Evidence map›Paper›PMID 32538347›Full record

ArticleHealthcare policy = Politiques de sante2020

Commentary: Expedited Regulatory Review of Low-Value Drugs.

Jonathan J Darrow, Reed F Beall

Abstract read
In one paragraph

Article in Healthcare policy = Politiques de sante, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

2 authors.

Jonathan J DarrowAssistant Professor, Program on Regulation, Therapeutics and Law (PORTAL), Brigham and Women's Hospital and Harvard Medical School, Boston, MA.
Reed F BeallAssistant Professor, Community Health Sciences and O'Brien Institute for Public Health, Cumming School of Medicine, University of Calgary, Calgary, AB.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Lexchin has criticized Health Canada's recently published draft guidance on accelerated drug review, expressing concern over agency conflicts of interest and observing that priority review and notice of compliance with conditions correlate poorly with therapeutic benefit. Although agency operations may be imperfect, perhaps the most important finding of Lexchin's research is that only 11% of newly approved drugs provide meaningful benefit over standard treatments. To improve the expedited review process in light of these findings, we suggest eliminating user fees and fully funding the review process with public monies, reserving the use of expedited approval pathways for when preliminary measures of benefit are so large that traditional approval thresholds can be met earlier in the clinical trial process, improving labelling to quantitatively communicate drug benefits and risks, and avoiding the use of titles such as "priority" review, which could imply a magnitude of clinical superiority that has not been established.

Indexed as

CanadaDrug ApprovalGovernment RegulationHumansSafety-Based Drug WithdrawalsTime Factors

Identifiers

PMID32538347
PMCPMC7294442

What OpenQuestion holds

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LicenceCC BY-NC
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.