Handbook for clinical trials of imaging and image-guided interventions. ([2016])

• Record Type: Book
• Further Information: Note: Edited by Nancy A. Obuchowski and G. Scott Gazelle.
• Editors: Obuchowski, Nancy A; Gazelle, G. Scott
• Contents: Contributors Chapter 1: Imaging Technology Assessment; Pari V. Pandharipande and G. Scott Gazelle 1.1 Six Levels of Evidence: A Model of Technology Assessments in Imaging 1.1.1 Level 1: Technical Efficacy 1.1.2 Level 2: Diagnostic Accuracy 1.1.3 Levels 3 & 4: Impact on Diagnostic Thinking and Therapeutic Planning 1.1.4 Level 5: Patient Outcomes 1.1.5 Level 6: Societal Efficacy 1.2 Case Examples: Introducing Technology Assessment Methods into Study Design 1.3 Conclusion Chapter 2: Clinical Trials of Therapy; Sayeh Lavasani, Ali Mahinbakht and Anthony F. . Shields 2.1 Phase I, II, and III: Their Goals and Rationale 2.2 Therapeutic Roles: Prevention, Cure, and Palliation 2.3 Roles of Different Modalities 2.3.1 Surgery 2.3.2 Radiation therapy 2.3.3 Chemotherapy combinations 2.4 Study Planning 2.4.1 Sources for protocol ideas 2.4.2 Choice of primary and secondary objectives 2.4.3 Ways to speed protocol writing 2.4.4 Inclusion and exclusion criteria 2.4.4.1 Co-morbid conditions 2.4.4.2 Laboratory values 2.4.4.3 Trial time requirements, . risk and accrual 2.4.5 Subject registration and accrual goals 2.4.6 Evaluation schedule 2.4.7 Treatment schedule 2.4.8 Assessment of toxicity and reporting adverse advents 2.4.9 Scheme for dose modification 2.4.10 Data collection and documentation 2.5 The Protocol Review Process 2.6 Funding and Budgeting 2.7 Enhancing Protocol Accrual Chapter 3: Clinical Trials of Image Guided Interventions Including Radiotherapy Studies; Gary S. Dorfman and Stephen M. . Hahn 3.1 Introduction 3.2 Establishing the Context for IGI Clinical Trials 3.2.1 Clinical utilities 3.2.2 Translational continuum 3.2.3 Why do IGI clinical trials differ from other therapy or imaging trials 3.3 A Paradigm for Considering IGI Clinical Trial Design; ; 3.4 Radiotherapy Trials 3.4 Radiotherapy Trials 3.4.1 Pre-clinical radiotherapy studies 3.4.2 Phase I radiotherapy studies 3.4.3 Phase II/III radiotherapy studies 3.5 Caveats in the Design and Conduct of IGI Trials 3.5.1 Defining the clinical trial cohort 3.5.2 Standardization of the study procedures and quality assurance 3.5.3 IGI trial quality assurance 3.5.4 IGI clinical trial endpoints: measures of success and failure 3.6 Potential Impediments to the Design and Conduct of IGI Clinical Trials 3.6.1 Evaluation of the placebo effect 3.6.2 Masking or blinding of investigators . 3.6.3 Impediments related to “Standard of Care” control interventions 3.6.4 Rapid evolution of the IGI device and related devices multiple competitive IGI devices 3.6.5 The feasibility of randomized clinical trials of IGIs 3.6.6 Impediments to and pitfall in the conduct of the trial 3.7 Special Considerations and the Future 3.7.1 Conclusion Chapter 4: Imaging as Predictor of Therapeutic Response; David A. Mankoff and Anthony F. . Shields 4.1 Introduction 4.1.1 What is a biomarker? 4.1.2 Why do we need imaging biomarkers to direct therapy? 4.1.3 Types of therapeutic biomarkers 4.2 Imaging – Versus Tissue-based Biomarkers 4.3 Examples of Imaging Biomarker Applications 4.3.1 Prognostic markers 4.3.2 Predictive markers 4.3.3 Early response markers 4.3.4 Therapeutic benefit markers and surrogate measurements for long-term outcomes 4.4 Approach to biomarker study design 4.4.1 Standards for biomarker clinical trial design and results reporting 4.4.2 Integral versus integrated biomarkers 4.4.3 Altering therapy with early response markers 4.5 Practical Considerations 4.6 Conclusions Chapter 5: Screening Trials and Design; Constance D. Lehman and Diana L. . Miglioretti 5.1 Principles of Screening 5.1.1 Natural History of disease 5.1.2 Screening test characteristics 5.2 Screening Cascade 5.2.1 Negative test results 5.2.2 Positive test results 5.2.3 Incidental findings 5.3 Developing a Screening Trial Protocol 5.3.1 Identify the target population 5.3.2 Determine the screening regimens to be compared 5.3.3 Select clinical efficacy goals 5.3.4 Balance the benefits and potential harms of screening 5.4 Selecting a Study Design 5.4.1 Randomized controlled trials 5.4.2 Observational studies 5.4.3 Role of computer simulation modeling 5.4.4 Illustrative examples of imaging-based screening trials Chapter 6: Practicalities of Running a Trial; Michael T. Lu, Elizabeth C. . Adami and Udo Hoffmann 6.1 Types of Clinical Trials 6.2 Practical Issues in Designing a Clinical Trial 6.2.1 Do the right trial 6.2.2 Define trial complexity 6.3 Case of CCTA 6.3.1 Costs/Budgets 6.3.2 Team 6.3.3 Feasibility 6.3.4 Good practices 6.3.5 Multi-center trials 6.4 Operational Aspects of Conducting a Clinical Trial 6.4.1 Good Clinical Practice (GCP) 6.4.2 The Principal Investigator 6.4.3 Data Security 6.4.4 Study Management 6.4.5 Processing workflow 6.5 Audits 6.6 Summary Chapter 7: Statistical Issues in Study Design; Nancy A. . Obuchowski 7.1 Diversity in imaging study designs 7.2 Building blocks of an imaging research study 7.2.1 Turning research questions objectives and statistical hypotheses 7.2.2 Sampling from patient and reader populations 7.2.3 What is a reference standard? 7.3 Strategies for Efficient Studies 7.3.1 Retrospective or prospective? 7.3.2 Paired designs 7.3.3 Augmented and enriched designs 7.3.4 Randomization 7.3.5 Interim Analyses 7.4 Common Biases in Imaging Studies 7.4.1 Spectrum bias 7.4.2 Verification bias 7.5 Sample size considerations 7.5.1 Under-powered studies: clinical vs. statistical significance 7.5.2 Factors affecting sample size 7.5.3 Sample size calculations 7.5.4 Example sample size considerations for MRMC study Chapter 8: Introduction to Biostatistical Methods; Diana L. Miglioretti, Todd A. Alonzo and Nancy A. . Obuchowski 8.1 Role of Biostatistics in Clinical Imaging Research 8.2 Descriptive and Exploratory Data Analysis 8.2.1 Summary Statistics 8.2.1.1 Measures of central tendency 8.2.1.2 Measures of dispersion 8.2.1.3 Confidence Intervals 8.2.2 Graphs 8.3 Confirmatory Data Analysis (i.e., Hypothesis Testing) 8.3.1 Formulating the null and alternative hypotheses 8.3.2 Significance level, test statistics, . and p-values 8.3.3 Types of hypothesis tests 8.3.3.1 Test for difference 8.3.3.2 Test for superiority 8.3.3.3 Test for equivalence 8.3.3.4 Test for non-inferiority 8.4 More on p-values 8.4.1 Problems with p-values 8.4.2 Relationship between p-values and confidence intervals 8.5 Advanced Topics: Statistical Modeling 8.5.1 Linear regression 8.5.2 Logistic regression Chapter 9: Methods of Studies of Diagnostic Tests; Jeffrey D. Blume 9.1 Introduction 9.2 Sources of Variation 9.3 Assessing the Agreement Among Multiple Tests <.
• Publisher Details: Hoboken, New Jersey : Wiley-Blackwell
• Publication Date: 2016
• Extent: 1 online resource, illustrations (black and white, and colour)
• Subjects: 616.0754; Diagnostic imaging; Clinical trials; Radiotherapy; Computer-assisted surgery
• Languages: English
• ISBNs: 9781118849736
• Related ISBNs: 9781118849750
• Notes: Note: Includes bibliographical references and index.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.