Update Oct. 7, 2020
During the first wave, of the COVID crisis, we learned that social distancing and lockdown measures posed significant challenges to recruitment and on-time initiation of site-based studies. As we head into the second wave, it is even more imperative to develop strategies and effective solutions to ensure the generation of robust RWE even amidst this pandemic.
以下文章最初于今年4月撰写，提出了一种使用二级数据来源来支持研究的方法。随着COVID-19感染的第二波浪潮威胁要恢复锁定措施并加强对社交互动的严格规则，使用数据库研究来进行研究一如既往。如果研究人员和医疗保健站点需要更严格的研究限制以管理大流行造成的持续不确定性，则这种方法可以为研究赞助商提供可行的方法，以继续进行现实世界研究。lol买外围用什么软件
During these unprecedented times, when the global healthcare system is dealing with the COVID-19 pandemic and resources are being redirected to support frontline care, access to researchers is more restrictive. Meanwhile, social distancing and physical distancing restrictions put in place for the safety of our communities mean that patients are only visiting their physicians when necessary, resulting in disruptions or delays to ongoing, non-priority studies.
如何ever, the need for Real World Evidence (RWE) continues to be a critical component of decision making, despite the current challenges in conducting site-based research.
Healthcare stakeholders and decision makers are increasingly relying on evidence derived from Real World Data (RWD) to guide and help influence decisions ranging from regulatory approval, to reimbursement, to treatment decisions in the clinic.
在当前情况之前，已经发生了逐渐的范式转变，支持审查产品生命周期早期的药物有效性和安全性，以促进以加快方式使用药物，尤其是对于稀有疾病和肿瘤学。
The challenge of site burden is not a new issue。每年全球平均有54种新的活性物质，并且实施成本遏制措施，与竞争者区分开的需求越来越重要。基于站点的RWE研究可能会耗时，昂贵，并且涉及高度的行政负担。后一个因素已经被证明对于研究人员参与这些研究的意愿至关重要。
