eBook PDF Download Digital Library
Author: M. Elizabeth Halloran
Publisher: Springer Science & Business Media
Published: 2009-10-27
Total Pages: 390
ISBN-13: 0387686363
DOWNLOAD EBOOK →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.
Author: Institute of Medicine
Publisher: National Academies Press
Published: 2013-04-27
Total Pages: 237
ISBN-13: 0309267021
DOWNLOAD EBOOK →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.
Author: Institute of Medicine
Publisher: National Academies Press
Published: 2005-04-29
Total Pages: 152
ISBN-13: 0309165245
DOWNLOAD EBOOK →The Vaccine Safety Datalink (VSD) is a large, linked database of patient information that was developed jointly by CDC and several private managed care organizations in 1991. It includes data on vaccination histories, health outcomes, and characteristics of more than 7 million patients of eight participating health organizations. Researchers from CDC and the managed care groups have used VSD information to study whether health problems are associated with vaccinations. The subsequent VSD data sharing program was launched in 2002 to allow independent, external researchers access to information in the database. In this report, the committee that was asked to review aspects of this program recommends that two new oversight groups are needed to ensure that the policies and procedures of the VSD and its data sharing program are implemented as fairly and openly as possible.
Author: Jay Bartroff
Publisher: Springer Science & Business Media
Published: 2012-12-12
Total Pages: 250
ISBN-13: 1461461146
DOWNLOAD EBOOK →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.
Author: Mark D. Rothmann
Publisher: CRC Press
Published: 2016-04-19
Total Pages: 451
ISBN-13: 1584888059
DOWNLOAD EBOOK →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
Author: Institute of Medicine
Publisher: National Academies Press
Published: 2001-01-01
Total Pages: 221
ISBN-13: 0309171148
DOWNLOAD EBOOK →Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.
Author: Sunil Thomas
Publisher:
Published: 2016
Total Pages: 873
ISBN-13: 9781493933877
DOWNLOAD EBOOK →Author: Institute of Medicine
Publisher: National Academies Press
Published: 1993-02-01
Total Pages: 238
ISBN-13: 0309049407
DOWNLOAD EBOOK →The Children's Vaccine Initiative is an international endeavor to ensure that children throughout the world are immunized. This book notes that one of the best opportunities to address the growing problem of immunization in the United States and to improve the health of children in developing countries lies in marshaling the vaccine development and production efforts in the United States and abroad. The book contains information on the nature and status of vaccine development and production efforts in the United States and abroad, and it recommends ways to enhance participation in the International Children's Vaccine Initiative.
Author: Institute of Medicine
Publisher: National Academies Press
Published: 2001-02-21
Total Pages: 472
ISBN-13: 0309174988
DOWNLOAD EBOOK →Vaccines have made it possible to eradicate the scourge of smallpox, promise the same for polio, and have profoundly reduced the threat posed by other diseases such as whooping cough, measles, and meningitis. What is next? There are many pathogens, autoimmune diseases, and cancers that may be promising targets for vaccine research and development. This volume provides an analytic framework and quantitative model for evaluating disease conditions that can be applied by those setting priorities for vaccine development over the coming decades. The committee describes an approach for comparing potential new vaccines based on their impact on morbidity and mortality and on the costs of both health care and vaccine development. The book examines: Lessons to be learned from the polio experience. Scientific advances that set the stage for new vaccines. Factors that affect how vaccines are used in the population. Value judgments and ethical questions raised by comparison of health needs and benefits. The committee provides a way to compare different forms of illness and set vaccine priorities without assigning a monetary value to lives. Their recommendations will be important to anyone involved in science policy and public health planning: policymakers, regulators, health care providers, vaccine manufacturers, and researchers.
Author: Neil Z. Miller
Publisher:
Published: 2016
Total Pages: 0
ISBN-13: 9781881217404
DOWNLOAD EBOOK →Many people sincerely believe that all vaccines are safe, adverse reactions are rare, and no peer-reviewed scientific studies exist showing that vaccines can cause harm. This book -- Miller's Review of Critical Vaccine Studies -- provides the other side of the story that is not commonly told. It contains summaries of 400 important scientific papers to help parents and researchers enhance their understanding of vaccinations. "This book should be required reading for every doctor, medical student and parent. Reading this book will allow you to make better choices when considering vaccination." -- David Brownstein, MD "This book is so precise and exciting in addressing the vaccine controversy that I read it in one evening. I recommend this book to any parent who has questions about vaccines and wants to be factually educated to make informed decisions." -- Gabriel Cousens, MD "Neil Miller's book is a tour de force and a clarion voice championing the cautionary principle: 'When in doubt, minimize risk.' Let's talk science. Read this book. The truth will keep you and your children protected."-- Bradford S. Weeks, MD "Nowhere else can one find such an organized and concise compilation of research on vaccines. Not only does Miller have a deep understanding of science and the issues at hand, he has made this book easy to reference and cite. Truly, there is no other guide out there quite like it. For everyone who contacts me in the future seeking scientific evidence about vaccines, I will recommend Miller's Review of Critical Vaccine Studies." -- Toni Bark, MD, MHEM, LEED AP, previous Director of the pediatric ER at Michael Reese Hospital "Miller's Review of Critical Vaccine Studies is the most comprehensive and coherent accumulation of peer-reviewed research on vaccine issues and natural immunity I have ever come across. A must read for parents, teachers, doctors and other healthcare providers." -- Dr. Tyson Perez, pediatric chiropractor
