A public health emergency creates a challenging environment for the study of experimental vaccines, necessitating the need for novel, flexible and responsive trial designs. In a paper published July 3 in the journal Science Translational Medicine, a group of researchers led by University of Florida biostatistics faculty describes key considerations for the design and analysis of such trials.
“The most significant challenge during a public health emergency is that it is hard to design a study that places the vaccine in populations at high risk for the disease,” said lead author Natalie Dean, Ph.D., an assistant professor in the department of biostatistics at the UF College of Public Health and Health Professions and the UF College of Medicine. “In order to tell if the vaccine works, populations need to be naturally exposed, but for outbreaks, disease incidence is very unpredictable. Outbreaks may end quickly, before there is time to implement a clinical trial. We need new trial design strategies to address these challenges.”