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JNCI Journal of the National Cancer Institute 2003 95(18):1351-1352; doi:10.1093/jnci/djg070
© 2003 by Oxford University Press
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© 2003 Oxford University Press

EDITORIAL

Selection Bias, Phase II Trials, and the FDA Accelerated Approval Process

Stephen L. George

Correspondence to: Stephen L. George, PhD, Duke University Medical Center, Cancer Center Biostatistics, Box 3958, Durham NC 27710 (e-mail: stephen.george@duke.edu).

The first 10% of the full text of this article appears below.

Several observational studies have found that the distance traveled from a patient’s home to the treatment center is an important prognostic variable. In this issue of the Journal, Lamont et al. (1) investigated this phenomenon for clinical trials at a specialized cancer treatment center and reported that patients with head and neck cancer enrolled on phase II clinical trials experienced better survival the further they lived from the treatment center. This finding could not be explained away by adjustment for other observable demographic, medical, or socioeconomic factors (e.g., age, stage of disease, performance status, income level) that are known to influence outcomes. We are . . . [Full Text of this Article]


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