Evidence map›Paper›PMID 34919008›Full record

ArticleCancer investigation2022

Fooled by Randomness. The Misleading Effect of Treatment Crossover in Randomized Trials of Therapies with Marginal Treatment Benefit.

Vicente Valentí, Paula Jiménez-Fonseca, Pavlos Msaouel, Ramón Salazar, Alberto Carmona-Bayonas

Abstract read
In one paragraph

Article in Cancer investigation, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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

6 citing papers in PubMed.

  1. Existing challenges in the management of cholangiocarcinoma in Spain.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
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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

5 authors.

Vicente ValentíMedical Oncology Division, Hospital Sant Pau i Santa Tecla, Tarragona, Spain.ORCID 0000-0002-2963-7713
Paula Jiménez-FonsecaHospital Universitario Central de Asturias, Oviedo, Spain.ORCID 0000-0003-4592-3813
Pavlos MsaouelGenitourinary Medical Oncology Division, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.ORCID 0000-0001-6505-8308
Ramón SalazarMedical Oncology Division, Institut Català d'Oncologia, L'Hospitalet de Llobregat, Barcelona, Spain.
Alberto Carmona-BayonasHospital General Universitario Jose M Morales Meseguer, Murcia, Spain.ORCID 0000-0002-1930-9660

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

Crossover can bias clinical outcomes of randomized clinical trials by increasing the risk of both type I (false positive) and type II (false negative) errors. To show how crossover can increase type I error, we provide computer simulation and review herein illustrative examples (iniparib, olaratumab) of recently reported RCTs that demonstrated false-positive treatment efficacy signals due to crossover. The ethical issues associated with crossover are also discussed.

Indexed as

Antibodies, MonoclonalBenzamidesBiasComputer SimulationCross-Over StudiesHumansNeoplasmsRandomized Controlled Trials as TopicResearch DesignTreatment OutcomeAntibodies, MonoclonalBenzamidesiniparibolaratumabbiasCrossoverrandomized clinical trials

Identifiers

PMID34919008
PMCPMC12289325

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.