Evidence map›Paper›PMID 34751763›Full record

ArticleJAMA network open2021

Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval.

Joshua D Wallach, Audrey D Zhang, Joshua J Skydel, Victoria L Bartlett, Sanket S Dhruva, Nilay D Shah, Joseph S Ross

Abstract readEvaluation Study
In one paragraph

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 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Article
  6. 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 · 2024
    Review
  7. Review
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. 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 · 2023
    Article
  15. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Joshua D WallachDepartment of Environmental Health Sciences, Yale School of Public Health, New Haven, Connecticut.
Audrey D ZhangDuke University Health System, Durham, North Carolina.
Joshua J SkydelDartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
Victoria L BartlettYale School of Medicine, New Haven, Connecticut.
Sanket S DhruvaSection of Cardiology, San Francisco Veterans Affairs Health Care System, San Francisco, California.
Nilay D ShahDivision of Health Care Policy and Research, Mayo Clinic, Rochester, Minnesota.
Joseph S RossSection of General Internal Medicine, Department of Internal Medicine, Yale School of Medicine, New Haven, Connecticut.

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Short-Term Reserch Training: Students in Health SchoolsT35HL007649 · NHLBI · YALE UNIVERSITY · PI Sarwat I Chaudhry, Erica L Herzog · 1987 to 2026
$5.7M
Identifying Patient Subgroups That Are Most Likely To Benefit From Medications Used To Treat Alcohol Use DisorderK01AA028258 · NIAAA · YALE UNIVERSITY · PI WALLACH, JOSHUA DAVID · 2021 to 2025
$892k
NCATS NIH HHS UL1 TR001863NHLBI NIH HHS T35 HL007649NIAAA NIH HHS K01 AA028258
6 · The paper itself

Abstract

PubMed holds no abstract for this paper.

Indexed as

Cross-Sectional StudiesData ScienceDrug ApprovalFeasibility StudiesHumansPragmatic Clinical Trials as TopicProduct Surveillance, PostmarketingUnited StatesUnited States Food and Drug Administration

Identifiers

PMID34751763
PMCPMC8579227

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.