COVID-19: Connection and Cooperation

COVID-19:连接与合作

2020-03-26 19:40 lionbridge

本文共958个字,阅读需10分钟

阅读模式 切换至中文

A pandemic is by definition a global challenge. The COVID-19 crisis has visibly taken its toll across all continents, impacting healthcare systems, business communities, news platforms and even our private homes. By now, most of us have grasped the severity of the situation and how our pre-crisis lifestyles and social mobility need to change to slow the transmission of communicable diseases. Our social and professional lives are rewritten with each new government recommendation and we rely on technology and social media to interact and exchange information these days. Just this week, my family had our Sunday dinner over Facetime from six different locations in three different countries. Under these exceptional circumstances, will our global community become more isolated or more interconnected? Are we going to see a permanent boost in the use of technology and virtual business conduct? With the global community busy focusing on emergency care and minimizing the transmission of COVID-19 and the disruption of our healthcare systems, no one knows the answers to these questions. While we could blame our interconnected world for the rapid spread of the coronavirus, we can also harness this interconnectivity to help bring a cure and mitigate the impact of COVID-19 or any other future pandemic for that matter. Effective solutions to handle pandemics rely on a complicated marriage of research, technology, innovation, solidarity, monetary funds and global infrastructure. We are currently witnessing the honeymoon of this global marriage as governments, research communities and healthcare systems pull together at an impressive speed to help COVID-19 patients and to maintain ongoing research for the development of critical new therapies for unmet medical needs. On March 19, the World Health Organization’s (WHO) Regional Director for Europe called for global solidarity and continued collaboration across countries in Europe to allow the flow of critical supplies across closed borders. WHO has established a Solidarity Response Fund and released a tool for behavioral insights during the COVID-19 crisis to help governments respond rapidly, flexibly and cost-effectively. The situational reports continuously released by the WHO confirm how the new coronavirus spreads worldwide. As of March 25, situational numbers included 414,179 confirmed cases and 18,440 deaths in total with the current European epicenter accounting for 220,516 cases and 11,986 deaths. These numbers continue to rise every day. The research community and regulatory health authorities are doing their part by fast tracking R&D efforts and regulatory pathways to expedite development of new treatment options for COVID-19 and to alleviate the impact on patients and healthcare systems in general. In addition, while the airspace is closed for passengers, the air freight industry is working around the clock and offers expedited logistics as well as monetary relief to bring critical medical equipment to healthcare professionals and patients around the world. On March 18, the American Food and Drug Administration (FDA) published a guidance to industry on how to conduct clinical trials during the COVID-19 pandemic and to minimize the disruption of ongoing clinical programs. The European Medicines Agency (EMA) followed on March 20 with a similar guidance for trial sponsors conducting clinical trials in Europe. The intent of the guidances is to minimize the interruption of important ongoing clinical programs, but first and foremost to protect the safety of trial participants without compromising the quality of the data obtained in clinical trials. With the restrictions enforced upon infrastructure and our general mobility, it is very difficult to carry through trial procedures, site visits, monitoring, consent procedures and physical examinations. Both FDA and EMA have therefore encouraged trial sponsors to find alternatives to physical trial visits for non-critical procedures, e.g. by use of phone or video visits. Also, the regulators have opened up for monitoring to be replaced by remote source data verification to reduce onsite visits. On March 19, the EMA published a statement urging the EU research community to prioritize large scale controlled clinical studies for potential treatments for COVID-19 to generate the necessary efficacy and safety data for such new drugs. In the same statement, trial sponsors were encouraged to include all EU countries in these trials to speed up drug development. The geographic footprint of clinical trials is likely to expand as a result. The classical phase III trial often enrolls only a handful of countries in Europe including Member States in the ”big five;” also know as the EU5 (Germany, France, Italy and Spain, now excluding the UK) and a couple of countries in Eastern Europe or the Nordic region. Conducting trials in all EU Member States within the same protocol will be a significant expansion and require effective communication across 24 different languages. Multinational Trial Conduct Brings Language Challenges Especially in a multilingual region such as Europe, clinical trial conduct requires content in many local languages. The current situation calls not only for more translations but also for extremely rapid translations to match the fast-tracking initiatives of regulators and industry. For COVID-19 treatments, we are likely to see large multinational programs enrolling patients across continents. For ongoing multinational clinical programs, more content will need translation to manage protocol changes, deviations, changed consent procedures and patient information. And different technology platforms can enable virtual trial conduct and replace paper with electronic data capture. Lionbridge has the scale to match expedited clinical trial programs extending across all continents and languages. Centralizing translations for a full clinical program with Lionbridge enables optimized trial conduct and decreases delays. With the Lionbridge suite of multimedia solutions coupled with translations and interpretation services, we can support virtual trial conduct and reduce the disruption of clinical trial execution. Our continuing mission is to build bridges and break down barriers; that commitment stays strong in the face of any medical uncertainty.   Get in Touch Lionbridge has a plan for emergency communications. Access our crisis resources center.
从定义上讲,大流行病是一项全球性挑战。COVID-19危机已明显影响到所有大陆,影响到医疗系统、商业社区、新闻平台,甚至我们的私人住宅。到目前为止,我们大多数人已经掌握了形势的严重性,以及我们危机前的生活方式和社会流动性需要如何改变,以减缓传染病的传播。我们的社会和职业生活被每一个新的政府建议改写,我们依靠技术和社会媒体来互动和交流信息。就在这个星期,我的家人在三个不同国家的六个不同地点举行了我们的周日晚餐。 在这些特殊情况下,我们的全球社会是否会变得更加孤立或相互关联?我们是否会看到技术和虚拟商业行为的使用会得到永久性的提升?由于全球社会正忙于紧急护理和尽量减少 COVID-19的传播以及我们的医疗系统的中断,没有人知道这些问题的答案。 虽然我们可以将冠状病毒的迅速传播归咎于我们相互联系的世界,但我们也可以利用这种相互联系来帮助治愈和减轻 COVID-19或任何其他未来大流行的影响。有效解决流行病的办法依赖于研究、技术、创新、团结、货币基金和全球基础设施的复杂结合。目前,我们正见证着这场全球婚姻的蜜月期,各国政府、研究机构和医疗系统正以令人印象深刻的速度携手合作,帮助 COVID-19患者,并继续进行研究,为尚未满足的医疗需求开发新的关键疗法。 3月19日,世界卫生组织(世卫组织)欧洲区域主任呼吁全球团结一致,并继续在欧洲各国之间开展协作,以允许关键物资跨越封闭边界流动。世卫组织建立了一个团结响应基金,并发布了一个工具,用于在 COVID-19危机期间的行为洞察,以帮助各国政府迅速、灵活和经济高效地作出反应。世卫组织不断发布的形势报告证实了新的冠状病毒在世界范围内的传播。截至3月25日,情况数字包括414179例确诊病例和18440例死亡,目前欧洲震中占220516例,11986例死亡。这些数字每天都在增加。 研究界和监管卫生当局正在尽其所能,快速跟踪研发工作和监管途径,以加快开发新的 COVID-19治疗方案,并总体上减轻对患者和医疗系统的影响。此外,尽管空域对乘客关闭,但航空货运业正在昼夜不停地工作,并提供快速的物流和货币救济,以便为世界各地的医疗保健专业人员和病人带来关键的医疗设备。 3月18日,美国食品和药物管理局( FDA )就如何在 COVID-19大流行期间进行临床试验和尽量减少正在进行的临床试验的中断向业界发布了一份指南。欧洲药品管理局( EMA )随后于3月20日向在欧洲进行临床试验的试验发起人提供了类似的指南。指南的目的是尽量减少重要的临床项目的中断,但首先要保护试验参与者的安全,同时不损害临床试验中获得的数据的质量。 由于对基础设施的限制和我们的一般流动性,很难进行审判程序、现场视察、监测、同意程序和体检。因此, FDA 和 EMA 都鼓励试验赞助商寻找非关键程序的物理试验访问的替代方案,例如通过电话或视频访问。此外,监管机构还开放了监控系统,将其替换为远程源数据验证,以减少现场访问。 3月19日,欧洲药品管理局发表声明,敦促欧盟研究界优先考虑 COVID-19潜在治疗方法的大规模受控临床研究,以便为此类新药生成必要的疗效和安全性数据。在同一份声明中,鼓励试验赞助者将所有欧盟国家纳入这些试验,以加快药物开发。因此,临床试验的地理足迹可能会扩大。 经典的第三阶段试验通常只招收少数欧洲国家,包括“五大”成员国,也被称为欧盟5(德国、法国、意大利和西班牙,现在不包括英国)以及东欧或北欧地区的几个国家。在同一议定书范围内在所有欧盟成员国进行审判将是一项重大的扩展,需要在24种不同语言之间进行有效的交流。 跨国审判行为带来语言挑战 特别是在欧洲这样的多语种地区,临床试验行为需要使用多种当地语言的内容。目前的情况不仅要求翻译更多,而且要求翻译速度极快,以配合监管机构和行业的快速跟踪举措。对于 COVID-19治疗,我们可能会看到大型跨国项目,在各大洲招收患者。对于正在进行的跨国临床项目,更多的内容将需要翻译来管理协议变更、偏差、变更同意程序和患者信息。而不同的技术平台可以实现虚拟实验的进行,并用电子数据捕获代替纸张. Lionbridge 的规模与快速的临床试验计划相匹配,扩展到所有大陆和语言。使用 Lionbridge 对完整的临床程序进行集中翻译,可以优化试验行为并减少延迟。借助 Lionbridge 的多媒体解决方案套件以及翻译和口译服务,我们可以支持虚拟试验行为,并减少临床试验执行的中断。我们的持续使命是建立桥梁,打破障碍;面对任何医疗方面的不确定性,我们的承诺依然坚定。 进入 Touch Lionbridge 有紧急通讯计划。进入我们的危机资源中心。

以上中文文本为机器翻译,存在不同程度偏差和错误,请理解并参考英文原文阅读。

阅读原文