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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 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.

SUBMITTER: Falk Delgado A

PROVIDER: S-EPMC5569019 | biostudies-other | 2017 Aug

REPOSITORIES: biostudies-other

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

Falk Delgado Alberto A Falk Delgado Anna A

Scientific reports 20170823 1

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 pr ...[more]

PMID: 28835682

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Dataset Information

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

Publications

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

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