Dataset Information

Benefit-Risk Monitoring of Vaccines Using an Interactive Dashboard: A Methodological Proposal from the ADVANCE Project.

ABSTRACT:

Introduction

New vaccines are launched based on their benefit-risk (B/R) profile anticipated from clinical development. Proactive post-marketing surveillance is necessary to assess whether the vaccination uptake and the B/R profile are as expected and, ultimately, whether further public health or regulatory actions are needed. There are several, typically not integrated, facets of post-marketing vaccine surveillance: the surveillance of vaccination coverage, vaccine safety, effectiveness and impact.

Objective

With this work, we aim to assess the feasibility and added value of using an interactive dashboard as a potential methodology for near real-time monitoring of vaccine coverage and pre-specified health benefits and risks of vaccines.

Methods

We developed a web application with an interactive dashboard for B/R monitoring. The dashboard is demonstrated using simulated electronic healthcare record data mimicking the introduction of rotavirus vaccination in the UK. The interactive dashboard allows end users to select certain parameters, including expected vaccine effectiveness, age groups, and time periods and allows calculation of the incremental net health benefit (INHB) as well as the incremental benefit-risk ratio (IBRR) for different sets of preference weights. We assessed the potential added value of the dashboard by user testing amongst a range of stakeholders experienced in the post-marketing monitoring of vaccines.

Results

The dashboard was successfully implemented and demonstrated. The feedback from the potential end users was generally positive, although reluctance to using composite B/R measures was expressed.

Conclusion

The use of interactive dashboards for B/R monitoring is promising and received support from various stakeholders. In future research, the use of such an interactive dashboard will be further tested with real-life data as opposed to simulated data.

SUBMITTER: Bollaerts K

PROVIDER: S-EPMC6061437 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature

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Publications

Benefit-Risk Monitoring of Vaccines Using an Interactive Dashboard: A Methodological Proposal from the ADVANCE Project.

Bollaerts Kaatje K De Smedt Tom T Donegan Katherine K Titievsky Lina L Bauchau Vincent V

Drug safety 20180801 8

<h4>Introduction</h4>New vaccines are launched based on their benefit-risk (B/R) profile anticipated from clinical development. Proactive post-marketing surveillance is necessary to assess whether the vaccination uptake and the B/R profile are as expected and, ultimately, whether further public health or regulatory actions are needed. There are several, typically not integrated, facets of post-marketing vaccine surveillance: the surveillance of vaccination coverage, vaccine safety, effectiveness ...[more]

PMID: 29582392

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Project description:This contribution places itself within the emergency context of the COVID-19 spread. Until medical research identifies a cure acting at an organic level, it is necessary to manage what the emergency generates among the members of the Community in interactive terms in a scientific and methodologically well-founded way. This is in order to promote, among the members of the Community, the pursuit of the common aim of reducing the spread of infection, with a view to community health as a whole. In addition, being at the level of interactions enables us to move towards a change of these interactions in response to the COVID-19 emergency, in order to manage what will happen in the future, in terms of changes in the interactive arrangements after the emergency itself. This becomes possible by shifting away from the use of deterministic-causal references to the use of the uncertainty of interaction as an epistemological foundation principle. Managing the interactive (and non-organic) fallout of the emergency in the Community is made possible by the formalisation of the interactive modalities (the Discursive Repertories) offered by Dialogical Science. To place oneself within this scientific panorama enables interaction measurements: so, the interaction measurement indexes offers a range of generative possibilities of realities built by the speeches of the Community members. Moreover, the Social Cohesion measurement index, in the area of Dialogical Science, makes available to public policies the shared measure of how and by how much the Community is moving towards the common purpose of reducing the contagion spread, rather than moving towards other personal and not shared goals (for instance, having a walk in spite of the lockdown). In this index, the interaction between the Discursive Repertories and the "cohesion weight" associated with them offers a Cohesion output: the data allow to manage operationally what happens in the Community in a shared way and in anticipation, without leaving the interactions between its members to chance. In this way, they can be directed towards the common purpose through appropriate interventions relevant to the interactive set-up described in the data. The Cohesion measure makes it possible to operate effectively and efficiently, thanks to the possibility of monitoring the progress of the interventions implemented and evaluating their effectiveness. In addition, the use of predictive Machine Learning models, applied to interactive cohesion data, allows for immediate and efficient availability of the measure itself, optimising time and resources.

Project description:IntroductionUnderstanding the balance between the benefits and risks of vaccination is essential to ensure informed and adequate public health decision making. Quantitative benefit-risk models (qBRm) represent useful tools to help decision makers with supporting benefit-risk assessment throughout the lifecycle of a medical product. However, few initiatives have been launched to harmonise qBRm approaches, specifically for vaccines.ObjectivesThe aim of this paper was to identify publications about qBRm applied to vaccines through a systematic literature review, and to describe their characteristics.MethodsMedline, Scopus and Institute for Scientific Information Web of Knowledge databases were searched to identify articles in English, published from database inceptions up to December 2019. The search strategy included the combination of three key concepts: 'benefit-risk', 'modelling' and 'vaccines'. Data extracted included the modelling context and the methodological approaches used.ResultsOf 3172 publications screened, 48 original publications were included. Most of the selected studies were published over the past decade and focused on rotavirus (15), dengue (10) and influenza (6) vaccines. The majority (30) of studies reported analyses related to high-income countries. The methodology of the studies differed, particularly in modelling techniques, benefit-risk measures, and sensitivity analyses. The present work also pointed out a high level of variability in the quality of reporting across studies, with particular regard to input parameters and methodological approaches.ConclusionsThis review provides an extensive list of qBRm applied to vaccines. Discrepancies across studies were identified during our review. While the number of published qBRm studies is increasing, no reporting guidance for qBRm applied to vaccines is currently available. This may affect decision makers' confidence in the results and their benefit-risk assessment(s); therefore, the development of such reporting guidance is highly needed.

Project description:BackgroundMost randomized controlled trials (RCTs) in the academic setting have limited resources for clinical trial management and monitoring. Inefficient conduct of trials was identified as an important source of waste even in well-designed studies. Thoroughly identifying trial-specific risks to enable focussing of monitoring and management efforts on these critical areas during trial conduct may allow for the timely initiation of corrective action and to improve the efficiency of trial conduct. We developed a risk-tailored approach with an initial risk assessment of an individual trial that informs the compilation of monitoring and management procedures in a trial dashboard.MethodsWe performed a literature review to identify risk indicators and trial monitoring approaches followed by a contextual analysis involving local, national and international stakeholders. Based on this work we developed a risk-tailored management approach with integrated monitoring for RCTs and including a visualizing trial dashboard. We piloted the approach and refined it in an iterative process based on feedback from stakeholders and performed formal user testing with investigators and staff of two clinical trials.ResultsThe developed risk assessment comprises four domains (patient safety and rights, overall trial management, intervention management, trial data). An accompanying manual provides rationales and detailed instructions for the risk assessment. We programmed two trial dashboards tailored to one medical and one surgical RCT to manage identified trial risks based on daily exports of accumulating trial data. We made the code for a generic dashboard available on GitHub that can be adapted to individual trials.ConclusionsThe presented trial management approach with integrated monitoring enables user-friendly, continuous checking of critical elements of trial conduct to support trial teams in the academic setting. Further work is needed in order to show effectiveness of the dashboard in terms of safe trial conduct and successful completion of clinical trials.

Dataset Information

Benefit-Risk Monitoring of Vaccines Using an Interactive Dashboard: A Methodological Proposal from the ADVANCE Project.

Introduction

Objective

Methods

Results

Conclusion

Publications

Benefit-Risk Monitoring of Vaccines Using an Interactive Dashboard: A Methodological Proposal from the ADVANCE Project.

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