Titlebook: Medical Imaging in Clinical Trials; Colin G. Miller,Joel Krasnow,Lawrence H. Schwartz Book 2014 Springer-Verlag London 2014 Ultrasonograph

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The Metrics and New Imaging Marker Qualification in Medical Imaging Modalitiestic intervention. There are eight key metrics when evaluating a biomarker or imaging technique which has to be put into context with the key use of the system. This chapter will describe these key metrics in this context with particular emphasis of the use in clinical trials.

GOAT

Radiation Risks and Dosimetry Assessmentnning stage and that the radiation risks are adequately explained as part of the informed consent process. It outlines the steps to take to assess the radiation dose, taking into account the potential variation between participating centres. It examines the risks associated with radiation exposure a

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Imaging Review Charters and Operational Considerationsre are FDA guidelines (albeit in draft at the time of writing and presented verbatim in Appendix 1 of this book), which detail the requirements and contents for the Imaging Review Charter (IRC). This chapter provides the historical perspective for these guidelines and details the contents that have

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Defining the Radiological Blinded Read and Adjudicationteam of radiologists and or physicians. There are three major kinds of blinded read: eligibility, safety, and efficacy, of which each of these is managed in a different manner. This chapter presents the various methodologies that are employed in blinded reads across phases of trials and between diff

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Monitoring Responses to Therapy in Oncology trials. The fate of a new drug should not be wrongfully determined because of imprecise assessment methods used in the clinical trial. Therefore, it is crucial to select the most appropriate response assessment method, which considers the mechanisms of interactions between drugs and cancers as well

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