ReviewNature reviews. Drug discovery2013
The risks of risk aversion in drug regulation.
Review in Nature reviews. Drug discovery, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 1 of them a synthesis 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
39 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Opportunities and challenges for the inclusion of patient preferences in the medical product life cycle: a systematic review.BMC medical informatics and decision making · 2019Pooled it
- Ethics as if Your Life Depended on It.Journal of empirical research on human research ethics : JERHRE · 2026Article
- Design, simulate, refine: simulation-guided clinical trials for accelerated drug development.Nature reviews. Drug discovery · 2026Review
- Analytic Misjudgment of Drug Safety Evidence and Causality: From the Prosecutor's Fallacy and Simpson's Paradox to Artificial Intelligence.Drug safety · 2026Review
- Responses to Commentaries on "Ethics as if Your Life Depended on It".Journal of empirical research on human research ethics : JERHRE · 2026Article
- Trends in EU regulatory assessment of oncology medicines.ESMO open · 2026Article
- Comparison of commercial 1Tx32Rx vs. 8Tx32Rx head coils for routine 7T neuroimaging.Frontiers in neuroimaging · 2026Article
- Evaluating Risk and Benefit Sensitivity for Cognitive Treatments.Journal of cognitive enhancement : towards the integration of theory and practice · 2025Article
- Measuring the multidimensional reputation of a medicines regulatory agency: development and validation of a public-oriented scale.Frontiers in medicine · 2025Article
- Technology Assessment vs. Technology Appraisal-How to Strengthen the Science/Value Dichotomy with EU HTA?Journal of market access & health policy · 2024Article
- Expediting treatments in the 21st century: orphan drugs and accelerated approvals.Orphanet journal of rare diseases · 2024Article
- Achieving synchrony: bridging the gap between pharmaceutical companies and regulators on safety labeling updates.Frontiers in drug safety and regulation · 2024Article
- Exploring the scientific underpinnings of investigating safety signals: analytical insights in deciphering drug safety evidence.Frontiers in drug safety and regulation · 2024Article
- Uncertainty management in regulatory and health technology assessment decision-making on drugs: guidance of the HTAi-DIA Working Group.International journal of technology assessment in health care · 2023Review
- Regulatory Evaluation of Biosimilars: Refinement of Principles Based on the Scientific Evidence and Clinical Experience.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2022Review
- Regulatory science: Regulation is too important to leave it to the regulators.British journal of clinical pharmacology · 2020Article
- Transforming vaccine development.Seminars in immunology · 2020Review
- An Efficient Development Paradigm for Biosimilars.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2019Article
- Are There Different Evidence Thresholds for Genomic Versus Clinical Precision Medicine? A Value of Information-Based Framework Applied to Antiplatelet Drug Therapy.Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research · 2019Article
- Patient-Focused Drug Development Methods for Benefit-Risk Assessments: A Case Study Using a Discrete Choice Experiment for Antiepileptic Drugs.Clinical pharmacology and therapeutics · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Drugs are approved by regulatory agencies on the basis of their assessment of whether the available evidence indicates that the benefits of the drug outweigh its risks. In recent years, regulatory agencies have been criticized both for being overly tolerant of risks or being excessively risk-averse, which reflects the challenge in determining an appropriate balance between benefit and risk with the limited data that is typically available before drug approval. The negative consequences of regulatory tolerance in allowing drugs onto the market that turn out to be unsafe are obvious, but the potential for adverse effects on public health owing to the absence of new drugs because of regulatory risk-aversion is less apparent. Here, we discuss the consequences of regulatory risk-aversion for public health and suggest what might be done to best align acceptance of risk and uncertainty by regulators with the interests of public health.
Indexed as
Identifiers
24232377What 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.