Thomas Jemielita

Jan 19, 2025 | tandfonline.com | Thomas Jemielita |Cong Chen

ABSTRACTRandomized clinical trials (RCTs) can benefit from using Real-World Data (RWD) as a supplementary data source to enhance their analysis. An Augmented RCT combines randomized treatment and control groups with synthetic controls derived from RWD. This way, the trial can achieve less prospective enrollment, higher statistical power, and lower costs. However, to ensure scientific validity, the synthetic controls must satisfy the same eligibility criteria as the trial participants.

Apr 25, 2023 | onlinelibrary.wiley.com | Thomas Jemielita

Abstract The augmented randomized controlled trial (RCT) with hybrid control arm includes a randomized treatment group (RT), a smaller randomized control group (RC), and a large synthetic control (SC) group from real-world data. This kind of trial is useful when there is logistics and ethics hurdle to conduct a fully powered RCT with equal allocation, or when it is necessary to increase the power of the RCT by incorporating real-world data.