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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
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, 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.

Place, publisher, year, edition, pages
2017. Vol. 7, no 1, article id 9206
National Category
Medical and Health Sciences
Identifiers
URN: urn:nbn:se:uu:diva-334000DOI: 10.1038/s41598-017-09553-yPubMedID: 28835682OAI: oai:DiVA.org:uu-334000DiVA, id: diva2:1158461
Available from: 2017-11-20 Created: 2017-11-20 Last updated: 2017-11-20

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