Statistical Methods for Quantitative Decision-Making in Vaccines Development

This manuscript introduces and discusses the Quantitative Decision-Making (QDM) statistical framework and its application in vaccine development. The QDM framework encourages researchers to set clear success criteria and enables decision-makers to evaluate the risk associated with endorsing a particular study and investing in the further development of the asset. This is achieved through the computation of the Probability of Success (PoS) of a study, which measures the likelihood to meet certain pre-specified criteria. The paper discusses the challenges encountered in vaccine trials and outlines strategies for managing multiple endpoints and surrogate endpoints. The paper provides some case studies to illustrate some concepts and concludes with a discussion on the general approach.