An information theoretic approach for the evaluation of correlates of protection in a vaccine setting. (R-10572)

Evaluating the protective efficacy of a vaccine without having to measure clinical endpoints has significant advantages and immunological endpoints, also called surrogates of protection (SoP), are often used for vaccine development, licensure and effectiveness monitoring. SoP have played an important role in the development of many of the current childhood combination vaccines. However, SoP need to be evaluated before they can be reliably used to assess the protection efficacy of new vaccines. This evaluation is particularly challenging at the beginning of the vaccine developing process when only data from one (or a few) clinical trials are available. Often, in this scenario, scientifically problematic methods like Prentice's criteria or the proportion of treatment explained are still widely used to assess the validity of SoP. The main objective of this project is the development of a scientifically sound approach for the evaluation of SoP based on information theory. The methodology will be designed to be applied in the early stages of the vaccine developing process and will offer an intuitive and easy to interpret metric that would allow trialists and clinicians (at GSK and other stakeholders involved in the project) to better assess and understand the validity of a SoP for a given vaccine, enabling faster and cheaper vaccine development. All procedures will be implemented in the freely available R library Surrogate.

Keywords:CLINICAL TRIALS

Disciplines:Public health sciences not elsewhere classified, Other health sciences not elsewhere classified, Other medical and health sciences not elsewhere classified