Core Viewpoint - The primary goal of the interim analysis for the recombinant goldenseal vaccine is to reduce the development risk of a Class 1 new drug, with an independent assessment by the DSMB to determine whether to continue clinical trials, rather than using interim analysis data to apply for new drug approval prematurely [1] Group 1 - The company clarified that the clinical trial plan established with the CDE requires that the new drug application can only be submitted after all participants have been enrolled and the observation endpoint has been reached, meaning interim analysis results will not serve as a basis for application [1] - The company has chosen to only unblind the DSMB, while the research team remains blinded, which helps in risk management and avoids premature unblinding that could deplete sample size and affect the final statistical power and integrity of the trial [1]
欧林生物:开展重组金葡菌疫苗期中分析的主要目的是为减少1类新药的研发风险