ReviewTherapeutic advances in drug safety2019
Benefit-risk evaluation: the past, present and future.
Review in Therapeutic advances in drug safety, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 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
21 citing papers in PubMed.
- Incorporating Patient Perspectives into Structured Benefit-Risk Assessment: A Drug Development Framework Recommendation.Therapeutic innovation & regulatory science · 2026Review
- Challenges in Conducting Quantitative Patient-Centered Benefit-Risk Assessments: A Case Study in Ph + ALL with Immature Efficacy Data.Therapeutic innovation & regulatory science · 2026Article
- Discrete Choice Experiment (DCE) as a Tool to Elicit Patient Preferences in a Complex Benefit-Risk Evaluation: A Case Study.Clinical drug investigation · 2026Article
- Methodological comparisons for benefit-risk assessment in complex decision-making: applications and insights from a case study.Frontiers in drug safety and regulation · 2026Article
- Identification and Description of Regulatory and Health Technology Assessment Agencies' Guidance Related to Patient Experience Data in North America, Europe, and Asia Pacific.Therapeutic innovation & regulatory science · 2025Article
- New Serious Safety Warnings for Targeted Anticancer Agents After Their Initial FDA Approval.Cancers · 2025Article
- Competing Benefits and Competing Hazards: The Benefit to Harm Balance in Individual Patients in Rational Therapeutics.Drug safety · 2024Article
- Use of Drug Sensitisers to Improve Therapeutic Index in Cancer.Pharmaceutics · 2024Review
- Methodological guidelines and publications of benefit-risk assessment for health technology assessment: a scoping review.BMJ open · 2024Article
- Targeted Treatment of Schizophrenia Symptoms as They Manifest, or Continuous Treatment to Reduce the Risk of Psychosis Recurrence.Schizophrenia bulletin · 2024Article
- Methodological guidelines and publications of benefit-risk assessment for health technology assessment: a scoping review protocol.BMJ open · 2023Article
- Appropriate design and reporting of superiority, equivalence and non-inferiority clinical trials incorporating a benefit-risk assessment: the BRAINS study including expert workshop.Health technology assessment (Winchester, England) · 2023Article
- A Structured Benefit-Risk Assessment Operating Model for Investigational Medicinal Products in the Pharmaceutical Industry.Therapeutic innovation & regulatory science · 2023Review
- Point estimation for adaptive trial designs II: Practical considerations and guidance.Statistics in medicine · 2023Review
- An Innovative Tool for Evidence-Based, Personalized Treatment Trials in Mucopolysaccharidosis.Pharmaceutics · 2023Article
- Quantitative Benefit-Risk Assessment of COVID-19 Vaccines Using the Multi-Criteria Decision Analysis.Vaccines · 2022Article
- Global Landscape of Benefit-Risk Considerations for Medicinal Products: Current State and Future Directions.Pharmaceutical medicine · 2022Article
- Comparative Benefit-Risk Assessment for Lidocaine 700 mg Medicated Plaster and Pregabalin in Peripheral Neuropathic Pain Following a Structured Framework Approach.Pain and therapy · 2022Article
- Patient Preferences of Low-Dose Aspirin for Cardiovascular Disease and Colorectal Cancer Prevention in Italy: A Latent Class Analysis.The patient · 2021Article
- Multi-Criteria Decision Analysis for Benefit-Risk Analysis by National Regulatory Authorities.Frontiers in medicine · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In the last two decades there has been a shift in the approach to evaluating the benefit-risk (BR) profiles of medicinal products from an unstructured, subjective, and inconsistent, to a more structured and objective, process. This article describes that shift from a historical perspective; the past, the present, and the future, and highlights key events that played critical roles in changing the field.
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.