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Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309316324
Category : Medical
Languages : en
Pages : 236
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Book Description
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.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309316324
Category : Medical
Languages : en
Pages : 236
Get Book Here
Book Description
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.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309171148
Category : Medical
Languages : en
Pages : 221
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Book Description
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: American Statistical Association
Publisher:
ISBN:
Category : Statistics
Languages : en
Pages : 504
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Book Description
Author: Ronny S. Mans
Publisher: Springer
ISBN: 3319160710
Category : Computers
Languages : en
Pages : 99
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Book Description
What are the possibilities for process mining in hospitals? In this book the authors provide an answer to this question by presenting a healthcare reference model that outlines all the different classes of data that are potentially available for process mining in healthcare and the relationships between them. Subsequently, based on this reference model, they explain the application opportunities for process mining in this domain and discuss the various kinds of analyses that can be performed. They focus on organizational healthcare processes rather than medical treatment processes. The combination of event data and process mining techniques allows them to analyze the operational processes within a hospital based on facts, thus providing a solid basis for managing and improving processes within hospitals. To this end, they also explicitly elaborate on data quality issues that are relevant for the data aspects of the healthcare reference model. This book mainly targets advanced professionals involved in areas related to business process management, business intelligence, data mining, and business process redesign for healthcare systems as well as graduate students specializing in healthcare information systems and process analysis.
Author: Dr Vincent Cassar
Publisher: Academic Conferences Limited
ISBN: 1910810118
Category : Business & Economics
Languages : en
Pages : 478
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Book Description
Complete proceedings of the 14th European Conference on Research Methodology for Business and Management Studies Valletta, Malta Published by Academic Conferences and Publishing International
Author: Mukul S. Bansal
Publisher: Springer Nature
ISBN: 303117531X
Category : Computers
Languages : en
Pages : 184
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Book Description
This book constitutes revised selected papers from the refereed proceedings of the 11th International Conference on Computational Advances in Bio and Medical Sciences, ICCABS 2021, held as a virtual event during December 16–18, 2021. The 13 full papers included in this book were carefully reviewed and selected from 17 submissions. They were organized in topical sections as follows: Computational advances in bio and medical sciences; and computational advances in molecular epidemiology.
Author: Roger Bakeman
Publisher: Cambridge University Press
ISBN: 1139504606
Category : Psychology
Languages : en
Pages : 201
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Book Description
Behavioral scientists – including those in psychology, infant and child development, education, animal behavior, marketing and usability studies – use many methods to measure behavior. Systematic observation is used to study relatively natural, spontaneous behavior as it unfolds sequentially in time. This book emphasizes digital means to record and code such behavior; while observational methods do not require them, they work better with them. Key topics include devising coding schemes, training observers and assessing reliability, as well as recording, representing and analyzing observational data. In clear and straightforward language, this book provides a thorough grounding in observational methods along with considerable practical advice. It describes standard conventions for sequential data and details how to perform sequential analysis with a computer program developed by the authors. The book is rich with examples of coding schemes and different approaches to sequential analysis, including both statistical and graphical means.
Author: Shein-Chung Chow
Publisher: CRC Press
ISBN: 1439839883
Category : Mathematics
Languages : en
Pages : 368
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Book Description
With new statistical and scientific issues arising in adaptive clinical trial design, including the U.S. FDA's recent draft guidance, a new edition of one of the first books on the topic is needed. Adaptive Design Methods in Clinical Trials, Second Edition reflects recent developments and regulatory positions on the use of adaptive designs in clini
Author: Edward Alan Fox
Publisher:
ISBN:
Category : Digital libraries
Languages : en
Pages : 512
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Book Description
Author: Ion Mandoiu
Publisher: Springer
ISBN: 3642015514
Category : Science
Languages : en
Pages : 350
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Book Description
This book constitutes the refereed proceedings of the 5th International Symposium on Bioinformatics Research and Applications, ISBRA 2009, held in Fort Lauderdale, FL, USA, in May 2009. The 26 revised full papers presented together four invited papers were carefully reviewed and selected from a total of 55 submissions. The papers cover a wide range of topics, including clustering and classification, gene expression analysis, gene networks, genome analysis, motif finding, pathways, protein structure prediction, protein domain interactions, phylogenetics, and software tools.
