Evidence map›Paper›PMID 33115456›Full record

ArticleBMC medical ethics2020

Redundant trials can be prevented, if the EU clinical trial regulation is applied duly.

Daria Kim, Joerg Hasford

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC medical ethics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
–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

11 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  4. Review
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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.

Daria KimResearch Fellow, Max Planck Institute for Innovation and Competition, Marstallplatz 1, 81545, Munich, Germany. daria.kim@ip.mpg.de.ORCID 0000-0002-1422-9522
Joerg HasfordLudwig-Maximilians-University of Munich, The Institute for Medical Information Processing, Biometry, and Epidemiology, and Chairman of the Permanent Working Party of Research Ethics Committees in Germany, Scharnitzerstaße 7, 82166, Gräfelfing, Germany.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The problem of wasteful clinical trials has been debated relentlessly in the medical community. To a significant extent, it is attributed to redundant trials - studies that are carried out to address questions, which can be answered satisfactorily on the basis of existing knowledge and accessible evidence from prior research. This article presents the first evaluation of the potential of the EU Clinical Trials Regulation 536/2014, which entered into force in 2014 but is expected to become applicable at the end of 2021, to prevent such trials. Having reviewed provisions related to the trial authorisation, we propose how certain regulatory requirements for the assessment of trial applications can and should be interpreted and applied by national research ethics committees and other relevant authorities in order to avoid redundant trials and, most importantly, preclude the unnecessary recruitment of trial participants and their unjustified exposure to health risks.

Indexed as

Ethics Committees, ResearchHumansClinical trialsEU clinical trials regulationResearch ethicsResearch ethics committeesResearch redundancySystematic reviewTrial authorisationTrial methodology

Identifiers

PMID33115456
PMCPMC7592564

What OpenQuestion holds

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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.