Abstract
Radiological imaging has been used as an integrated part of modern clinical trials for patient selection, safety monitoring, and measuring treatment efficacy . Before we use quantitative measures, also called markers, derived from imaging in trials, we need to establish their scientific relevance (validity), as well as clinical utility and analytic validity. Clinical utility can be demonstrated in saving time and/or cost. Analytic validity can be demonstrated for measurement consistency over time and across participating sites. This chapter discusses two statistical applications in imaging clinical trials related to these utilities. The first example (Sect. 11.2) was motivated by whether to use imaging surrogate marker in phase II oncology trials. The second example (Sect. 11.3) was motivated by monitoring longitudinal performance of dual X-ray absorptiometry (DXA) scanner performance in pediatric trials. They were from my lecture in XV BASS on November 14, 2008, in Sylvania, Georgia, USA, which has not been published elsewhere.
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Acknowledgements
I would like to make acknowledgment of contributions of my colleagues and funding supports. The bivariate QC was a joint work by Drs. John Shepherd, Shoujun Zhao, and Bo Fan at the Department of Radiology and Biomedical Imaging, University of California, San Francisco. That part of work was supported by a grant from CDC 200-2005-11219 (PI: Dr. Shepherd). The first part of utility of surrogate endpoints was supported by a grant from NIH R01 EB004079-01 (PI: Lu). The work was performed when author worked at the University of California, San Francisco.
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Lu, Y. (2018). Statistical Considerations for Quantitative Imaging Measures in Clinical Trials. In: Peace, K., Chen, DG., Menon, S. (eds) Biopharmaceutical Applied Statistics Symposium . ICSA Book Series in Statistics. Springer, Singapore. https://doi.org/10.1007/978-981-10-7820-0_11
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DOI: https://doi.org/10.1007/978-981-10-7820-0_11
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