Real-world studies (RWS) have emerged as post-market surveillance approach to assess performance of existing drugs. RWS tend to supplement RCTs, in particular of those with accelerated regulatory approval [3, 5].

Real-world data (RWD) refer to data collected from diversified areas of daily life that are outside the scope of highly controlled randomized control trials (RCTs). 1 Examples of RWD are the large quantities of data collected broadly through the use of a diverse range of medical devices by various users, including self-checked glucometer or sphy...

This article aimed at providing a comprehensive analysis of the role of RWS in clinical evidence generation in head and neck cancer compared with traditional RCT, and identifying potential factors associated with evidence generation by reviewing RWS and traditional RCT publications in head and neck cancer from PubMed between 2010 and 2020.

Mar 1, 2018 · RWS have a broader and more representative scope than randomized controlled trial (RCT) (Roy-Byrne et al., 2003 1). We discuss how the medical Internet of Things (IoT) (Bai, 2014 2) helps RWS overcome its shortcomings while satisfying real-world evidence (RWE) requirements (Sherman et al., 2014 3).

The composite likelihood approach is implemented as a down-weighing strategy to account for the impact of high variability in RWS population. An optimal sample size determination procedure for RCT and RWS is introduced, aiming to achieve the minimal expected sample size.

Jan 8, 2020 · In recent years, real-world studies (RWS) are gaining increasing interests, because they can generate more realistic and generalizable results than randomized controlled clinical trials (RCT). In 2017, we published a RCT in 741 early …

May 20, 2020 · In addition, a seamless design connecting RCT and RWS is preferable, and the agreement on the results and conclusions between the RCT and RWS can offer stronger evidence for the validity...

Real-world study (RWS) is a method to draw conclusions by collecting and analyzing real-world data under a real clinical background.

真实世界研究（Real World Study，RWS；Real World Research，RWR），即在真实世界环境下收集与患者有关的数据（RWD），通过分析，获得医疗产品的使用价值及潜在获益或风险的临床证据（RWE），主要研究类型是观察性研究，也可以是临床试验。 真实世界研究是起源于实用性的临床试验，特点是在较大的样本量基础上，根据患者的实际病情和意愿选择治疗措施，开展长期评价，并注重有意义的结局治疗。 真实世界研究是从传统循证临床科研以外的多个数据集中挖 …

RWS和RCT的区别不是试验设计和研究方法，而是研究实施场景。 RWS须从临床问题的确定、现有数据情况的评估切入，采用既往回顾性数据或是前瞻性采集数据，进一步到研究设计的选择以及统计分析方法的确定、数据管理、统计分析、结果解读和评价，以及根据需求判断是否加入事后分析（posthoc analysis）。 真实世界研究是对临床常规产生的真实世界数据进行系统性收集并进行分析的研究，其研究可随机或非随机，可回顾，可观察，也可前瞻。 目前，在ClinicalTrials …