Handbook for Clinical Trials of Imaging and Image-guided Interventions

Handbook for Clinical Trials of Imaging and Image-Guided Interventions is the first single-source, multi-disciplinary reference, based on the didactic sessions presented at the annual ‘Clinical Trials Methodology Workshop’ for radiologists, radiation oncologists and imaging scientists (sponsored by the Radiological Society of North America (RSNA)). It focuses on educating radiologists, radiation oncologists and those involved in imaging research with how to design and conduct clinical trials to evaluate imaging technology and imaging biomarkers.

The internationally renowned contributors take a broad approach, starting with principles of technology assessment, and then move into specific topics covering the clinical trials of therapy and clinical research in imaging guided interventions including radiotherapy. They discuss the use of imaging as a predictor of therapeutic response, screening trial design, and the practicalities of how to run an efficient clinical trial and good working practices. Later chapters provide a comprehensive array of quantitative methods including: an introduction to statistical considerations in study design, biostatistical analysis methods and their role in clinical imaging research, methods for quantitative imaging biomarker studies, and an introduction to cost effectiveness analysis.

Handbook for Clinical Trials of Imaging and Image-Guided Interventions will educate and prepare radiologists at all levels and in all capacities in planning and conducting clinical imaging trials.

Nancy A. Obuchowski, PhD Vice Chair for Quantitative Health Sciences, Cleveland Clinic Foundation, and Professor of Medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, USA

G. Scott Gazelle, MD, MPH, PhD, FACR Director Emeritus of the Massachusetts General Hospital Institute for Technology Assessment, Professor of Radiology at Harvard Medical School, and Professor in the Department of Health Policy and Management at the Harvard School of Public Health, USA

Contributors, vi

Chapter 1 Imaging technology assessment, 1
Pari V. Pandharipande and G. Scott Gazelle

Chapter 2 Clinical trials of therapy, 10
Sayeh Lavasani, Anthony F. Shields and Ali Mahinbakht

Chapter 3 Clinical trials of image]guided interventions including radiotherapy studies, 29
Gary S. Dorfman and Stephen M. Hahn

Chapter 4 Imaging as a predictor of therapeutic response, 57
David A. Mankoff and Anthony F. Shields

Chapter 5 Screening trials and design, 76
Janie M. Lee, Constance D. Lehman and Diana L. Miglioretti

Chapter 6 Practicalities of running a clinical trial, 91
Michael T. Lu, Elizabeth C. Adami and Udo Hoffmann

Chapter 7 Statistical issues in study design, 103
Nancy A. Obuchowski

Chapter 8 Introduction to biostatistical methods, 126
Diana L. Miglioretti, Todd A. Alonzo and Nancy A. Obuchowski

Chapter 9 Methods for studies of diagnostic tests, 147
Jeffrey D. Blume

Chapter 10 Methods for quantitative imaging biomarker studies, 170
Alicia Y. Toledano and Nancy A. Obuchowski

Chapter 11 Introduction to cost]effectiveness analysis in clinical trials, 189
Ruth C. Carlos and G. Scott Gazelle

Index, 208

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