Sharing Clinical Research Data

Sharing Clinical Research Data PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309268745
Category : Medical
Languages : en
Pages : 157

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Book Description
Pharmaceutical companies, academic researchers, and government agencies such as the Food and Drug Administration and the National Institutes of Health all possess large quantities of clinical research data. If these data were shared more widely within and across sectors, the resulting research advances derived from data pooling and analysis could improve public health, enhance patient safety, and spur drug development. Data sharing can also increase public trust in clinical trials and conclusions derived from them by lending transparency to the clinical research process. Much of this information, however, is never shared. Retention of clinical research data by investigators and within organizations may represent lost opportunities in biomedical research. Despite the potential benefits that could be accrued from pooling and analysis of shared data, barriers to data sharing faced by researchers in industry include concerns about data mining, erroneous secondary analyses of data, and unwarranted litigation, as well as a desire to protect confidential commercial information. Academic partners face significant cultural barriers to sharing data and participating in longer term collaborative efforts that stem from a desire to protect intellectual autonomy and a career advancement system built on priority of publication and citation requirements. Some barriers, like the need to protect patient privacy, pre- sent challenges for both sectors. Looking ahead, there are also a number of technical challenges to be faced in analyzing potentially large and heterogeneous datasets. This public workshop focused on strategies to facilitate sharing of clinical research data in order to advance scientific knowledge and public health. While the workshop focused on sharing of data from preplanned interventional studies of human subjects, models and projects involving sharing of other clinical data types were considered to the extent that they provided lessons learned and best practices. The workshop objectives were to examine the benefits of sharing of clinical research data from all sectors and among these sectors, including, for example: benefits to the research and development enterprise and benefits to the analysis of safety and efficacy. Sharing Clinical Research Data: Workshop Summary identifies barriers and challenges to sharing clinical research data, explores strategies to address these barriers and challenges, including identifying priority actions and "low-hanging fruit" opportunities, and discusses strategies for using these potentially large datasets to facilitate scientific and public health advances.

Sharing Clinical Research Data

Sharing Clinical Research Data PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309268745
Category : Medical
Languages : en
Pages : 157

Get Book Here

Book Description
Pharmaceutical companies, academic researchers, and government agencies such as the Food and Drug Administration and the National Institutes of Health all possess large quantities of clinical research data. If these data were shared more widely within and across sectors, the resulting research advances derived from data pooling and analysis could improve public health, enhance patient safety, and spur drug development. Data sharing can also increase public trust in clinical trials and conclusions derived from them by lending transparency to the clinical research process. Much of this information, however, is never shared. Retention of clinical research data by investigators and within organizations may represent lost opportunities in biomedical research. Despite the potential benefits that could be accrued from pooling and analysis of shared data, barriers to data sharing faced by researchers in industry include concerns about data mining, erroneous secondary analyses of data, and unwarranted litigation, as well as a desire to protect confidential commercial information. Academic partners face significant cultural barriers to sharing data and participating in longer term collaborative efforts that stem from a desire to protect intellectual autonomy and a career advancement system built on priority of publication and citation requirements. Some barriers, like the need to protect patient privacy, pre- sent challenges for both sectors. Looking ahead, there are also a number of technical challenges to be faced in analyzing potentially large and heterogeneous datasets. This public workshop focused on strategies to facilitate sharing of clinical research data in order to advance scientific knowledge and public health. While the workshop focused on sharing of data from preplanned interventional studies of human subjects, models and projects involving sharing of other clinical data types were considered to the extent that they provided lessons learned and best practices. The workshop objectives were to examine the benefits of sharing of clinical research data from all sectors and among these sectors, including, for example: benefits to the research and development enterprise and benefits to the analysis of safety and efficacy. Sharing Clinical Research Data: Workshop Summary identifies barriers and challenges to sharing clinical research data, explores strategies to address these barriers and challenges, including identifying priority actions and "low-hanging fruit" opportunities, and discusses strategies for using these potentially large datasets to facilitate scientific and public health advances.

Standardization Essentials

Standardization Essentials PDF Author: Steven M. Spivak
Publisher: CRC Press
ISBN: 1482277387
Category : Technology & Engineering
Languages : en
Pages : 431

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Book Description
This ready reference surveys the discipline of standards and standardization, defining common terms, clarifying descriptions, describing how standards could be used to restrain trade, and explaining how international trade is stimulated by the due process provisions of standards writing organizations. Containing real-world examples provided by experienced standards professionals, Standardization Essentials is a vital, forward-looking reference for mechanical, civil, electrical and electronics, materials, chemical, mineral, cost, quality, reliability, industrial, developmental, safety, forensic, and consulting engineers; standards managers; architects; project managers; upper-level undergraduate, graduate, and continuing education students in these disciplines. Crystallizes the essential role that standards play in strategic standardization management, purchasing, contractual agreements, and international trade! Covering costs, benefits, limitations, uses, and abuses of standardization programs, Standardization Essentials Considers whether standards build or bar trade and the use of international standards to leverage world markets Presents a case study of conformity assessment related to international technical trade barriers Focuses on consumer safety standards for automobile tires and other products Addresses implementation of ISO 9000 and ISO 14000 management system standards in industry Highlights voluntary (nongovernmental) and mandatory (governmental) standards and regulations developed by a variety of organizations Reveals competition, incongruities, and harmonization among national and international standards

Benefits of Standardization

Benefits of Standardization PDF Author:
Publisher:
ISBN:
Category : Evaluation
Languages : en
Pages : 154

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Book Description


Build-to-order & Mass Customization

Build-to-order & Mass Customization PDF Author: David M. Anderson
Publisher:
ISBN: 9781878072306
Category : Business logistics
Languages : en
Pages : 526

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Book Description


Advances in Human Factors and Ergonomics in Healthcare and Medical Devices

Advances in Human Factors and Ergonomics in Healthcare and Medical Devices PDF Author: Jay Kalra
Publisher: Springer
ISBN: 9783030807436
Category : Technology & Engineering
Languages : en
Pages : 0

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Book Description
This book is concerned with human factors and ergonomics research and developments in the design and use of systems and devices for effective and safe healthcare delivery. It reports on approaches for improving healthcare devices so that they better fit to people’s, including special population’s needs. It also covers assistive devices aimed at reducing occupational risks of health professionals as well as innovative strategies for error reduction, and more effective training and education methods for healthcare workers and professionals. Equal emphasis is given to digital technologies and to physical, cognitive and organizational aspects, which are considered in an integrated manner, so as to facilitate a systemic approach for improving the quality and safety of healthcare service. The book also includes a special section dedicated to innovative strategies for assisting caregivers’, patients’, and people’s needs during pandemic. Based on papers presented at the AHFE 2021 Conference on Human Factors and Ergonomics in Healthcare and Medical Devices, held virtually on 25–29 July, 2021, from USA, the book offers a timely reference guide to both researchers and healthcare professionals involved in the design of medical systems and managing healthcare settings, as well as to healthcare counselors and global health organizations.

Standardization is Good Business

Standardization is Good Business PDF Author: Royce P. Preston
Publisher:
ISBN:
Category : Standardization
Languages : en
Pages : 27

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Book Description


Standardization: A Business Approach to the Role of National Standardization Organizations

Standardization: A Business Approach to the Role of National Standardization Organizations PDF Author: Henk J. de Vries
Publisher: Springer Science & Business Media
ISBN: 147573042X
Category : Business & Economics
Languages : en
Pages : 330

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Book Description
This study fills a gap in standardization literature. It is the first academic analysis of national standardization organizations. These organizations exist in every country and may be private or governmental organizations. The first national standardization th organizations were founded in the early decades of the 20 century and were aimed at rationalizing industrial production. Their mode of operation reflects the sense of co operation at the national level and - in the telecommunications and electrotechnical field - at the intemationallevel as well. Now, however, the scene has changed, with companies operating internationally. Standards for products, processes, and services are crucial factors in determining success or failure on a fiercely competitive market, especially when functional compatibility is a prerequisite, as is the case in computer and telecommunications technologies. As a consequence, rather homogeneous needs of participants in standardization have given way to conflicting interests. This prompts a discussion about the traditional role of national standardization organizations. They increasingly depend on their exclusive links to the international standardization organizations ISO and IEC, and, in the case of Europe, the regional organizations CEN and CENELEC. In many cases, formal standardization organizations are not the obvious bodies for developing standards to meet business needs. Is this inevitable or could they improve performance and regain their market share? Henk de Vries answers this question against the background of current developments in standardization at the international, European, and national levels.

Shaping the Future Through Standardization

Shaping the Future Through Standardization PDF Author: Jakobs, Kai
Publisher: IGI Global
ISBN: 1799821838
Category : Computers
Languages : en
Pages : 345

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Book Description
Quality assurance is an essential aspect for ensuring the success of corporations worldwide. Consistent quality requirements across organizations of similar types ensure that these requirements can be accurately and easily evaluated. Shaping the Future Through Standardization is an essential scholarly book that examines quality and standardization within diverse organizations globally with a special focus on future perspectives, including how standards and standardization may shape the future. Featuring a wide range of topics such as economics, pedagogy, and management, this book is ideal for academicians, researchers, decision makers, policymakers, managers, corporate professionals, and students.

Registries for Evaluating Patient Outcomes

Registries for Evaluating Patient Outcomes PDF Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385

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Book Description
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.

The Spirit of Kaizen: Creating Lasting Excellence One Small Step at a Time

The Spirit of Kaizen: Creating Lasting Excellence One Small Step at a Time PDF Author: Robert Maurer
Publisher: McGraw Hill Professional
ISBN: 0071796185
Category : Business & Economics
Languages : en
Pages : 193

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Book Description
Discover the power of KAIZEN to make lasting and powerful change in your organization “Maurer uses his knowledge of the brain and human psychology to show what I have promoted for the past three decades—that continuous improvement is built on the foundation of people courageously using their creativity. Kaizen is much more than a world-class management practice; it is a technique to remove fear from our mind’s mind, enabling us to take small steps to better things. The process of change starts with awareness and desire in our minds and then leads to action and change in the physical world. Readers of this book will surely fi nd new ideas and encouragement to make improvements in personal health, performance at work, and their own well-being.” —Masaaki Imai, Chariman, Kaizen Institute KAIZEN: The Small-Step Step Solution for You and Your Company Today’s businesses love the idea of revolutionary, immediate change. But major “disruptive” efforts often fail because radical change sets off alarms in our brains and shuts down our power to think clearly and creatively. There is, however, a more effective path to change. Change that is lasting and powerful. Change that begins with one small step . . . It’s The Spirit of Kaizen—a proven system for implementing small, incremental steps that can have a big impact in reaching your goals. This step-by-step guide from renowned psychologist and consultant Dr. Robert Maurer shows you how to: Lower costs—by offering little rewards Raise quality—by reducing mistakes Manage difficult people— one step at a time Boost morale and productivity— in five minutes a day Implement big ideas—through small but steady actions Sell more—in less time Filled with practical tips and ready-to-use tools for managers, innovators, and entrepreneurs, The Spirit of Kaizen is the essential handbook for a changing world. You’ll learn how to think outside the suggestion box, remove mental blindfolds, manage stress with one-minute exercises, and handle rising health-care costs. You’ll discover the “small step” secrets for dealing with all kinds of people, from tough bosses and listless workers to stubborn clients and fussy customers. These simple but powerful techniques can be applied to almost any workplace situation, especially when you’re trying to navigate the stormy waters of radical change, high-pressure deadlines, and cutthroat competition. These are the same methods of small, continual improvement that have been tested by the largest companies, such as Boeing, Toyota, and the U.S. Navy—methods that will work for you, too. No matter how big the obstacle or how big the dream, The Spirit of Kaizen has a small-step solution to help you succeed.