Original Publication Date: 22 January, 2014
Publication / Source: Lung Cancer Management
Authors: Sumithra J Mandrekar
Overall survival (OS), defined as the time from randomization or registration to death from any cause, is the gold standard end point in clinical trials as it is a measure of direct clinical benefit to a patient. OS as an end point is unambiguous and can unequivocally assess the benefit of a new treatment relative to the current standard of care. While improving OS remains the ultimate goal of new cancer therapy, an intermediate end point, such as progression-free survival (PFS), a composite end point defined as time from randomization to disease progression or death, is commonly used to evaluate the treatment effect of new oncologic products studied in randomized controlled trials (RCTs) .