Global initiatives to improve clinical investigation efficiency: a scoping review of implemented system-level reforms.

BACKGROUND: The process for initiating a clinical trial is lengthy, expensive, and often involves a large amount of redundant work. There has been a large number of programs, reforms and reviews carried out by regulators, academics, government groups and other stakeholders globally to identify the barriers to and make recommendations for enhancing initiation of clinical trials and improving their efficiency with comparatively little success. This study aimed to identify key initiatives implemented to date and determine the critical factors contributing to their success. METHODS: This study utilises a scoping review of a wide range of data sources to ascertain what are the key programs undertaken to date to improve clinical trial initiation and to understand the critical success factors of these. Following screening and selection, 27 data sources from 19 relevant programs were included in this review. Sources were included if they were an initiative that had been implemented, in any jurisdiction, to improve the efficiency of the trial initiation process, for medical devices or pharmaceuticals. Included sources were analysed to identify common characteristics, approaches, and determinants of successful implementation. RESULTS: Most initiatives aimed at improving clinical trial efficiency were identified in the United States, despite the issue being global in scope. The majority of programs are regulatory bodies or research groups or a combination of both. Key determinants of success included the stakeholders involved, as well as the resources and approach to increasing efficiency. Programs reporting success attributed this to enthusiastic stakeholders from diverse backgrounds and who had the authority to implement the planned changes. Effective resource utilisation included pooling expertise and infrastructure from large networks, adopting new technologies, and employing dedicated staff. A key aspect of the approach was to create a standardised and centralised system. CONCLUSION: Efforts to improve clinical trial initiation have predominantly been concentrated in the United States and are commonly driven by collaborative regulatory and research-focused initiatives. Successful programs are characterised by multidisciplinary stakeholder engagement, operational authority, shared resources, technological integration, and centralised standardised systems. These findings may inform the development of future strategies to improve the efficiency of clinical trial initiation globally.