OS as the primary end point for a rare disease. Fourth, the current research-funding situation prohibits large trials. Surrogate end points usually allow for smaller trials and shorter completion times and, once validated, could help resolve these issues.