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Review
. 2019 Jul 12:9:634.
doi: 10.3389/fonc.2019.00634. eCollection 2019.

The Statistical Evaluation of Treatment and Outcomes in Head and Neck Squamous Cell Carcinoma Clinical Trials

Affiliations
Review

The Statistical Evaluation of Treatment and Outcomes in Head and Neck Squamous Cell Carcinoma Clinical Trials

Catherine Fortpied et al. Front Oncol. .

Abstract

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.

Keywords: clinical trial; comorbidities; endpoint; head and neck cancer; patient population; statistical analysis; statistical design; treatment.

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References

    1. EEC note for guidance: good clinical practice for trials on medicinal products in the European Community CPMP working party on efficacy of medicinal products. Pharmacol Toxicol. (1990) 67:361–72. 10.1111/j.1600-0773.1990.tb00847.x - DOI - PubMed
    1. Silberzahn R, Uhlmann EL, Martin DP, Anselmi P, Aust F, Awtrey E, et al. Many analysts, one data set: making transparent how variations in analytic choices affect results. Adv Methods Pract Psychol Sci. (2018) 1:337–56. 10.1177/2515245917747646 - DOI
    1. ICH ICH E9 guidelines: statistical principles for clinical trials. Fed Regist. (1998) 63:49583–98. - PubMed
    1. Consort- Download the CONSORT 2010 Publications Available online at: http://www.consort-statement.org/downloads/consort-statement (accessed April 24, 2019).
    1. International council for harmonisation of technical requirements for pharmaceuticals for human use (ICH) ICH harmonised guideline. Integrated addendum to ich e6(r1): guideline for good clinical practice e6(r2) (2016).

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