Leveraging implementation science in clinical trials of vaccines in the global south

Abstract

Infectious diseases have a major impact on the global economy and politics, as exemplified by the COVID-19 pandemic, so investigational vaccines and immunization technologies often need to be rapidly developed and adopted for use in humans within the shortest possible time.

One way to achieve this is by proactively leveraging implementation science from the early stages of clinical development through to regulatory approval and clinical use. The need for implementation science applies to vaccines, as well as to innovations or technologies that can improve vaccination coverage, such as the microneedle patch¹, for which an early stage clinical trial in The Gambia has demonstrated safety and immunogenicity in delivering the vaccine against measles and rubella¹. There is always a risk in biomedical science that investigational products such as vaccines and immunization-related innovations become trapped in the chasm between research and practice. Implementation science, defined as “the scientific study of methods to promote the systematic uptake of research findings and other evidence-based practices into routine practice, and, hence, to improve the quality and effectiveness of health services”², emerged out of the need to shorten the know–do gaps of health interventions³. This field of study promotes a better understanding of context and how it affects implementation outcomes, and has several multidisciplinary and theory-informed frameworks and models for navigating multifaceted complex processes³. Although implementation science research has been mostly focused on the T3 phase (translation to practice) and T4 phase (translation to community) of the translational science continuum, it can also be applied in the early stages of a clinical trial in the T1 phase (translation to humans) and T2 phase (translation to patients) to improve successful and timely trial execution.