The Vital Role of the Clinical Trials Nurse: Enhancing Success and Overcoming Challenges Through Collaboration

Vollständiger Abstract

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Background and Purpose: Barriers to patient recruitment, retention, and diversity are persistent challenges in clinical trials (CTs). With little evidence to advise best practices, clinical trials nurses (CTNs) remain an overlooked, patient-oriented resource. Applying a theoretical lens when investigating a complex problem ensures scientifically grounded inquiry and robust interpretation. The aims of this work were to evaluate the utility of D’Amour’s structuration model of collaboration (SMC) for clarifying CTN roles and contributions; analyze how barriers to CTN collaboration affect research patient burden, safety, and participation; and examine how collaborative structures within the industry influence CTN involvement in CT design and conduct. Methods: SMC was selected as the theoretical mechanism because it functions reliably across organizational boundaries. A focused, theory-guided literature review was performed to map relevant evidence. Results: Findings indicated that CTNs represent a small, complex, and understudied specialty. Due to this niche status, CTNs have had limited representation within networks that facilitate disciplinary oversight and proactive patient advocacy. SMC articulates this relegation to downstream study operations. Although shared goals exist, a lack of CTN expertise in early study development perpetuates inefficiencies. This latent degree of collaboration is rooted in weak internalization and hindered by absent formalization and governance structures. Implications: CTNs are frequently cited as experts who enhance CT safety and overall success; however, this has not been thoroughly quantified. Therefore, in addition to CTN inclusion during CT design and protocol development, their consultative scope and impact must also be systematically measured and disseminated. Cultivating this knowledge could elevate CTN subspecialties into advanced practice status.