Evidence map›Paper›PMID 33810203›Full record

ArticleCancers2021

Unintended Regulatory Caused Early Death-A Difficult Endpoint in Cancer Patient Care and Treatment.

Wolfgang E Berdel

Abstract read
In one paragraph

Article in Cancers, 2021. 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

1 author.

Wolfgang E BerdelDepartment of Medicine A (Hematology, Hemostaseology, Oncology, Pneumology), University Hospital of Muenster, D-48149 Muenster, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The pharmacological armory against cancer has been growing, with many new drugs approved. The Good Clinical Practice (GCP)-based Clinical Trials Directive was adopted in the EU in 2001, with the important objectives of achieving better patient safety and improved quality of clinical trial conduct. However, clinical experience with the implementation of the regulation raises the question as to whether aspects of this regulatory framework can cause harm to some patients. This question also arises in daily clinical cancer patient care when the time between the publication of pivotal study results and their approval, and details of post-approval regulations, are scrutinized. Clinical observations, provocatively summarized as "unintended regulatory caused early death", are discussed.

Indexed as

drug approval and availabilityGood Clinical Practice Guidelines (GCP)patient safetyregulatory time frames

Identifiers

PMID33810203
PMCPMC8005202

What OpenQuestion holds

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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.