Dow Division of Health Services Research, Department of Urology, University of Michigan, Ann Arbor, Michigan, USA.
Department of Learning Health Sciences, University of Michigan, Ann Arbor, Michigan, USA.
Cancer. 2022 Sep 1;128(17):3145-3151. doi: 10.1002/cncr.34357. Epub 2022 Jun 29.
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.
临床试验是现代医疗保健和基础设施的重要组成部分。通过科学进步使整个社会受益，通过试验参与使个体患者受益。事实上，每年都有数十亿美元用于支持这些效益。尽管投入巨大，但临床试验往往未能实现其主要目标，且试验入组率仍然很低。先前为改善试验实施和入组所做的努力收效有限，这可能是由于对试验的复杂多层次性质的过度简化。出于这些原因，作者建议将实施科学应用于临床试验领域。在这篇评论中，作者将临床试验视为具有复杂多层次的循证干预措施，具有重大的社会效益和个体效益，但在实施方面仍存在差距。将实施科学概念应用于临床试验领域，作为构建共同词汇和建立应用实施科学和实践以改善临床试验实施的平台的手段被提出。将实施科学应用于临床试验领域可以增强改进效果，并为整个临床试验企业中的所有患者和试验利益相关者提供更好、更高效的循证护理的能力。
