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With ever-rising healthcare costs, evidence generation through
Health Economics and Outcomes Research (HEOR) plays an increasingly
important role in decision-making about the allocation of
resources. Accordingly, it is now customary for health technology
assessment and reimbursement agencies to request for HEOR evidence,
in addition to data from clinical trials, to inform decisions about
patient access to new treatment options. While there is a great
deal of literature on HEOR, there is a need for a volume that
presents a coherent and unified review of the major issues that
arise in application, especially from a statistical perspective.
Statistical Topics in Health Economics and Outcomes Research
fulfils that need by presenting an overview of the key analytical
issues and best practice. Special attention is paid to key
assumptions and other salient features of statistical methods
customarily used in the area, and appropriate and relatively
comprehensive references are made to emerging trends. The content
of the book is purposefully designed to be accessible to readers
with basic quantitative backgrounds, while providing an in-depth
coverage of relatively complex statistical issues. The book will
make a very useful reference for researchers in the pharmaceutical
industry, academia, and research institutions involved with HEOR
studies. The targeted readers may include statisticians, data
scientists, epidemiologists, outcomes researchers, health
economists, and healthcare policy and decision-makers.
With ever-rising healthcare costs, evidence generation through
Health Economics and Outcomes Research (HEOR) plays an increasingly
important role in decision-making about the allocation of
resources. Accordingly, it is now customary for health technology
assessment and reimbursement agencies to request for HEOR evidence,
in addition to data from clinical trials, to inform decisions about
patient access to new treatment options. While there is a great
deal of literature on HEOR, there is a need for a volume that
presents a coherent and unified review of the major issues that
arise in application, especially from a statistical perspective.
Statistical Topics in Health Economics and Outcomes Research
fulfils that need by presenting an overview of the key analytical
issues and best practice. Special attention is paid to key
assumptions and other salient features of statistical methods
customarily used in the area, and appropriate and relatively
comprehensive references are made to emerging trends. The content
of the book is purposefully designed to be accessible to readers
with basic quantitative backgrounds, while providing an in-depth
coverage of relatively complex statistical issues. The book will
make a very useful reference for researchers in the pharmaceutical
industry, academia, and research institutions involved with HEOR
studies. The targeted readers may include statisticians, data
scientists, epidemiologists, outcomes researchers, health
economists, and healthcare policy and decision-makers.
Advancing the development, validation, and use of patient-reported
outcome (PRO) measures, Patient-Reported Outcomes: Measurement,
Implementation and Interpretation helps readers develop and enrich
their understanding of PRO methodology, particularly from a
quantitative perspective. Designed for biopharmaceutical
researchers and others in the health sciences community, it
provides an up-to-date volume on conceptual and analytical issues
of PRO measures. The book discusses key concepts relating to the
measurement, implementation, and interpretation of PRO measures. It
covers both introductory and advanced psychometric and
biostatistical methods for constructing and analyzing PRO measures.
The authors include many relevant real-life applications based on
their extensive first-hand experiences in the pharmaceutical
industry. They implement a wealth of simulated datasets to
illustrate concepts and heighten understanding based on practical
scenarios. For readers interested in conducting statistical
analyses of PRO measures and delving more deeply into the analytic
details, most chapters contain SAS code and output that illustrate
the methodology. Along with providing numerous references, the book
highlights current regulatory guidelines.
Advancing the development, validation, and use of patient-reported
outcome (PRO) measures, Patient-Reported Outcomes: Measurement,
Implementation and Interpretation helps readers develop and enrich
their understanding of PRO methodology, particularly from a
quantitative perspective. Designed for biopharmaceutical
researchers and others in the health sciences community, it
provides an up-to-date volume on conceptual and analytical issues
of PRO measures. The book discusses key concepts relating to the
measurement, implementation, and interpretation of PRO measures. It
covers both introductory and advanced psychometric and
biostatistical methods for constructing and analyzing PRO measures.
The authors include many relevant real-life applications based on
their extensive first-hand experiences in the pharmaceutical
industry. They implement a wealth of simulated datasets to
illustrate concepts and heighten understanding based on practical
scenarios. For readers interested in conducting statistical
analyses of PRO measures and delving more deeply into the analytic
details, most chapters contain SAS code and output that illustrate
the methodology. Along with providing numerous references, the book
highlights current regulatory guidelines.
This book provides an overview of the theories and applications on
subgroups in the biopharmaceutical industry. Drawing from a range
of expert perspectives in academia and industry, this collection
offers an overarching dialogue about recent advances in
biopharmaceutical applications, novel statistical and
methodological developments, and potential future directions. The
volume covers topics in subgroups in clinical trial design;
subgroup identification and personalized medicine; and general
issues in subgroup analyses, including regulatory ones. Included
chapters present current methods, theories, and case applications
in the diverse field of subgroup application and analysis. Offering
timely perspectives from a range of authoritative sources, the
volume is designed to have wide appeal to professionals in the
pharmaceutical industry and to graduate students and researchers in
academe and government.
This book focuses on how to appropriately plan and develop a Phase
II program, and how to design Phase II clinical trials and analyze
their data. It provides a comprehensive overview of the entire drug
development process and highlights key questions that need to be
addressed for the successful execution of Phase II, so as to
increase its success in Phase III and for drug approval. Lastly it
warns project team members of the common potential pitfalls and
offers tips on how to avoid them.
This book focuses on how to appropriately plan and develop a Phase
II program, and how to design Phase II clinical trials and analyze
their data. It provides a comprehensive overview of the entire drug
development process and highlights key questions that need to be
addressed for the successful execution of Phase II, so as to
increase its success in Phase III and for drug approval. Lastly it
warns project team members of the common potential pitfalls and
offers tips on how to avoid them.
This book provides an overview of the theories and applications on
subgroups in the biopharmaceutical industry. Drawing from a range
of expert perspectives in academia and industry, this collection
offers an overarching dialogue about recent advances in
biopharmaceutical applications, novel statistical and
methodological developments, and potential future directions. The
volume covers topics in subgroups in clinical trial design;
subgroup identification and personalized medicine; and general
issues in subgroup analyses, including regulatory ones. Included
chapters present current methods, theories, and case applications
in the diverse field of subgroup application and analysis. Offering
timely perspectives from a range of authoritative sources, the
volume is designed to have wide appeal to professionals in the
pharmaceutical industry and to graduate students and researchers in
academe and government.
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