Statistical Considerations for Trials in Adjuvant Treatment of Colorectal Cancer

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The design of the best possible clinical trials of adjuvant interventions in colorectal cancer will entail the use of both time-tested and novel methods that allow efficient, reliable and patient-relevant therapeutic development. The ultimate goal of this endeavor is to safely and expeditiously bring to clinical practice novel interventions that impact patient lives. In this paper, we discuss statistical aspects and provide suggestions to optimize trial design, data collection, study implementation, and the use of predictive biomarkers and endpoints in phase 3 trials of systemic adjuvant therapy. We also discuss the issues of collaboration and patient centricity, expecting that several novel agents with activity in the (neo)adjuvant therapy of colon and rectal cancers will become available in the near future.

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“Statistical Considerations for Trials in Adjuvant Treatment of Colorectal Cancer” has been published in Cancers as part of the Special Issue Adjuvant Chemotherapy for Colorectal Cancer.

(This article belongs to the Special Issue Adjuvant Chemotherapy for Colorectal Cancer)

Received: 16 September 2020; Accepted: 17 November 2020; Published: 19 November 2020