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

Sci Rep. 2017 Aug 23;7(1):9206. doi: 10.1038/s41598-017-09553-y.

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.

Publication types

  • Meta-Analysis

MeSH terms

  • Biomarkers
  • Cross-Sectional Studies
  • Humans
  • Medical Oncology / statistics & numerical data
  • Neoplasms / diagnosis
  • Neoplasms / epidemiology*
  • Neoplasms / therapy
  • Outcome Assessment, Health Care*
  • Randomized Controlled Trials as Topic*

Substances

  • Biomarkers