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Beyond Correlations, Sensitivities, and Specificities: A Roadmap for Demonstrating Utility of Advanced Imaging in Oncology Treatment and Clinical Trial Design.

Abstract：

:Despite the widespread belief that advanced imaging should be very helpful in guiding oncology treatment decision and improving efficiency and success rates in treatment clinical trials, its acceptance has been slow. Part of this is likely attributable to gaps in study design and statistical methodology for these imaging studies. Also, results supporting the performance of the imaging in these roles have largely been insufficient to justify their use within the design of a clinical trial or in treatment decision making. Statistically significant correlations between the imaging results and clinical outcomes are often incorrectly taken as evidence of adequate performance. Assessments of whether the imaging can outperform standard techniques or meaningfully supplement them are also frequently neglected. This paper provides guidance on study designs and statistical analyses for evaluating the performance of advanced imaging in the various roles in treatment decision guidance and clinical trial conduct. Relevant methodology from the imaging literature is reviewed; gaps in the literature are addressed using related concepts from the more extensive genomic and in vitro biomarker literature.

journal_name

Acad Radiol

journal_title

Academic radiology

authors

Huang EP,Lin FI,Shankar LK

doi

10.1016/j.acra.2017.03.002

subject

Has Abstract

pub_date

2017-08-01 00:00:00

pages

1036-1049

issue

8

eissn

1076-6332

issn

1878-4046

pii

S1076-6332(17)30120-4

journal_volume

24

pub_type

杂志文章,评审

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