Infrastructure, capabilities, and capacities required for clinical trials design and delivery: A rapid scoping review of recommendations and regulations.

Abstract

Objective: Synthesise the published literature and national regulations on infrastructure, capabilities and capacities required to manage and quality assure clinical research.

Introduction: The World Health Assembly (WHA) resolution 75.8 (2022) called "for a strengthened global architecture for coordinated and high-quality clinical trials". For this remit, infrastructure, capabilities, and capacities needed to design and deliver high-quality clinical trials must be understood and advanced. This rapid scoping review aims to identify the breadth of requirements and recommendations for effective management of clinical trials in regulations, national legislation and the published literature. The findings will be summarised into themes. It will inform a framework for the assessment and development of units undertaking observational studies and interventional clinical trials.

Inclusion criteria: Peer-reviewed literature, grey literature, and national legislation that recommends infrastructure, capabilities, and/or capacities needed to manage and quality assure clinical trials. Publications authored by those who design, manage, fund, sponsor, regulate or oversee clinical trials.

Methods: Peer-reviewed and grey literature will be identified through Medline, Embase, PsycINFO, and Global Health via Ovid; SCOPUS; the Web of Science Core Collection; and the WHO Global Index Medicus using specific field codes to increase the specificity of the search strings. No date, language, or geographic limits will be applied. Deduplicated titles and abstracts will be screened by two blinded reviewers with discrepancies resolved by a third reviewer. Grey literature may be identified through the peer reviewed literature, supplemented with structured searches of Google and DynaMed. National regulations will be sourced online and from available summaries. Full text literature and regulations will be screened by a single reviewer, with proportionate verification by a second reviewer. Data will be extracted and coded for patterns in NVivo software. All items and codes will be summarised using a thematic framework analysis and identify core constructs within each theme.