PT  - JOURNAL ARTICLE
AU  - John A Harvin
AU  - Ben L Zarzaur
AU  - Raminder Nirula
AU  - Benjamin T King
AU  - Ajai K Malhotra
ED  - ,
TI  - Alternative clinical trial designs
AID  - 10.1136/tsaco-2019-000420
DP  - 2020 Feb 01
TA  - Trauma Surgery & Acute Care Open
PG  - e000420
VI  - 5
IP  - 1
4099  - http://tsaco.bmj.com/content/5/1/e000420.short
4100  - http://tsaco.bmj.com/content/5/1/e000420.full
SO  - Trauma Surg Acute Care Open2020 Feb 01; 5
AB  - 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.