ArticleFrontiers in medicine2021
Multi-Criteria Decision Analysis for Benefit-Risk Analysis by National Regulatory Authorities.
Article in Frontiers in medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
10 citing papers in PubMed, 25 citations in OpenAlex.
- Insights into the Complexities of Pharmacotherapy Parameters in Artificial Intelligence Models for Drug Selection, Precision Personalised Medicine and Optimal Therapeutic Outcomes.Pharmaceutics · 2026Review
- Axioms of Diagnostic Urgency: A Characterization Theorem.Entropy (Basel, Switzerland) · 2026Article
- Proof of concept studies in mental health systems research: strategy and steps.International journal of mental health systems · 2025Review
- Patient Experience of Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease: Qualitative Patient and Clinician Interviews Informing the Development of a Conceptual Model.Neurology and therapy · 2025Article
- A decision-making tool for navigating extracellular vesicle research and product development.Journal of extracellular vesicles · 2024Article
- Article
- Integrating environmental effects in the benefit-risk assessment of therapeutic products: a proposal and example for sustainable health and healthcare.Frontiers in drug safety and regulation · 2024Review
- Treatment Preference for Alzheimer's Disease: A Multicriteria Decision Analysis with Caregivers, Neurologists, and Payors.Neurology and therapy · 2023Article
- Quantitative Benefit-Risk Assessment of COVID-19 Vaccines Using the Multi-Criteria Decision Analysis.Vaccines · 2022Article
- Future directions in regulatory affairs.Frontiers in medicine · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The approval process for pharmaceuticals has always included a consideration of the trade-offs between benefits and risks. Until recently, these trade-offs have been made in panel discussions without using a decision model to explicitly consider what these trade-offs might be. Recently, the EMA and the FDA have embraced Multi-Criteria Decision Analysis (MCDA) as a methodology for making approval decisions. MCDA offers an approach for improving the quality of these decisions and, in particular, by using quantitative and qualitative data in a structured decision model to make trade-offs in a logical, transparent and auditable way. This paper will review the recent use of MCDA by the FDA and EMA and recommend its wider adoption by other National Regulatory Authorities (NRAs) and the pharmaceutical industry.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.