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Statistics in Clinical Vaccine Trials

2010-10-07 Mathematics
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Release : 2010-10-07
Genre : Mathematics
Kind : eBook
Book Rating : 910/5 ( reviews)

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Book Synopsis Statistics in Clinical Vaccine Trials by : Jozef Nauta

Download or read book Statistics in Clinical Vaccine Trials written by Jozef Nauta. This book was released on 2010-10-07. Available in PDF, EPUB and Kindle. Book excerpt: This monograph offers well-founded training and expertise on the statistical analysis of data from clinical vaccine trials, i.e., immunogenicity and vaccine field efficacy studies. The book's scope is practical rather than theoretical. 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 statistical methodology. Many real-life examples and SAS codes are presented, making application of the methods straightforward. Topics discussed include maximum likelihood estimation for censored antibody titers, ANCOVA for antibody values, analysis of equivalence and non-inferiority immunogenicity trial data, analysis of data from vaccine field efficacy trials (including data from studies with recurrent infection data), fitting protection curves to data of challenge or field efficacy studies, and the analysis of vaccine safety data.

Statistics in Clinical and Observational Vaccine Studies

2020 Vaccines
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Release : 2020
Genre : Vaccines
Kind : eBook
Book Rating : 949/5 ( reviews)

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Book Synopsis Statistics in Clinical and Observational Vaccine Studies by : Jozef Nauta

Download or read book Statistics in Clinical and Observational Vaccine Studies written by Jozef Nauta. This book was released on 2020. Available in PDF, EPUB and Kindle. Book excerpt: This book offers training and expertise on the statistical analysis of data from clinical vaccine trials, i.e., immunogenicity and vaccine field efficacy studies. With many worked-out real-life examples, its scope is more practical than theoretical.

Statistics in Clinical and Observational Vaccine Studies

2020-03-14 Medical
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Release : 2020-03-14
Genre : Medical
Kind : eBook
Book Rating : 931/5 ( reviews)

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Book Synopsis Statistics in Clinical and Observational Vaccine Studies by : Jozef Nauta

Download or read book Statistics in Clinical and Observational Vaccine Studies written by Jozef Nauta. This book was released on 2020-03-14. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Design and Analysis of Vaccine Studies

2009-10-27 Medical
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Release : 2009-10-27
Genre : Medical
Kind : eBook
Book Rating : 363/5 ( reviews)

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Book Synopsis Design and Analysis of Vaccine Studies by : M. Elizabeth Halloran

Download or read book Design and Analysis of Vaccine Studies written by M. Elizabeth Halloran. This book was released on 2009-10-27. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Sharing Clinical Trial Data

2015-04-20 Medical
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Release : 2015-04-20
Genre : Medical
Kind : eBook
Book Rating : 324/5 ( reviews)

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Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine

Download or read book Sharing Clinical Trial Data written by Institute of Medicine. This book was released on 2015-04-20. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

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