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. 2019 Jul 18;37(31):4376-4381.
doi: 10.1016/j.vaccine.2019.06.019. Epub 2019 Jun 24.

An online decision tree for vaccine efficacy trial design during infectious disease epidemics: The InterVax-Tool

Steven E Bellan  1 , Rosalind M Eggo  2 , Pierre-Stéphane Gsell  3 , Adam J Kucharski  4 , Natalie E Dean  5 , Richard Donohue  6 , Matt Zook  6 , W John Edmunds  4 , Frank Odhiambo  7 , Ira M Longini Jr  5 , Marc Brisson  8 , Barbara E Mahon  9 , Ana Maria Henao-Restrepo  3
Affiliations

An online decision tree for vaccine efficacy trial design during infectious disease epidemics: The InterVax-Tool

Steven E Bellan et al. Vaccine. .

Abstract

Background: Licensed vaccines are urgently needed for emerging infectious diseases, but the nature of these epidemics causes challenges for the design of phase III trials to evaluate vaccine efficacy. Designing and executing rigorous, fast, and ethical, vaccine efficacy trials is difficult, and the decisions and limitations in the design of these trials encompass epidemiological, logistical, regulatory, statistical, and ethical dimensions.

Results: Trial design decisions are complex and interrelated, but current guidance documents do not lend themselves to efficient decision-making. We created InterVax-Tool (http://vaxeval.com), an online, interactive decision-support tool, to help diverse stakeholders navigate the decisions in the design of phase III vaccine trials. InterVax-Tool offers high-level visual and interactive assistance through a set of four decision trees, guiding users through selection of the: (1) Primary Endpoint, (2) Target Population, (3) Randomization Scheme, and, (4) Comparator. We provide guidance on how key considerations - grouped as Epidemiological, Vaccine-related, Infrastructural, or Sociocultural - inform each decision in the trial design process.

Conclusions: InterVax-Tool facilitates structured, transparent, and collaborative discussion of trial design, while recording the decision-making process. Users can save and share their decisions, which is useful both for comparing proposed trial designs, and for justifying particular design choices. Here, we describe the goals and features of InterVax-Tool as well as its application to the design of a Zika vaccine efficacy trial.

Keywords: Decision support system; Emerging infectious diseases; Epidemics; Outbreaks; Phase III trial; Public Health Emergency; Scientific communication; Vaccine trial design; Vaccines.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Schematic of InterVax-Tool’s decision process. Within each of four decision trees, users navigate a set of hierarchical decisions following guidance on how each of 14 key considerations affect the decision to pick one choice (blue rectangle) over another. During this process users take notes on the scenario under consideration as well as on their justifications for the decisions chosen through the four decision trees.
Fig. 2
Fig. 2
Screenshot of InterVax-Tool athttp://vaxeval.com. The decision tree with decisions and notes is presented on the top portion. The lower portion provides content on how relevant key considerations impact the active decision in the tree and provides the opportunity for users to take notes on each key consideration, building a description of the scenario during the process.
See this image and copyright information in PMC

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