Promoting Equity without Sacrificing Pragmatism?: Tough Choices for Pragmatic Clinical Trials

Abstract: Embedded pragmatic clinical trials (ePCTs) aim to maintain rigorous research standards while producing valuable evidence to enhance patient care and health outcomes in the clinical setting. This approach aims to enhance the practical relevance of trials by capturing outcomes within the context of everyday patient care, thereby avoiding the need for extensive and costly research infrastructure. However, despite this pragmatic orientation, ePCTs encounter challenges in balancing the imperative of maintaining rigorous research standards with the goal of promoting health equity. In this paper, I argue that efforts to promote pragmatism and equity can sometimes be in tension with each other due to potential trade-offs between the two objectives.

One area of conflict is inclusive participant recruitment, where efforts to recruit a diverse sample may increase costs and compromise trial feasibility. Waivers of consent, while streamlining the recruitment process, may also raise ethical concerns and hinder trust between researchers and minority communities. Site selection for ePCTs often favors well-resourced institutions, potentially excluding historically underserved populations. Enhanced usual care, while addressing disparities in treatment access, can be resource-intensive and may not align with the trial's pragmatic goals. Finally, while electronic health record (EHR) data streamline data collection, efforts to promote equity may require additional data collection for subgroup analysis, which may compromise the trial's pragmatism. Balancing these tensions requires careful consideration and trial designs that prioritize both scientific rigor and social responsibility, ensuring that efforts to address health disparities are integral to the trial's objectives.