Benefit-Risk Assessment of Vaccines. Part II: Proposal Towards Consolidated Standards of Reporting Quantitative Benefit-Risk Models Applied to Vaccines (BRIVAC)

Arlegui, Hugo; Bollaerts, Kaatje; Bauchau, Vincent; Nachbaur, Gaëlle; Bégaud, Bernard; Praet, Nicolas

doi:10.1007/s40264-020-00982-9

Cited by 9 publications

(4 citation statements)

References 66 publications

(102 reference statements)

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“… 24 25 30 33 47 61 63 69 73 77 81 84 94 95 We also identified six systematic reviews on BRA methods, 1 3 19 32 37 43 and one reporting guideline developed specifically for reporting of BRA of vaccines. 44 …”

Section: Resultsmentioning

confidence: 99%

Methodological guidelines and publications of benefit–risk assessment for health technology assessment: a scoping review

Suzumura,

de Oliveira Ascef,

Maia

et al. 2024

BMJ Open

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ObjectivesTo map the available methodological guidelines and documents for conducting and reporting benefit–risk assessment (BRA) during health technologies’ life cycle; and to identify methodological guidelines for BRA that could serve as the basis for the development of a BRA guideline for the context of health technology assessment (HTA) in Brazil.DesignScoping review.MethodsSearches were conducted in three main sources up to March 2023: (1) electronic databases; (2) grey literature (48 HTA and regulatory organisations) and (3) manual search and contacting experts. We included methodological guidelines or publications presenting methods for conducting or reporting BRA of any type of health technologies in any context of the technology’s life cycle. Selection process and data charting were conducted by independent reviewers. We provided a structured narrative synthesis of the findings.ResultsFrom the 83 eligible documents, six were produced in the HTA context, 30 in the regulatory and 35 involved guidance for BRA throughout the technology’s life cycle. We identified 129 methodological approaches for BRA in the documents. The most commonly referred to descriptive frameworks were the Problem, Objectives, Alternatives, Consequences, Trade-offs, Uncertainty, Risk and Linked decisions and the Benefit–Risk Action Team. Multicriteria decision analysis was the most commonly cited quantitative framework. We also identified the most cited metric indices, estimation and utility survey techniques that could be used for BRA.ConclusionsMethods for BRA in HTA are less established. The findings of this review, however, will support and inform the elaboration of the Brazilian methodological guideline on BRA for HTA.Trial registration numberhttps://doi.org/10.17605/OSF.IO/69T3V.

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Section: Resultsmentioning

confidence: 99%

Methodological guidelines and publications of benefit–risk assessment for health technology assessment: a scoping review

Suzumura,

de Oliveira Ascef,

Maia

et al. 2024

BMJ Open

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“…The study was done in accordance with standards of reporting quantitative benefit-risk models applied to vaccines (BRIVAC) guideline. 40 …”

Section: Methodsmentioning

confidence: 99%

GLP-1 receptor agonists for weight reduction in people living with obesity but without diabetes: a living benefit–harm modelling study

Moll,

Frey,

Gerber

et al. 2024

eClinicalMedicine

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“…A risk management plan needs to be developed [ 29 ] when the vaccine is submitted for licensure. Increasingly, vaccine manufacturers incorporate a benefit–risk analysis to support policy decision-makers [ 30 , 31 ]. Streptococcus pyogenes vaccines are likely to be licensed and developed in high-income countries and deployed in LMICs.…”

Section: Regulatory Perspectives To Inform Safety Strategiesmentioning

confidence: 99%

Safety of Streptococcus pyogenes Vaccines: Anticipating and Overcoming Challenges for Clinical Trials and Post-Marketing Monitoring

Asturias

Excler

Ackland³

et al. 2023

Clinical Infectious Diseases

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Streptococcus. pyogenes (Strep A) infections result in a vastly underestimated burden of acute and chronic disease globally. The Strep A Vaccine Global Consortium (SAVAC) mission is to accelerate the development of safe, effective and affordable S. pyogenes vaccines. The safety of vaccine recipients is of paramount importance. A single S. pyogenes vaccine clinical trial conducted in the 1960s raised important safety concerns. A SAVAC Safety Working Group was established to review the safety assessment methodology and results of more recent early phase clinical trials and to consider future challenges for vaccine safety assessments across all phases of vaccine development. No clinical or biological safety signals were detected in any of these early phase trials in the modern era. Improvements in vaccine safety assessments need further consideration, particularly for pediatric clinical trials, large-scale efficacy trials, and preparation for post-marketing pharmacovigilance.

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Benefit-Risk Assessment of Vaccines. Part II: Proposal Towards Consolidated Standards of Reporting Quantitative Benefit-Risk Models Applied to Vaccines (BRIVAC)

Cited by 9 publications

References 66 publications

Methodological guidelines and publications of benefit–risk assessment for health technology assessment: a scoping review

Methodological guidelines and publications of benefit–risk assessment for health technology assessment: a scoping review

GLP-1 receptor agonists for weight reduction in people living with obesity but without diabetes: a living benefit–harm modelling study

Safety of Streptococcus pyogenes Vaccines: Anticipating and Overcoming Challenges for Clinical Trials and Post-Marketing Monitoring

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