Design & Analysis of Clinical Trials for Economic Evaluation & Reimbursement

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.

Iftekhar Khan is a statistician, health economics researcher and academic at University College London (University of London). He has been an applied statistician for over 15 years in clinical trials, having worked in pharmaceutical companies and academic clinical trials units. Iftekhar Khan has completed degrees in statistics and mathematics from King's College London, the University of Kent and the University of Cambridge, including a master's in health economics and a PhD in health economic modelling (University College London).

Introduction to Economic Evaluation. Health Economic Evaluation Concepts. Designing Cost-Effectiveness into a Clinical Trial. Analyzing Cost Data Collected in a Clinical Trial. Quality of Life in Economic Evaluation. Modelling in Economic Evaluation. Sensitivity Analyses. Sample Size and Value of Information for Cost-Effectiveness Trials. Mixed Treatment Comparisons, Evidence Synthesis. Cost-Effectiveness Analyses of Cancer Trials. The Reimbursement Environment. References. Bibliography. Index.