Introduction to Special Issue on Leveraging External Data to Improve Trial Efficiency
Tài liệu tham khảo
Pocock S (1976) The combination of randomized and historical controls in clinical trials. J Chronic Dis 29:175–188
FDA (2019) Adaptive design clinical trials for drugs and biologics guidance for industry. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/adaptive-design-clinical-trials-drugs-and-biologics-guidance-industry
FDA (2020) Interacting with the FDA on complex innovative trial designs for drugs and biological products. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/interacting-fda-complex-innovative-trial-designs-drugs-and-biological-products
Li H, Chen WC, Wang C, Lu N, Song C, Tiwari R, Xu Y, Yue L (2022) Augmenting both arms of a randomized controlled trial using external data: an application of the propensity score integrand approach. Stat Biosci 14:79–89
Quan H, Chen X, Chen X, Luo X (2022) Assessment of conditional and unconditional type I error probabilities for Bayesian hypothesis testing with historical data borrowing. Stat Biosci 14:139–157