TY - JOUR T1 - Alternative clinical trial designs JF - Trauma Surgery & Acute Care Open JO - Trauma Surg Acute Care Open DO - 10.1136/tsaco-2019-000420 VL - 5 IS - 1 SP - e000420 AU - John A Harvin AU - Ben L Zarzaur AU - Raminder Nirula AU - Benjamin T King AU - Ajai K Malhotra A2 - , Y1 - 2020/02/01 UR - http://tsaco.bmj.com/content/5/1/e000420.abstract N2 - High-quality clinical trials are needed to advance the care of injured patients. Traditional randomized clinical trials in trauma have challenges in generating new knowledge due to many issues, including logistical difficulties performing individual randomization, unclear pretrial estimates of treatment effect leading to often unpowered studies, and difficulty assessing the generalizability of an intervention given the heterogeneity of both patients and trauma centers. In this review, we discuss alternative clinical trial designs that can address some of these difficulties. These include pragmatic trials, cluster randomization, cluster randomized stepped wedge designs, factorial trials, and adaptive designs. Additionally, we discuss how Bayesian methods of inference may provide more knowledge to trauma and acute care surgeons compared with traditional, frequentist methods. ER -