Evidence map›Paper›PMID 34196501›Full record

ArticleEthics & human research2021

The Inevitability and Ethics of Inaccurate Screening in Clinical Trials: A Call for Research and Guidance.

David Wendler

Abstract read
In one paragraph

Article in Ethics & human research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

David WendlerHeads the Section on Research Ethics at the Clinical Center at the National Institutes of Health.

Funding

Research and clinical care without informed consentZIACL010537 · CLC · CLINICAL CENTER · PI WENDLER, DAVID S · 2014 to 2025
$0k
Intramural NIH HHS Z99 CL999999
6 · The paper itself

Abstract

Accurate screening of potential research participants is vital to ensuring the scientific, regulatory, and ethical appropriateness of clinical trials. Yet there are no definitive screening tests for many conditions, and many screening tests, even when implemented correctly, yield some inaccurate results. Sponsors, researchers, and review committees thus routinely face the question of when it is acceptable to approve and conduct clinical trials that rely on screening measures that are known to exclude some eligible individuals and to include some ineligible ones. This article calls attention to and proposes preliminary guidance to address this important issue.

Indexed as

Ethics Committees, ResearchInformed ConsentEthical ReviewEthics, ResearchHumansResearch Personnelclinical trialseligibilityexclusionhuman research ethicsinclusionpregnant women in researchreview committeesscreeningvalidity

Identifiers

PMID34196501
PMCPMC10107694

What OpenQuestion holds

Textmetadata
LicenceTDM
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.