ReviewDialogues in clinical neuroscience2011
Assessing the benefit: risk ratio of a drug--randomized and naturalistic evidence.
Review in Dialogues in clinical neuroscience, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers, 2 of them syntheses that pooled it.
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, 2 syntheses or guidelines pooled it.
- Assessing Patient Risk, Benefit, and Outcomes in Drug Development: A Decade of Lenvatinib Clinical Trials: A Systematic Review.Targeted oncology · 2024Pooled it
- Does Internet-based guided-self-help for depression cause harm? An individual participant data meta-analysis on deterioration rates and its moderators in randomized controlled trials.Psychological medicine · 2016Pooled it
- Combining Plant Bioactives With Antibiotics for Enhanced Antibiofilm Activity Against UropathogenicAdvances in pharmacological and pharmaceutical sciences · 2025Article
- Pharmacovigilance and bioethics: the importance of a neglected relationship.Frontiers in drug safety and regulation · 2025Review
- Pharmacovigilance in Vaccines: Importance, Main Aspects, Perspectives, and Challenges-A Narrative Review.Pharmaceuticals (Basel, Switzerland) · 2024Review
- Methodological guidelines and publications of benefit-risk assessment for health technology assessment: a scoping review.BMJ open · 2024Article
- Drug Repurposing Using FDA Adverse Event Reporting System (FAERS) Database.Current drug targets · 2024Review
- Knowledge of recommended antibiotic treatments for community-acquired infections in general medical practice: a cross-sectional study in Occitanie region, France.Scientific reports · 2023Article
- Drug Safety in Episodic Migraine Management in Adults Part 1: Acute Treatments.Current pain and headache reports · 2022Review
- Patient-based benefit-risk assessment of medicines: development, refinement, and validation of a content search strategy to retrieve relevant studies.Journal of the Medical Library Association : JMLA · 2022Article
- Dynamics of Patient-Based Benefit-Risk Assessment of Medicines in Chronic Diseases: A Systematic Review.Patient preference and adherence · 2022Review
- Risk Management Framework for Nano-Biomaterials Used in Medical Devices and Advanced Therapy Medicinal Products.Materials (Basel, Switzerland) · 2020Article
- Precision Dosing Priority Criteria: Drug, Disease, and Patient Population Variables.Frontiers in pharmacology · 2020Review
- Multi-Criteria Decision Analysis to Develop an Efficacy-Safety Profile of Parenteral Analgesics Used in the Treatment of Postoperative Pain.Journal of pain research · 2020Article
- Medication Risk Management.Innovations in pharmacy · 2019Article
- Assessing patients' acceptance of their medication to reveal unmet needs: results from a large multi-diseases study using a patient online community.Health and quality of life outcomes · 2018Observational
- Causality and preventability assessment of adverse drug events of antibiotics among inpatients having different lengths of hospital stay: a multicenter, cross-sectional study in Lahore, Pakistan.BMC pharmacology & toxicology · 2018Observational
- Direct oral anticoagulants for extended thromboprophylaxis in medically ill patients: meta-analysis and risk/benefit assessment.Journal of blood medicine · 2018Article
- Dilemmas of the causality assessment tools in the diagnosis of adverse drug reactions.Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society · 2016Review
- Integration of PKPD relationships into benefit-risk analysis.British journal of clinical pharmacology · 2015Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Randomized evidence from clinical trials and naturalistic evidence collected from pharmacoepidemiology and pharmacovigilance activities both contribute to the initial and continuous assessment of the benefits and risks of a drug, ie, the balance between therapeutic efficacy and safety risks. Benefit-risk assessment (BRA) mainly relies on a qualitative assessment of quantitative data. Current attempts to quantify BRA are reviewed and discussed, along with the expectations of regulatory authorities such as the Food and Drug Administration and the European Medicines Agency. No method provides a fully satisfactory solution regarding BRA, because it is difficult to reduce its multidimensional aspect to simple metrics, in a context where other therapeutic alternatives play a role. Consistency and transparency are key in this assessment, which is performed throughout the whole drug life cycle. BRA is mainly based on randomized clinical studies during clinical development, and it is continued and consolidated by naturalistic data once the drug is on the market.
Indexed as
Identifiers
21842615PMC3181998What 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.