對(duì)于迅速演變的流行病來說，僅開展傳統(tǒng)臨床試驗(yàn)還是不能及時(shí)得到有意義的研究結(jié)果。在未來更好地應(yīng)對(duì)流行病暴發(fā)，可能需要接受一種靈活的試驗(yàn)設(shè)計(jì)，這種設(shè)計(jì)可以繞過、加速或重新安排傳統(tǒng)的3個(gè)臨床研究階段，同時(shí)又遵循候選藥物安全性和有效性相關(guān)的科學(xué)規(guī)律。介紹了治療新型冠狀病毒肺炎（COVID-19）的8個(gè)適應(yīng)性臨床試驗(yàn)，及1個(gè)平臺(tái)試驗(yàn)，同時(shí)還列舉了2個(gè)疫苗研發(fā)的由真實(shí)世界證據(jù)（RWE）和隨機(jī)對(duì)照試驗(yàn)（RCT）組成的混合設(shè)計(jì)方案。為了有效應(yīng)對(duì)流行病，鼓勵(lì)新型的臨床試驗(yàn)設(shè)計(jì)，鼓勵(lì)疫苗開發(fā)的新型研究策略。建議為未來可能發(fā)生的流行病制定藥物研發(fā)計(jì)劃，以進(jìn)行適應(yīng)性的、持續(xù)的、多地區(qū)的臨床研究。

For rapidly evolving epidemics, only conducting traditional clinical trials can not get meaningful research results in time. In the future, to better respond to epidemic outbreaks, it may be necessary to accept a flexible trial design that can bypass, accelerate, or rearrange the traditional three clinical research stages, while at the same time complying with scientific laws related to the safety and effectiveness of drug candidates. This article introduces 8 adaptive clinical trials for the treatment of new coronavirus diseases, and 1 platform trial. Two hybrid designs of real world evidence (RWE) and randomized controlled trials (RCT) for vaccine development are presented. In order to effectively respond to epidemics, innovative clinical trial design and novel research strategies for vaccine development are encouraged. It is recommended to formulate drug development plans for future epidemic diseases in order to conduct adaptive, continuous, and multi-regional clinical research.