PO.BCS01.12 · 生物信息与计算
采用可配置、技术驱动的监督模式，规范全球肿瘤学试验中的患者安全与研究中心合规性
Standardizing global patient safety and site compliance in oncology trials using a configurable, technology-driven oversight model
作者与单位 Authors & Affiliations
摘要 Abstract
中文摘要
背景：
在肿瘤学试验中，各研究中心对不良事件（AE）、方案偏离（PD）和疗效评估的审查方式存在差异，这可能延迟对新出现问题的发现——尤其是在团队分散的全球性研究中。为解决这一问题，Premier Research 部署了 Remarque，这是一个专有的、技术赋能的数据监督平台，用于集中管理试验情报、规范审查工作流程，并近乎实时地掌握患者安全与数据质量。
方法：
Remarque 将各类临床和运营数据流整合到统一的环境中。可配置的分析、仪表板和内置审计追踪功能，使临床运营、数据管理、中央监查以及医学/安全审查在单一、可追溯的流程上保持一致。核心功能包括标准化审查模板、针对 AE 聚集的数据驱动警报、可定制的安全性与有效性数据视图，以及支持检查准备就绪的可追溯文档。Remarque 已在 30 余项肿瘤学研究中部署，涵盖新型疗法和首创产品（first-in-class），跨越不同地域。
结果：
Remarque 的部署使常见安全模式得以更早发现，包括低级别毒性的聚集和 AE 录入延迟。使用该平台的研究实现了更快的信号到行动时间，以及更为一致的 AE 审查。中央监查与医学监查之间近乎实时的协作，使潜在的入组资格问题得以更早标记，从而减少了与入组资格相关的不合规情况。对研究中心内部及各中心之间数据模式趋势进行分析的能力，使得对研究中心执行关键流程（如 AE 采集）的监控成为可能，将 AE 漏报的检出时间从平均 4-6 周缩短至 5-7 天。值得注意的是，Remarque 中央监查识别出所发生 PD 的 55%，并将从 PD 发生到识别的时间缩短了 20%。集中化的可追溯性增强了监管审查中数据的可辩护性，并促进了对反复出现的数据质量问题的主动整改。总体而言，这带来了更洁净的数据、高效的患者安全管理以及更高的患者保留率。
结论：
技术驱动的监督模式提升了肿瘤学试验中数据审查的可靠性、透明度和及时性。通过以标准化框架取代碎片化流程，Remarque 实现了更早的信号检测、减少了差异并改善了数据质量。这一方法体现了整合式数字基础设施如何增强临床与医学监督，并支持在保护患者的同时加速在全球范围内高效交付有效的癌症疗法这一目标。
查看英文原文 English abstract
Background:
Variability in how adverse events (AE), protocol deviations (PD), and response assessments are reviewed across sites can delay detection of emerging issues in oncology trials-especially in global studies with dispersed teams. To address this, Premier Research implemented Remarque, a proprietary, technology-enabled data oversight platform to centralize trial intelligence, standardize review workflows, and provide near-real-time visibility into patient safety and data quality.
Methods:
Remarque integrates various clinical and operational data streams into a unified environment. Configurable analytics, dashboards, and built-in audit trails align clinical operations, data management, central monitoring, and medical/safety review on a single, traceable process. Key features include standardized review templates, data-driven alerts for AE clusters, customizable views of safety and efficacy data, and traceable documentation to support inspection readiness. Remarque was deployed across more than 30 oncology studies including novel therapeutics and first-in-class products, spanning different geographies.
Results:
Deployment of Remarque enabled earlier detection of common safety patterns, including clusters of low-grade toxicities and delayed AE entry. Studies using the platform achieved faster signal-to-action time and more consistent AE review. Near-real-time collaboration between central monitoring and medical monitoring allowed earlier flagging of potential eligibility concerns, decreasing eligibility-related non-compliance. Ability to trend data patterns within and across sites allowed for monitoring of site's execution of critical processes such as AE capture, reducing time to detection of AE underreporting from an average of 4-6 weeks down to 5-7 days. Notably, Remarque central monitoring identified 55% of PDs that occurred, with a 20% reduction in time from PD occurrence to identification. Centralized traceability strengthened data defensibility for regulatory review and facilitated proactive remediation of recurring data-quality findings. Overall, this resulted in cleaner data, efficient patient safety management, and improved patient retention.
Conclusions:
A technology-driven oversight model improved the reliability, transparency, and timeliness of data review in oncology trials. By replacing fragmented processes with a standardized framework, Remarque enabled earlier signal detection, reduced variability, and improved data quality. This approach reflects how integrated digital infrastructure enhances clinical and medical oversight and supports the goal of safeguarding patients while accelerating efficient delivery of effective cancer therapies globally.
利益披露 Disclosure
A. Herrick, None..
D. Berman, None..
E. Haeuber, None..
S. Shah, None..
S. Naidu, None.