Table_1_The Statistical Evaluation of Treatment and Outcomes in Head and Neck Squamous Cell Carcinoma Clinical Trials.DOCX

The purpose of this article is two-fold: to help statisticians confronted with the design, implementation and analysis of clinical trials and new to the field of head and neck cancer; but also to sensitize research physicians with the role, the tasks and the challenges faced by the medical statisticians. These two purposes altogether will hopefully encourage and enable fluid communication between the research physician and the medical statistician and the understanding of each other's field and concerns. In particular, the methodological challenges resulting from the heterogeneity of the head and neck cancer, the complexity of the treatments and the associated comorbidities are presented with examples borrowed from medical literature and from the practical experience of the authors in this field.

本文旨在达成双重目标：一是帮助那些刚接触头颈部肿瘤（head and neck cancer）领域、且需开展临床试验设计、实施与分析工作的统计学者；二是让研究型医师明晰医学统计学家所承担的角色、工作职责与面临的挑战。通过达成这两大目标，有望推动研究型医师与医学统计学家之间实现顺畅沟通，并增进双方对彼此领域与关切点的理解。具体而言，本文结合医学文献案例与作者在该领域的实践经验，阐述了由头颈部肿瘤异质性、治疗复杂性及其相关合并症所引发的各类方法论挑战。