Merson Laura, Witt Karolina, Hussaini Arishay, Siddiqui Ayesha, Harriss Eli, Webb Steve, Njuguna Patricia, K Shah Divya, Chan An-Wen, Terry Robert, Siegfried Nandi, Stolow Jeni, Denis Emmanuelle, Hashmi Madiha
Pandemic Sciences Institute, ISARIC, University of Oxford, Oxford, OX3 7LF, UK.
Critical Care Medicine, Ziauddin University, Karachi, Sindh, 75000, Pakistan.
Wellcome Open Res. 2025 Mar 6;9:729. doi: 10.12688/wellcomeopenres.23135.2. eCollection 2024.
Synthesise the published literature and national regulations on infrastructure, capabilities and capacities required to manage and quality assure clinical research.
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.
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.
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.
综合已发表的文献以及关于管理和确保临床研究质量所需的基础设施、能力和容量的国家法规。
世界卫生大会（WHA）第75.8号决议（2022年）呼吁“加强全球协调和高质量临床试验架构”。为此，必须理解并推进设计和开展高质量临床试验所需的基础设施、能力和容量。本快速范围审查旨在确定法规、国家立法和已发表文献中关于有效管理临床试验的要求和建议的广度。研究结果将归纳为主题。这将为评估和发展进行观察性研究及干预性临床试验的单位提供一个框架。
推荐管理和确保临床试验质量所需的基础设施、能力和/或容量的同行评审文献、灰色文献和国家立法。由设计、管理、资助、赞助、监管或监督临床试验的人员撰写的出版物。
将通过Ovid平台上的Medline、Embase、PsycINFO和Global Health；SCOPUS；科学引文索引核心合集；以及使用特定字段代码的世界卫生组织全球医学索引来识别同行评审文献和灰色文献，以提高搜索词的特异性。不设日期、语言或地理限制。由两名盲态评审员筛选去重后的标题和摘要，如有分歧则由第三名评审员解决。灰色文献可通过同行评审文献识别，并辅以对谷歌和DynaMed的结构化搜索。国家法规将从网上和现有摘要中获取。全文文献和法规将由一名评审员进行筛选，第二名评审员进行适当的核实。数据将在NVivo软件中提取并编码以寻找模式。所有项目和代码将使用主题框架分析进行总结，并识别每个主题中的核心结构。
