ArticleJAMA network open2021
Comparison of Duration of Postapproval vs Pivotal Trials for Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval, 2009-2018.
Article in JAMA network open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 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
14 citing papers in PubMed.
- Estimating the Potential Benefits of Confirmatory Trials for Drugs with Accelerated Approval: A Comprehensive Value of Information Framework.PharmacoEconomics · 2023Trial
- Industry promotion of oncology drugs with accelerated approval that failed confirmatory trials.Journal of the National Cancer Institute · 2026Article
- Postmarket Safety Actions for Novel Oncology Drugs Granted FDA's Accelerated Approval.JAMA network open · 2026Article
- Flexibility over rigor: stakeholder acceptance of the limitations of confirmatory studies following accelerated approval.Health affairs scholar · 2025Article
- Accelerating the approval of mpox vaccines based on lessons learnt from COVID-19 vaccines through the lens of regulatory science.BMJ global health · 2025Review
- Physician-Patient Communication about Novel Drugs and High-Risk Medical Devices.Medical decision making : an international journal of the Society for Medical Decision Making · 2025Article
- Article
- Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy.The European journal of health economics : HEPAC : health economics in prevention and care · 2024Review
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- Article
- Timing of Confirmatory Trials for Drugs Granted Accelerated Approval Based on Surrogate Measures From 2012 to 2021.JAMA health forum · 2023Article
- Aducanumab, Accelerated Approvals & the Agency: Why the FDA Needs Structural Reform.The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2023Article
- Use of US Food and Drug Administration Expedited Drug Development and Review Programs by Orphan and Nonorphan Novel Drugs Approved From 2008 to 2021.JAMA network open · 2022Article
- Spending by the Centers for Medicare & Medicaid Services Before and After Confirmation of Benefit for Drugs Granted US Food and Drug Administration Accelerated Approval, 2012 to 2017.JAMA health forum · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
Abstract
PubMed holds no abstract for this paper.
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.