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Updated: Dec 26, 2025

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Alternative clinical trial designs
John A Harvin1, Ben L Zarzaur2, Raminder Nirula3
1Surgery, University of Texas McGovern Medical School, Houston, Texas, USA.
Abstract:
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.
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