• Jpn. J. Clin. Oncol. · Apr 2015

    Review

    Methodological issues in observational studies and non-randomized controlled trials in oncology in the era of big data.

    • Shiro Tanaka, Sachiko Tanaka, and Koji Kawakami.
    • Department of Pharmacoepidemiology, Graduate School of Medicine and Public Health, Kyoto University, Kyoto, Japan tanaka.shiro.8n@kyoto-u.ac.jp.
    • Jpn. J. Clin. Oncol. 2015 Apr 1;45(4):323-7.

    AbstractNon-randomized controlled trials, cohort studies and database studies are appealing study designs when there are urgent needs for safety data, outcomes of interest are rare, generalizability is a matter of concern, or randomization is not feasible. This paper reviews four typical case studies from methodological viewpoints and clarifies how to minimize bias in observational studies in oncology. In summary, researchers planning observational studies should be cautious of selection of appropriate databases, validity of algorithms for identifying outcomes, comparison with incident users or self-control, rigorous collection of information on potential confounders and reporting details of subject selection. Further, a careful study protocol and statistical analysis plan are also necessary.© The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

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