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Japanese Journal of Clinical Oncology 32:1-2 (2002)
© 2002 Foundation for Promotion of Cancer Research

Editorial

Data Handling in Cancer Clinical Trials—How We Can Minimize Potential Biases

Junichi Sakamoto1 and Satoshi Teramukai2

1Department of Epidemiological and Clinical Research Information Management, Kyoto University Graduate School of Medicine, Kyoto and 2Biomedical Information Department, Amgen Ltd, Tokyo, Japan

Cancer clinical trials typically have some ‘hard’ endpoints such as death, disease relapse or progression corresponding to scientific objectives of the trial. Hard endpoints are defined as clinical landmarks that are well defined in the study protocol, definitive with respect to the disease process and require no subjectivity (1). Is this definition always acceptable?

Suppose there is no ‘lost to follow-up’ in long-term cancer clinical studies. If death from cancer is a study endpoint, it always has been and still is controversial whether . . . [Full Text of this Article]

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