ArticleJAMA2023
Association Between Preapproval Confirmatory Trial Initiation and Conversion to Traditional Approval or Withdrawal in the FDA Accelerated Approval Pathway.
Article in JAMA, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 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
15 citing papers in PubMed, 1 synthesis or guideline pooled it.
- National Comprehensive Cancer Network Guideline Recommendations of Cancer Drugs With Accelerated Approval.JAMA network open · 2023Guideline
- Japan's Conditional/Time-Limited Early Approval System in Regenerative Medicine: A Case Study of Rise and Falls of Autologous Skeletal Myoblast Sheets.Clinical pharmacology and therapeutics · 2025Article
- US FDA-accelerated approvals and subsequent withdrawals: influence on Japanese clinical oncology practice guidelines.Investigational new drugs · 2025Article
- Factors in Time to Full Approval or Withdrawal for Anticancer Medicines Granted Accelerated Approval by the FDA.JAMA network open · 2025Article
- Characteristics, clinical evidence and implementation effects of conditional approvals for drugs in China, a pooled analysis from 2020 to 2023.Frontiers in pharmacology · 2025Article
- Article
- Early access disparities in innovative therapies across the US, EU, China, and Japan.Frontiers in medicine · 2025Article
- The high costs of anticancer therapies in the USA: challenges, opportunities and progress.Nature reviews. Clinical oncology · 2024Review
- Expediting treatments in the 21st century: orphan drugs and accelerated approvals.Orphanet journal of rare diseases · 2024Article
- Progress and challenges of confirmatory trials for cancer drugs granted conditional approval in China.The Lancet regional health. Western Pacific · 2024Article
- Analysis of post-marketing requirements for oncology drug conditional approvals in the United States and China.Heliyon · 2024Article
- Continued cancer drug approvals in Japan and Europe after market withdrawal in the United States: A comparative study of accelerated approvals.Clinical and translational science · 2024Article
- Regulatory histories of recently withdrawn ovarian cancer treatment indications of 3 PARP inhibitors in the US and Europe: lessons for the accelerated approval pathway.Journal of pharmaceutical policy and practice · 2024Article
- Improving Food and Drug Administration-Centers for Medicare and Medicaid Services Coordination for Drugs Granted Accelerated Approval.The Milbank quarterly · 2023Article
- Evidence of pre-approval clinical trial supporting the granted conditional approval for novel cancer drugs in China between 2015 and 2022.EClinicalMedicine · 2023Article
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.
Funding
No grant is acknowledged in the PubMed record.
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.