Patient-centeredness in the design of clinical trials

Abstract

Evidence from clinical trials should contribute to informed decision making and a learning health care system. People frequently, however, find participating in clinical trials meaningless or disempowering. Moreover, people often do not incorporate trial results directly into their decision making. The lack of patient centeredness in clinical trials may be partially addressed through trial design. For example, Bayesian adaptive trials designed to adjust in a prespecified manner to changes in clinical practice could motivate people and their health care providers to view clinical trials as more applicable to real-world clinical decisions. The way in which clinical trials are designed can transform the evidence generation process to be more patient centered, providing people with an incentive to participate or continue participating in clinical trials. To achieve the transformation to patient-centeredness in clinical trial decisions, however, there is a need for transparent and reliable methods and education of trial investigators and site personnel.

Keywords: Bayesian; adaptive; patient-centered; pragmatic; trial design.

Figure 1

Means by which trials designs can promote recruitment and retention in clinical trials by improving the patient experience.

Figure 2

A diagram showing points in the clinical trial process (illustrated as dashed lines) where trial design and statistical approaches can impact patient recruitment and retention.