Outcome switching in randomized controlled oncology trials reporting on surrogate endpoints: a cross-sectional analysis

Abstract Inconsistent reporting of clinical trials is well-known in the literature. Despite this, factors associated with poor practice such as outcome switching in clinical trials are poorly understood. We performed a cross-sectional analysis to evaluate the prevalence of, and the factors associate...

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Autores principales:	Alberto Falk Delgado, Anna Falk Delgado
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2017
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/7af1641f304948d4923b46e71ded6888
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spelling	oai:doaj.org-article:7af1641f304948d4923b46e71ded68882021-12-02T16:07:59ZOutcome switching in randomized controlled oncology trials reporting on surrogate endpoints: a cross-sectional analysis10.1038/s41598-017-09553-y2045-2322https://doaj.org/article/7af1641f304948d4923b46e71ded68882017-08-01T00:00:00Zhttps://doi.org/10.1038/s41598-017-09553-yhttps://doaj.org/toc/2045-2322Abstract Inconsistent reporting of clinical trials is well-known in the literature. Despite this, factors associated with poor practice such as outcome switching in clinical trials are poorly understood. We performed a cross-sectional analysis to evaluate the prevalence of, and the factors associated with outcome switching. PubMed and Embase were searched for pharmaceutical randomized controlled trials (RCTs) in oncology reporting on a surrogate primary outcome published in 2015. Outcome switching was present in 18% (39/216). First-author male sex was significantly more likely associated with outcome switching compared to female sex with an OR of 3.05 (95% CI 1.07–8.64, p = 0.04) after multivariable adjustment. For-profit funded RCTs were less likely associated with outcome switching compared to non-profit funded research with an OR of 0.22 (95% CI 0.07–0.74, p = 0.01). First author male sex was more likely associated with outcome switching compared to female sex in drug oncology RCTs reporting on a primary surrogate endpoint. For-profit funded research was less likely associated with outcome switching compared to research funded by non-profit organizations. Furthermore, 18 percent of drug oncology trials reporting on a surrogate endpoint could have a higher risk of false positive results due to primary outcome switching.Alberto Falk DelgadoAnna Falk DelgadoNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 7, Iss 1, Pp 1-7 (2017)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Alberto Falk Delgado Anna Falk Delgado Outcome switching in randomized controlled oncology trials reporting on surrogate endpoints: a cross-sectional analysis
description	Abstract Inconsistent reporting of clinical trials is well-known in the literature. Despite this, factors associated with poor practice such as outcome switching in clinical trials are poorly understood. We performed a cross-sectional analysis to evaluate the prevalence of, and the factors associated with outcome switching. PubMed and Embase were searched for pharmaceutical randomized controlled trials (RCTs) in oncology reporting on a surrogate primary outcome published in 2015. Outcome switching was present in 18% (39/216). First-author male sex was significantly more likely associated with outcome switching compared to female sex with an OR of 3.05 (95% CI 1.07–8.64, p = 0.04) after multivariable adjustment. For-profit funded RCTs were less likely associated with outcome switching compared to non-profit funded research with an OR of 0.22 (95% CI 0.07–0.74, p = 0.01). First author male sex was more likely associated with outcome switching compared to female sex in drug oncology RCTs reporting on a primary surrogate endpoint. For-profit funded research was less likely associated with outcome switching compared to research funded by non-profit organizations. Furthermore, 18 percent of drug oncology trials reporting on a surrogate endpoint could have a higher risk of false positive results due to primary outcome switching.
format	article
author	Alberto Falk Delgado Anna Falk Delgado
author_facet	Alberto Falk Delgado Anna Falk Delgado
author_sort	Alberto Falk Delgado
title	Outcome switching in randomized controlled oncology trials reporting on surrogate endpoints: a cross-sectional analysis
title_short	Outcome switching in randomized controlled oncology trials reporting on surrogate endpoints: a cross-sectional analysis
title_full	Outcome switching in randomized controlled oncology trials reporting on surrogate endpoints: a cross-sectional analysis
title_fullStr	Outcome switching in randomized controlled oncology trials reporting on surrogate endpoints: a cross-sectional analysis
title_full_unstemmed	Outcome switching in randomized controlled oncology trials reporting on surrogate endpoints: a cross-sectional analysis
title_sort	outcome switching in randomized controlled oncology trials reporting on surrogate endpoints: a cross-sectional analysis
publisher	Nature Portfolio
publishDate	2017
url	https://doaj.org/article/7af1641f304948d4923b46e71ded6888
work_keys_str_mv	AT albertofalkdelgado outcomeswitchinginrandomizedcontrolledoncologytrialsreportingonsurrogateendpointsacrosssectionalanalysis AT annafalkdelgado outcomeswitchinginrandomizedcontrolledoncologytrialsreportingonsurrogateendpointsacrosssectionalanalysis
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Outcome switching in randomized controlled oncology trials reporting on surrogate endpoints: a cross-sectional analysis

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