Design And Analysis Of Vaccine Studies
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Design And Analysis Of Vaccine Studies
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Author : M. Elizabeth Halloran
language : en
Publisher: Springer Science & Business Media
Release Date : 2009-10-27
Design And Analysis Of Vaccine Studies written by M. Elizabeth Halloran and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-10-27 with Medical categories.
As well as being a reference for the design, analysis, and interpretation of vaccine studies, the text covers all design and analysis stages, from vaccine development to post-licensure surveillance, presenting likelihood, frequentists, and Bayesian approaches.
The Design And Analysis Of Post Licensure Vaccine Safety Studies
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Author : Nicholas J. Andrews
language : en
Publisher:
Release Date : 2013
The Design And Analysis Of Post Licensure Vaccine Safety Studies written by Nicholas J. Andrews and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013 with categories.
Trial Design And Analysis Of Endpoints In Hiv Vaccine Trials
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Author : Laura Richert
language : en
Publisher:
Release Date : 2013
Trial Design And Analysis Of Endpoints In Hiv Vaccine Trials written by Laura Richert and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013 with categories.
Complex data are frequently recored in recent clinical trials and require the use of appropriate statistical methods. HIV vaccine research is an example of a domaine with complex data and a lack of validated endpoints for early-stage clinical trials. This thesis concerns methodological research with regards to the design and analysis aspects of HIV vaccine trials, in particular the definition of immunogenicity endpoints and phase I-II trial designs. Using cytokine multiplex data, we illustrate the methodological aspects specific to a given assay technique. We then propose endpoint definitions and statistical methods appropriate for the analysis of multidimensional immunogenicity data. We show in particular the value of non-parametric multivariate scores, which allow for summarizing information across different immunogenicity markers and for making statistical comparisons between and within groups. In the aim of contributing to the design of new vaccine trials, we present the construction of an optimized early-stage HIV vaccine design. Combining phase I and II assessments, the proposed design allows for accelerating the clinical development of several vaccine strategies in parallel. The integration of a stopping rule is proposed from both a frequentist and a Bayesian perspective. The methods advocated in this thesis are transposable to other research domains with complex data, such as imaging data or trials of other immune therapies.
The Childhood Immunization Schedule And Safety
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2013-04-27
The Childhood Immunization Schedule And Safety written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-04-27 with Medical categories.
Vaccines are among the most safe and effective public health interventions to prevent serious disease and death. Because of the success of vaccines, most Americans today have no firsthand experience with such devastating illnesses as polio or diphtheria. Health care providers who vaccinate young children follow a schedule prepared by the U.S. Advisory Committee on Immunization Practices. Under the current schedule, children younger than six may receive as many as 24 immunizations by their second birthday. New vaccines undergo rigorous testing prior to receiving FDA approval; however, like all medicines and medical interventions, vaccines carry some risk. Driven largely by concerns about potential side effects, there has been a shift in some parents' attitudes toward the child immunization schedule. The Childhood Immunization Schedule and Safety identifies research approaches, methodologies, and study designs that could address questions about the safety of the current schedule. This report is the most comprehensive examination of the immunization schedule to date. The IOM authoring committee uncovered no evidence of major safety concerns associated with adherence to the childhood immunization schedule. Should signals arise that there may be need for investigation, however, the report offers a framework for conducting safety research using existing or new data collection systems.
Sequential Experimentation In Clinical Trials
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Author : Jay Bartroff
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-12
Sequential Experimentation In Clinical Trials written by Jay Bartroff and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-12 with Medical categories.
Sequential Experimentation in Clinical Trials: Design and Analysis is developed from decades of work in research groups, statistical pedagogy, and workshop participation. Different parts of the book can be used for short courses on clinical trials, translational medical research, and sequential experimentation. The authors have successfully used the book to teach innovative clinical trial designs and statistical methods for Statistics Ph.D. students at Stanford University. There are additional online supplements for the book that include chapter-specific exercises and information. Sequential Experimentation in Clinical Trials: Design and Analysis covers the much broader subject of sequential experimentation that includes group sequential and adaptive designs of Phase II and III clinical trials, which have attracted much attention in the past three decades. In particular, the broad scope of design and analysis problems in sequential experimentation clearly requires a wide range of statistical methods and models from nonlinear regression analysis, experimental design, dynamic programming, survival analysis, resampling, and likelihood and Bayesian inference. The background material in these building blocks is summarized in Chapter 2 and Chapter 3 and certain sections in Chapter 6 and Chapter 7. Besides group sequential tests and adaptive designs, the book also introduces sequential change-point detection methods in Chapter 5 in connection with pharmacovigilance and public health surveillance. Together with dynamic programming and approximate dynamic programming in Chapter 3, the book therefore covers all basic topics for a graduate course in sequential analysis designs.
Vaccinology And Methods In Vaccine Research
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Author : Rebecca Ashfield
language : en
Publisher: Academic Press
Release Date : 2022-03-10
Vaccinology And Methods In Vaccine Research written by Rebecca Ashfield and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-03-10 with Medical categories.
Vaccinology and Methods in Vaccine Research is a combination of cutting-edge methodologies, experimental approaches and literature reviews. The book covers all aspects of vaccine development, including basic immunology (focusing on the stimulation of adaptive immunity, which is required for vaccine efficacy), approaches to vaccine design and target validation, vaccine biomanufacturer and clinical development. Existing vaccinology resources are theoretical reference books, whereas this book provides a practical handbook for use in the research lab and classroom by those working in vaccinology and training others in the field. It is authored and edited by scientists actively engaged in vaccine research and development for day-to-day teaching/methodological advice. Addresses how to design a vaccine for an emerging disease, from a practical point-of -view, with chapters written by scientists who are grappling with these questions Provides new approaches to vaccine development. including vaccine targeting and virus-like-particle vaccines Gives up-to-date information and methodologies in use for vaccine adjuvants
Design And Analysis Of Non Inferiority Trials
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Author : Mark D. Rothmann
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Design And Analysis Of Non Inferiority Trials written by Mark D. Rothmann and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Mathematics categories.
The increased use of non-inferiority analysis has been accompanied by a proliferation of research on the design and analysis of non-inferiority studies. Using examples from real clinical trials, Design and Analysis of Non-Inferiority Trials brings together this body of research and confronts the issues involved in the design of a non-inferiority tr
Human Vaccines
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Author : Kayvon Modjarrad
language : en
Publisher: Academic Press
Release Date : 2016-10-15
Human Vaccines written by Kayvon Modjarrad and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-10-15 with Medical categories.
Human Vaccines: Emerging Technologies in Design and Development discusses the advances in molecular biology, biophysics, and informatics—among other disciplines—that have provided scientists with the tools to create new vaccines against emerging and re-emerging pathogens. For example, the virus-like particle technologies that led to licensing of highly efficacious HPV vaccines have only come into full realization in the last 10 years. Their success has, in turn, accelerated the pace with which nanoparticle vaccines are being developed Given the rapidity with which the field is changing and the absence of any text documenting this change, there is a need for a resource that surveys these new vaccine technologies, assesses their potential, and describes their applications. This book provides that resource and complements traditional vaccinology books, but also serves as an excellent standalone for researchers and students with basic knowledge in immunology. Introduces new topics in vaccine immunology in the context vaccine design and production Consolidates the growing body of knowledge on new vaccine technologies that have only emerged in the past 2 – 3 decades Reviews the currently licensed vaccines that have utilized leading-edge technologies and how this has translated into improved efficacy and safety Provides a broad overview of innovative vaccine technologies, including immunological aspects
Accounting For Subject Level Heterogeneity In Sieve Analysis Of Vaccine Efficacy
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Author : Jason Shao
language : en
Publisher:
Release Date : 2017
Accounting For Subject Level Heterogeneity In Sieve Analysis Of Vaccine Efficacy written by Jason Shao and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017 with categories.
In randomized trials of preventative vaccines, sieve analysis tests whether vaccine efficacy differs by a characteristic of the disease endpoint. These methods often assume a leaky model, in which treatment proportionally reduces the hazard of each disease type homogeneously in all subjects. Significant biases can occur in estimation and testing when this assumption does not hold. To allow for unobserved heterogeneity in participant response to vaccination, we propose a frailty mixture model for sieve analysis which incorporates unobserved, subject- level, random effects into a competing risks survival analysis framework. We show that parameters in the model can be straightforwardly and reliably estimated using standard numeric optimization methods. In simulation studies, our approach performs favorably to existing methods in cases where the leaky vaccine assumption is not appropriate. Finally, we implement our method on existing clinical trial datasets and discuss the implications of our findings for the design and interpretation of vaccine efficacy studies.
Statistics In Clinical And Observational Vaccine Studies
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Author : Jozef Nauta
language : en
Publisher: Springer Nature
Release Date : 2020-03-14
Statistics In Clinical And Observational Vaccine Studies written by Jozef Nauta and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-03-14 with Medical categories.
This book offers an overview of the statistical methods used in clinical and observational vaccine studies. Pursuing a practical rather than theoretical approach, it presents a range of real-world examples with SAS codes, making the application of the methods straightforward. This revised edition has been significantly expanded to reflect the current interest in this area. It opens with two introductory chapters on the immunology of vaccines to provide readers with the necessary background knowledge. It then continues with an in-depth exploration of the analysis of immunogenicity data. Discussed are, amongst others, maximum likelihood estimation for censored antibody titers, ANCOVA for antibody values, analysis of data of equivalence, and non-inferiority immunogenicity studies. Other topics covered include fitting protection curves to data from vaccine efficacy studies, and the analysis of vaccine safety data. In addition, the book features four new chapters on vaccine field studies: an introductory one, one on randomized vaccine efficacy studies, one on observational vaccine effectiveness studies, and one on the meta-analysis of vaccine efficacy studies. The book offers useful insights for statisticians and epidemiologists working in the pharmaceutical industry or at vaccines institutes, as well as graduate students interested in pharmaceutical statistics.