Affiliations: [a] Division of Hematology and Oncology, Indiana University School of Medicine, Indianapolis, Indiana, USA | [b] Supported in part by an American Society of Clinical Oncology Career Development Award | [c] St. Francis Cancer Center, Hartford, Connecticut, USA | [d] Supported in part by a grant from the Walther Cancer Institute
Correspondence:
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Corresponding author: Kathy D. Miller, Indiana Cancer Pavilion, 535 Barnhill Dr. RT-473, Indianapolis, IN 46202, USA. Tel.: +1 317 274 0920; Fax: +1 317 274 3646; E-mail: kathmill@iupui.edu.
Abstract: All research is subject to bias that may systematically distort results. Though over 50 types of bias in analytical research have been identified and many classification schemes proposed, this review focuses on the special problem of selection bias in clinical trials. We demonstrate the systematic nature of selection bias in clinical research. We describe the common sources of selection bias in clinical trials including the (inappropriate) use of historical controls, stage migration, inclusion/exclusion criteria, the use of multiple subset analyses, and investigator bias. We then move from the general to the specific, using the recent experience of high dose chemotherapy for breast cancer as an illustrative example. Finally, we suggest means to avoid falling into the many selection bias traps that often confront clinical researchers.
DOI: 10.3233/BD-2001-14105
Journal: Breast Disease, vol. 14, no. 1, pp. 31-40, 2001
