How agencies are changing standards in response to a global threat Multinational Efforts are Lifesavers in a Pandemic Age 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. Strengths and Weaknesses of an Interconnected World 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. What Are Industry, Regulators and Healthcare Organizations Doing? 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.