Envisioning clinical trials as complex interventions

Abstract

Clinical trials are critical components of modern health care and infrastructure. Trials benefit society through scientific advancement and individual patients through trial participation. In fact, billions of dollars are spent annually in support of these benefits. Despite the massive investments, clinical trials often fail to accomplish their primary aims and trial enrollment rates remain low. Prior efforts to improve trial conduct and enrollment have had limited success, perhaps due to oversimplification of the complex, multilevel nature of trials. For these reasons, the authors propose applying implementation science to the clinical trials context. In this commentary, the authors posit clinical trials as complex, multilevel evidence-based interventions with significant societal and individual benefits yet with persistent gaps in implementation. An application of implementation science concepts to the clinical trials context as means to build common vocabulary and establish a platform for applying implementation science and practice to improve clinical trial conduct is introduced. Applying implementation science to the clinical trials context can augment improvement efforts and build capacity for better and more efficient evidence-based care for all patients and trial stakeholders throughout the clinical trials enterprise.

Keywords: clinical trials; complex interventions; health services research; implementation science; quality improvement.

FIGURE 1

Conceptual model of a smoking cessation intervention. (A) Description of core components and adaptable periphery. (B) Examples of applied core components and adaptable periphery in a hypothetical smoking cessation intervention.

FIGURE 2

Conceptual model of a clinical trial as a complex intervention. (A) Description of core components and adaptable periphery. (B) Examples of applied core components and adaptable periphery in a hypothetical clinical trial.