Work

Alternative clinical trial designs

Year: 2020

Type: article

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.

Source: Trauma Surgery & Acute Care Open

DOI: 10.1136/tsaco-2019-000420

Authors: John A Harvin, Ben L Zarzaur, Raminder Nirula, Benjamin T King, Ajai K Malhotra

Institutions: University of Wisconsin–Madison, University of Utah, The University of Texas at Austin, University of Vermont Medical Center

Language: English

Topic: Statistical Methods in Clinical Trials

Subfield: Statistics and Probability

Field: Mathematics

Domain: Physical Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $2,100