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Phase 3 Interim Report Summary
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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 and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. 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.
Book Synopsis Low Altitude Atmospheric Turbulence LO-LOCAT Phase III Interim Report by : K. R. Monson
Download or read book Low Altitude Atmospheric Turbulence LO-LOCAT Phase III Interim Report written by K. R. Monson and published by . This book was released on 1969 with total page 540 pages. Available in PDF, EPUB and Kindle. Book excerpt: The contents of this report describe accomplishments during the first half of the Low-Level Critical Air Turbulence (LO-LOCAT) Phase III program. Data that were obtained during flight over routes near McConnell Air Force Base, Kansas, and Edwards Air Force Base, California, are presented. Also included are time histories of some of the larger magnitude gust velocities recorded over the Peterson Field, Colorado route. Approximately 72 hours of low-level (0-1000 feet) turbulence and associated meteorological data recorded from August 16, 1968, through January 8, 1969, are presented. The turbulence environment is analyzed in terms of gust velocity primary peaks, amplitude samples, rms values, maximum values and derived equivalent gusts. Mathematical expressions for turbulence spectra and scale length statistics, and correlations between atmospheric gust velocities and meteorological and geophysical phenomena are shown. The most predominant characteristics of these data are the increases in rms values, scale lengths, Taylor micro scales and maximum gust values as compared to the LO-LOCAT Phases I and II data. These differences are attributed to the increased speed of the Phase III airplane which is providing a better definition of the longer wavelengths of atmospheric turbulence. This report consists of two volumes. Volume I contains a discussion of data acquisition and quality, along with a preliminary analysis of turbulence and meteorological data.
Book Synopsis Scientific and Technical Aerospace Reports by :
Download or read book Scientific and Technical Aerospace Reports written by and published by . This book was released on 1971 with total page 792 pages. Available in PDF, EPUB and Kindle. Book excerpt: Lists citations with abstracts for aerospace related reports obtained from world wide sources and announces documents that have recently been entered into the NASA Scientific and Technical Information Database.
Book Synopsis Group Sequential Methods with Applications to Clinical Trials by : Christopher Jennison
Download or read book Group Sequential Methods with Applications to Clinical Trials written by Christopher Jennison and published by CRC Press. This book was released on 1999-09-15 with total page 416 pages. Available in PDF, EPUB and Kindle. Book excerpt: Group sequential methods answer the needs of clinical trial monitoring committees who must assess the data available at an interim analysis. These interim results may provide grounds for terminating the study-effectively reducing costs-or may benefit the general patient population by allowing early dissemination of its findings. Group sequential methods provide a means to balance the ethical and financial advantages of stopping a study early against the risk of an incorrect conclusion. Group Sequential Methods with Applications to Clinical Trials describes group sequential stopping rules designed to reduce average study length and control Type I and II error probabilities. The authors present one-sided and two-sided tests, introduce several families of group sequential tests, and explain how to choose the most appropriate test and interim analysis schedule. Their topics include placebo-controlled randomized trials, bio-equivalence testing, crossover and longitudinal studies, and linear and generalized linear models. Research in group sequential analysis has progressed rapidly over the past 20 years. Group Sequential Methods with Applications to Clinical Trials surveys and extends current methods for planning and conducting interim analyses. It provides straightforward descriptions of group sequential hypothesis tests in a form suited for direct application to a wide variety of clinical trials. Medical statisticians engaged in any investigations planned with interim analyses will find this book a useful and important tool.
Download or read book Technical Abstract Bulletin written by and published by . This book was released on with total page 828 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :Agency for Healthcare Research and Quality/AHRQ Publisher :Government Printing Office ISBN 13 :1587634333 Total Pages :385 pages Book Rating :4.5/5 (876 download)
Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ
Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.
Author :Agency for Health Care Research and Quality (U.S.) Publisher :Government Printing Office ISBN 13 :1587634236 Total Pages :236 pages Book Rating :4.5/5 (876 download)
Book Synopsis Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide by : Agency for Health Care Research and Quality (U.S.)
Download or read book Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide written by Agency for Health Care Research and Quality (U.S.) and published by Government Printing Office. This book was released on 2013-02-21 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)
Download or read book Highway Safety Literature written by and published by . This book was released on 1980 with total page 830 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Technical Reports of the National Highway Traffic Safety Administration; a Bibliography, 1978 by : L. Flynn (comp)
Download or read book Technical Reports of the National Highway Traffic Safety Administration; a Bibliography, 1978 written by L. Flynn (comp) and published by . This book was released on 1979 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Technical Reports of the National Highway Traffic Safety Administration; a Bibliography, 1977 by : L. Flynn (comp)
Download or read book Technical Reports of the National Highway Traffic Safety Administration; a Bibliography, 1977 written by L. Flynn (comp) and published by . This book was released on 1978 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Technical Reports of the National Highway Traffic Safety Administration by : Lois Flynn
Download or read book Technical Reports of the National Highway Traffic Safety Administration written by Lois Flynn and published by . This book was released on 1976 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis ERDA Energy Research Abstracts by : United States. Energy Research and Development Administration
Download or read book ERDA Energy Research Abstracts written by United States. Energy Research and Development Administration and published by . This book was released on 1977 with total page 906 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Public Roads written by and published by . This book was released on 1974 with total page 562 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Energy Research Abstracts written by and published by . This book was released on 1993 with total page 654 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Resources in Education written by and published by . This book was released on 1976 with total page 852 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis A Subject Bibliography from Highway Safety Literature by : United States. National Highway Traffic Safety Administration
Download or read book A Subject Bibliography from Highway Safety Literature written by United States. National Highway Traffic Safety Administration and published by . This book was released on 1977 with total page 494 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Research in Education written by and published by . This book was released on 1970 with total page 770 pages. Available in PDF, EPUB and Kindle. Book excerpt:
