The FEEVA team are conducting a Delphi survey to ascertain the best path forward as we work towards a framework for evidence evaluation in vaccine assessment.
The overall purpose of the FEEVA project is to develop a structured, consensus-based framework to guide the assessment, interpretation and reporting of preclinical evidence used in vaccine development and approvals. Given the complexity of vaccine development and the need for harmonisation across scientific and regulatory domains, the Delphi method will be used to develop this framework, starting with a two-round survey on animal studies.
We are seeking participants who can offer informed, experience-based perspectives on preclinical vaccine research using animal models and evidence assessment. We would highly value participants’ thoughts on the relevance and understanding of two key concepts related to animal studies.
The first concept centres around the fact that animals are not humans. Even well-designed animal studies may only partly reflect how a vaccine will work in people. In this survey we use the term indirectness to describe this phenomenon. When using animal studies to support vaccine development, indirectness is almost always a consideration, but to what extent is it relevant or needing to be understood?
Secondly, animal studies are often an early step in deciding whether a vaccine should move forward to human trials. The survey asks for your thoughts on risk of bias in animal studies. In this case, the term ‘risk of bias’ refers to the possibility that the way a study is designed, carried out, or reported has introduced systematic errors that push the results away from the truth. It doesn’t necessarily mean the researchers did anything wrong – it can arise from unavoidable limitations in study methods. How relevant is this concept for animal studies?
We hope to gather a broad range of perspectives from diverse populations and are inviting experts from academia, industry, and regulatory agencies with experience in fields such as immunology, infectious diseases, vaccine development, evidence synthesis, translational research, and regulatory science.
Find out more and complete the survey
