The reliability and integrity of overall survival data based on follow-up records only and potential solutions to the challenges

Evidence of pre-approval clinical trial supporting the granted conditional approval for novel cancer drugs in China between 2015 and 2022

“… 1 , 2 Overall survival (OS) has been recognized by regulatory agencies as the gold standard globally in clinical decision-making for approval of cancer drugs. 1 , 3 , 4 However, there are several important challenges to the adoption of OS, including being time-consuming, subject to later crossover treatments, and the infeasibility of conducting randomized trials due to the inability to recruit enough patients. 3 , 5 , 6 The U.S. Food and Drug Administration (FDA) first created an accelerated approval pathway primarily in response to the AIDS crisis in 1992.…”