Hopkins, MA, MBA, PhD / Goereer Health Technology Assessment

Using Biostatistics to Break the Barriers of Adopting New Medicines
Erscheinungsjahr 2014
ISBN: 978-1-4822-4453-3
Verlag: Taylor & Francis
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 276 Seiten

This book covers from an advanced leading edge point of view the options for different methods in an HTA. For each statistical option, the link to regulatory and reimbursement decisions are made. The book provides a gentle (no formula) introduction to common statistical methods and real life examples. The book answers the questions: why are some drugs and technologies granted regulatory or reimbursement approval and others are not? What can be done to improve the chance of approval?

Autoren/Hrsg.

Hopkins, MA, MBA, PhD, Robert B.

Goereer, Ron

Inhaltsverzeichnis

Preface
Why drugs fail
The need for this book

Regulation, reimbursement and Health Technology Assessment
Data requirements to complete an HTA
Cost effectiveness
Introduction to Health-Related-Quality-of-Life
Introduction to Resource Utilization and Costs
The Need for Modelling
Start with the trials: safety and efficacy
Secondary data requirements

Meta-analysis
Overview of Meta-analysis
Initial steps before a meta-analysis
Steps in a meta-analysis
Meta-analysis of Diagnostic Accuracy Studies

Network Meta-analysis
Steps in conducting a network meta-analysis
Bayesian mixed treatment comparisons
Network meta-analysis of diagnostic accuracy

Bayesian methods
Bayesian theorem
Steps in a Bayesian analysis
Advanced Bayesian Models

Survival Analysis
Kaplan Meier analysis
Exponential, Gompertz and Weibull models
Establishing and using risk equations
Acceptability of Surrogates
Survival adjustment for crossover bias
Building a life table from cross-sectional data

Costs and cost of illness studies
From clinical events to resource utilization to costs
Attribution and adjustment for comorbidities
Perspective and types of costs
Burden of illness study
Budget impact analysis

Health Related Quality of Life
Why quality of life?
Good properties of scales
Guidelines for using quality of life in HTA
From utility to Quality Adjusted Life Years
Assessing change in QOL scales
Mapping between quality of life scales

Missing data methods
Common trial gaps
Meta-analysis gaps
Unknown lifetime variances for costs

Concluding Remarks
Academic Writing From A Biostatistician’s Point Of View
Future Research
Improving Reimbursement Submissions

Über Autor(innen)

Robert Borden Hopkins PhD

Rob has been the biostatistician at the Programs for the Assessment of Technology in Health (PATH) Research Institute at McMaster University for the past 10 years, and has more than 25 years of experience in healthcare. His role as the biostatistician continues to include: educational support at the graduate level; designing and analyzing systematic reviews; designing, conducting and analyzing clinical studies (field evaluations); conducting economic evaluations, burden of illness studies and health technology assessments; and providing peer review for more than 20 academic journals and government agencies.

From this work experience, Rob was the lead biostatistician for more than 75 funded research projects worth over $15 million, which generated over 100 peer reviewed publications and abstracts, 40 technical reports for government, as well over 200 conference, academic or government presentations. Recent methodological issues explored include handling of missing data in meta-analysis, trials, and economic evaluations; network meta-analysis; trial-based economic analysis; and cost/burden of illness studies.

Rob has presented his research at the following conferences: Society of Medical Decision Making (SMDM), International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Drug Information Association (DIA), Canadian Association for Population Therapeutics (CAPT), Canadian Agency for Drugs and Technologies in Health (CADTH), Canadian Association for Health Services and Policy Research (CAHSPR), Society for Clinical Trials (SCT), Health Technology Assessment International (HTAi), Canadian Statistical Society (CSC), American Statistical Society (ASA), Canadian Health Economics Association, International Health Economics Association (IHEA).

Ron Goeree MA

"Professor Goeree is one of the pre-eminent HTA researchers and educators in the world," said Dr. O’Rourke President and CEO of Canadian Agency for Drugs and Technologies in Health (CADTH). Ron was the 2012 recipient of the CADTH HTA Excellence Award for lifetime and sustained achievement, he is co-editor of Value in Health and sits on the editorial boards of Medical Decision Making and the Journal of Medical Economics.

Ron has established workshops on HTA all over the world — from Singapore to Oslo, has published extensively (over 400 books, chapters, articles and abstracts). He has reviewed over 120 journal submissions, 80 national or provincial drug submissions or reports, served on nearly 50 industry advisory boards, and more than 60 government/decision-maker committees and boards.

Ron is currently Professor the Department of Clinical Epidemiology & Biostatistics, Faculty of Health Sciences at McMaster University in Hamilton, Ontario, Canada, where Ron is the founding field leader for graduate studies of Health Technology Assessment at McMaster University.

Ron’s research is conducted at the Programs for Assessment of Health Technology (PATH) Research Institute at St. Joseph's Healthcare Hamilton, where he been the Director since 2006. "As director of PATH, he has demonstrated the essential role health technology assessment can and should play in meeting the needs of health of health decision-makers. As an innovator, he helped pioneer the methodological framework for the field evaluation of non-drug technologies. As a dedicated professor and mentor, he has trained literally thousands of students, researchers, and decision-makers, making an immense contribution to the capacity in Canada to produce and use health technology assessment," said O'Rourke.