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Outcome switching in randomized controlled oncology trials reporting on surrogate endpoints: a cross-sectional analysis
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Surgical Sciences, Plastic Surgery.ORCID iD: 0000-0001-9107-5814
Clinical Neuroscience, Karolinska Institute, Stockholm, Sweden; Department of Neuroradiology, Karolinska University Hospital, Stockholm, Sweden.
2017 (English)In: Scientific Reports, ISSN 2045-2322, E-ISSN 2045-2322, Vol. 7, no 1, article id 9206Article in journal (Refereed) Published
Abstract [en]

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, pā€‰=ā€‰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, pā€‰=ā€‰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.

Place, publisher, year, edition, pages
2017. Vol. 7, no 1, article id 9206
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Cancer and Oncology
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URN: urn:nbn:se:uu:diva-334000DOI: 10.1038/s41598-017-09553-yISI: 000408428400007PubMedID: 28835682OAI: oai:DiVA.org:uu-334000DiVA, id: diva2:1158461
Available from: 2017-11-20 Created: 2017-11-20 Last updated: 2018-09-03Bibliographically approved

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