Center for Pharmacoepidemiology and Treatment Science, Rutgers University, New Brunswick, New Jersey, USA.
Ernest Mario School of Pharmacy, Rutgers University, Piscataway, New Jersey, USA.
Pharmacoepidemiol Drug Saf. 2022 Jun;31(6):710-715. doi: 10.1002/pds.5429. Epub 2022 Mar 31.
Early into COVID, human challenge trials were considered, but usually as alternatives to conventional randomized controlled trials. Instead, assessment of authorized COVID vaccines, of further COVID vaccines, and of vaccines against future pandemics should combine both designs, in five different ways, including a wholly novel one that we elaborate, Viz., combining data from both designs to answer a single question.
在 COVID 早期，人们考虑进行人体挑战试验，但通常将其作为传统随机对照试验的替代方法。相反，对已授权的 COVID 疫苗、进一步的 COVID 疫苗以及针对未来大流行的疫苗的评估应该结合这两种设计，以五种不同的方式进行，包括我们详细阐述的一种全新方式，即结合来自这两种设计的数据来回答一个单一的问题。
