真实世界观察研究的适应性通用原则(AUPROS):一种为临床、流行病学和精准肿瘤学研究设计真实世界观察研究的方法。

IF 6.4 1区 医学 Q1 ONCOLOGY
Samir H Barghout, Nicholas Meti, Simren Chotai, Christina J H Kim, Devalben Patel, M Catherine Brown, Katrina Hueniken, Luna J Zhan, Stavroula Raptis, Faisal Al-Agha, Christopher Deutschman, Benjamin Grant, Martha Pienkowski, Patrick Moriarty, John de Almeida, David P Goldstein, Scott V Bratman, Frances A Shepherd, Ming S Tsao, Andrew N Freedman, Wei Xu, Geoffrey Liu
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引用次数: 0

摘要

精准肿瘤学领域取得了多项进展,促进了新型临床试验设计的发展,真实世界数据(RWD)也成为医疗决策中生成证据的重要资源。在此,我们将重点介绍我们在采用一套用于真实世界观察研究的适应性通用原则(AUPROS)的创新方法方面的经验。为了证明这些原则的实用性,我们采用混合方法评估了玛格丽特公主癌症中心遵循 AUPROS 的三项研究:(1) 胸部病变分子流行病学研究 (METAL);(2) 头颈部转化研究 (THANKS);(3) 加拿大罕见分子变异肿瘤研究 (CARMA;NCT04151342)。我们进行了资源评估、利益相关者调查和讨论、资金分析、研究成果、合作以及优势-劣势-机会-威胁(SWOT)分析。基于这些分析,AUPROS 是一种适用于各种观察研究设计的方法。AUPROS 的通用性允许对各种 RWD 进行多用途分析,其适应性为多方筹资和合作创造了机会。遵循 AUPROS 可以带来成本和后勤方面的优势,并可能提高研究效率。在伦理审批、可持续性、复杂的协调和数据质量方面发现了一些挑战,需要对这些原则进行本地化调整。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Adaptive Universal Principles for Real-world Observational Studies (AUPROS): an approach to designing real-world observational studies for clinical, epidemiologic, and precision oncology research.

The field of precision oncology has witnessed several advances that stimulated the development of new clinical trial designs and the emergence of real-world data (RWD) as an important resource for evidence generation in healthcare decision-making. Here, we highlight our experience with an innovative approach to a set of Adaptive, Universal Principles for Real-world Observational Studies (AUPROS). To demonstrate the utility of these principles, we used a mixed-methods approach to assess three studies that follow AUPROS at Princess Margaret Cancer Centre: (1) Molecular Epidemiology of ThorAcic Lesions (METAL), (2) Translational Head And NecK Study (THANKS), and (3) CAnadian CAncers With Rare Molecular Alterations (CARMA; NCT04151342). We performed resource assessments, stakeholder-directed surveys and discussions, analysis of funding, research output, collaborations, and a Strengths-Weaknesses-Opportunities-Threats (SWOT) analysis. Based on these analyses, AUPROS is an approach that is applicable to a wide range of observational study designs. The universality of AUPROS allows for multi-purpose analyses of various RWD, and the adaptive nature creates opportunities for multi-source funding and collaborations. Following AUPROS can offer cost and logistical benefits and may lead to increased research productivity. Several challenges were identified pertinent to ethics approvals, sustainability, complex coordination, and data quality that require local adaptation of these principles.

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来源期刊
British Journal of Cancer
British Journal of Cancer 医学-肿瘤学
CiteScore
15.10
自引率
1.10%
发文量
383
审稿时长
6 months
期刊介绍: The British Journal of Cancer is one of the most-cited general cancer journals, publishing significant advances in translational and clinical cancer research.It also publishes high-quality reviews and thought-provoking comment on all aspects of cancer prevention,diagnosis and treatment.
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