Opis: Design - Iftekhar Khan

Economic evaluation has become an essential component of clinical trial design to show that new treatments and technologies offer value to payers in various healthcare systems. Although many books exist that address the theoretical or practical aspects of cost-effectiveness analysis, this book differentiates itself from the competition by detailing how to apply health economic evaluation techniques in a clinical trial context, from both academic and pharmaceutical/commercial perspectives. It also includes a special chapter for clinical trials in Cancer. Design & Analysis of Clinical Trials for Economic Evaluation & Reimbursement is not just about performing cost-effectiveness analyses. It also emphasizes the strategic importance of economic evaluation and offers guidance and advice on the complex factors at play before, during, and after an economic evaluation. Filled with detailed examples, the book bridges the gap between applications of economic evaluation in industry (mainly pharmaceutical) and what students may learn in university courses. It provides readers with access to SAS and STATA code. In addition, Windows-based software for sample size and value of information analysis is available free of charge-making it a valuable resource for students considering a career in this field or for those who simply wish to know more about applying economic evaluation techniques. The book includes coverage of trial design, case report form design, quality of life measures, sample sizes, submissions to regulatory authorities for reimbursement, Markov models, cohort models, and decision trees. Examples and case studies are provided at the end of each chapter. Presenting first-hand insights into how economic evaluations are performed from a drug development perspective, the book supplies readers with the foundation required to succeed in an environment where clinical trials and cost-effectiveness of new treatments are central. It also includes thought-provoking exercises for use in classroom and seminar discussions.Introduction to Economic Evaluation Health Economics, Pharmacoeconomics, and Economic Evaluation Important Concepts in Economic Evaluation Health Economic Evaluation and Drug Development Efficacy, Effectiveness and Efficiency When Is a Pharmacoeconomic Hypothesis Possible? Exercises Health Economic Evaluation Concepts Incremental Cost-Effectiveness Ratio (ICER) Incremental INMB The Concept of Dominance Types of Economic Evaluation Statistical versus Health Economic Models Exercises Appendix SAS/STATA Code Designing Cost-Effectiveness into a Clinical Trial Reasons for Collecting Economic Data in a Clinical Trial Planning a Health Economic Evaluation in a Clinical Trial Clinical Trial Design Issues in an Economic Evaluation Integrating Economic Evaluation in a Clinical Trial: Considerations CRF Design and Data Management Issues Case Study of a Lung Cancer Trial with an Economic Evaluation Exercises Appendix: SAS/STATA Analysing Cost Data Collected in a Clinical Trial Collecting and Measuring Costs for the Case Report Form Types of Costs Other Concepts in Costs: Time Horizon and Discounting CRFs for Collecting Resource Use Data in Clinical Trials Statistical Modelling of Cost Data Using Generalised Linear Models to Analyse Cost Data Models for Skewed Distributions Outside the GLM Family of Distributions Summary of Modelling Approaches Handling Censored and Missing Costs Strategies for Avoiding Missing Resource Data Strategies for Analysing Cost Data When Data Are Missing or Censored Imputation Methods Censored Cost Data Method of Lin et al. (1997) Summary and Conclusion Exercises Appendix: SAS/STATA Code Quality of Life in Economic Evaluation Quality of Life in Clinical Trials versus Quality of Life for Economic Evaluation Disease-Specific and Generic Measures of HRQoL HRQoL Instruments Used for the Purposes of Economic Evaluation When HRQoL Data Have Not Been Collected in a Clinical Trial HRQoL Metrics for Use in Economic Evaluations Are Utility Measures Sensitive Enough for Detecting Treatment Differences? Exercises Appendix 5A SAS/STATA Code Technical Appendix: Beta Binomial Technical Details Technical Appendix: Technical Summary of the GLM Modelling in Economic Evaluation Introduction to Modelling: Statistical versus Economic Modelling Decision Tree Models Markov Modelling/Cohort Simulation Analysis of Patient-Level Data Patient-Level Simulation Other Issues in Modelling Exercises Appendix: SAS/STATA Code Sensitivity Analyses Introduction to Sensitivity Analysis One-Way Sensitivity Analysis Two-Way Sensitivity Analysis PSA Bayesian Sensitivity Analyses Issues in Interpreting and Reporting Results from Sensitivity Analysis Exercises Appendix: SAS/STATA Code Sample Size and Value of Information for Cost-Effectiveness Trials Introduction Sample Sizes for Cost-Effectiveness Sample Size Methods for Efficacy Sample Size Formulae for Cost-Effectiveness: Examples Factors Affecting Sample Sizes The Minimum Sample Size to Establish Cost-Effectiveness Bayesian Sample Size Approach The Normality Assumption Obtaining the Necessary Data and Tools for Calculating Sample Size Value of Information Exercises for Chapter 8 Appendix 8A SAS/STATA Code Technical Appendix 8B Derivation of Sample Size Formula Technical Appendix 8C Comparison with Briggs and Tambour's (2001) Approach Mixed Treatment Comparisons, Evidence Synthesis Introduction MTCs Meta-Analysis Exercises Appendix: SAS/STATA Code Cost-Effectiveness Analyses of Cancer Trials Introduction Modelling Patient-Level Data from Cancer Trials for Cost- Effectiveness Flexible Parametric Survival Models Modelling Survival Data Using a Flexible Parametric Model Cost-Effectiveness of Lenalidomide Transition Probabilities and Survival Rates Handling Crossover (Treatment Switching) in Cancer Trials Landmark Analysis and Presenting Survival Data by Tumour Response Exercises Appendix: SAS/STATA Code The Reimbursement Environment Regulatory Requirements for Clinical Efficacy versus Payer Requirements for Value Reimbursement and Payer Evidence Requirements across Different Countries Market Access and Strategy Value-Based Pricing Submissions for Payer Evidence Further Areas for Research Exercises References Bibliography Index

Szczegóły: Design - Iftekhar Khan

Tytuł: Design
Autor: Iftekhar Khan
Producent: CRC Press Inc.
ISBN: 9781466505476
Rok produkcji: 2015
Ilość stron: 339
Oprawa: Twarda
Waga: 0.61 kg

Recenzje: Design - Iftekhar Khan