When SARS-CoV-2 emerged at the end of 2019, no approved therapeutics or vaccines were available. An urgent need for countermeasures during this crisis challenges the current paradigm of traditional drug discovery and development, which usually takes years from start to finish. Approaches that accelerate this process need to be considered. Here we propose the minimum data package required to move a compound into clinical development safely. We further define the additional data that should be collected in parallel without impacting the rapid path to clinical development. Accelerated paths for antivirals, immunomodulators, anticoagulants, and other agents have been developed and can serve as “roadmaps” to support prioritization of compounds for clinical testing. These accelerated paths are fueled by a skewed risk-benefit ratio and are necessary to advance therapeutic agents into human trials rapidly and safely for COVID-19. Such paths are adaptable to other potential future pandemics.

2019 年底 SARS-CoV-2 出现时，还没有批准的治疗方法或疫苗。这场危机期间迫切需要采取对策，这对当前传统药物发现和开发的范式提出了挑战，而传统药物发现和开发通常从开始到完成需要数年时间。需要考虑加速这一过程的方法。在这里，我们提出了将化合物安全地投入临床开发所需的最低数据包。我们进一步定义了应并行收集的额外数据，而不影响临床开发的快速路径。抗病毒药物、免疫调节剂、抗凝血剂和其他药物的加速路径已经开发出来，可以作为支持临床测试化合物优先顺序的“路线图”。这些加速路径是由不平衡的风险收益比推动的，对于将治疗药物快速、安全地推进到 COVID-19 的人体试验中是必要的。此类路径适用于未来其他潜在的流行病。