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The pharmaceutical industry is currently operating under a business model that is not sustainable for the future. Given the high costs associated with drug development, there is a vital need to reform this process in order to provide safe and effective drugs while still securing a profit. Re-Engineering Clinical Trials evaluates the trends and challenges associated with the current drug development process and presents solutions that integrate the use of modern communication technologies, innovations and novel enrichment designs. This book focuses on the need to simplify drug development and offers you well-established methodologies and best practices based on real-world experiences from expert authors across industry and academia. Written for all those involved in clinical research, development and clinical trial design, this book provides a unique and valuable resource for streamlining the process, containing costs and increasing drug safety and effectiveness. - Highlights the latest paradigm-shifts and innovation advances in clinical research - Offers easy-to-find best practice sections, lists of current literature and resources for further reading and useful solutions to day-to-day problems in current drug development - Discusses important topics such as safety profiling, data mining, site monitoring, change management, increasing development costs, key performance indicators and much more
This timely book addresses gaps in the understanding of how health information technology (IT) impacts on clinical workflows and how the effective implementation of these workflows are central to the safe and effective delivery of care to patients. It features clearly structured chapters covering a range of topics, including aspects of clinical workflows relevant to both practitioners and patients, tools for recording clinical workflow data techniques for potentially redesigning health IT enabled care coordination. Cognitive Informatics: Reengineering Clinical Workflow for More Efficient and Safer Care enables readers to develop a deeper understanding of clinical workflows and how these can potentially be modified to facilitate greater efficiency and safety in care provision, providing a valuable resource for both biomedical and health informatics professionals and trainees.
v. 1. Research findings -- v. 2. Concepts and methodology -- v. 3. Implementation issues -- v. 4. Programs, tools and products.
Winner of the Healthcare Information and Management Systems Society‘s (HIMSS) 2015 Book of the Year AwardGiven the on-going changes and challenges faced by today‘s health care organizations, Organizational and Process Reengineering Approaches for Health Care Transformation provides a practical, leader-led and team-based approach for reengineering o
As our nation enters a new era of medical science that offers the real prospect of personalized health care, we will be confronted by an increasingly complex array of health care options and decisions. The Learning Healthcare System considers how health care is structured to develop and to apply evidence-from health profession training and infrastructure development to advances in research methodology, patient engagement, payment schemes, and measurement-and highlights opportunities for the creation of a sustainable learning health care system that gets the right care to people when they need it and then captures the results for improvement. This book will be of primary interest to hospital and insurance industry administrators, health care providers, those who train and educate health workers, researchers, and policymakers. The Learning Healthcare System is the first in a series that will focus on issues important to improving the development and application of evidence in health care decision making. The Roundtable on Evidence-Based Medicine serves as a neutral venue for cooperative work among key stakeholders on several dimensions: to help transform the availability and use of the best evidence for the collaborative health care choices of each patient and provider; to drive the process of discovery as a natural outgrowth of patient care; and, ultimately, to ensure innovation, quality, safety, and value in health care.
Clinical Research Computing: A Practitioner's Handbook deals with the nuts-and-bolts of providing informatics and computing support for clinical research. The subjects that the practitioner must be aware of are not only technological and scientific, but also organizational and managerial. Therefore, the author offers case studies based on real life experiences in order to prepare the readers for the challenges they may face during their experiences either supporting clinical research or supporting electronic record systems. Clinical research computing is the application of computational methods to the broad field of clinical research. With the advent of modern digital computing, and the powerful data collection, storage, and analysis that is possible with it, it becomes more relevant to understand the technical details in order to fully seize its opportunities. - Offers case studies, based on real-life examples where possible, to engage the readers with more complex examples - Provides studies backed by technical details, e.g., schema diagrams, code snippets or algorithms illustrating particular techniques, to give the readers confidence to employ the techniques described in their own settings - Offers didactic content organization and an increasing complexity through the chapters
The Handbook of BioPharma Industry Acronyms & Terms is a comprehensive reference listing all terms and abbreviations used in the development and marketing of drugs.
The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.*Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government
A fundamental, reader-friendly guide to evidence-based practice (EBP) for BSN, MSN, and DNP nursing students, Evidence-Based Practice in Nursing explains the conceptual underpinnings of EBP and demonstrates how nurses can put EBP concepts into practice. Replete with critical knowledge, skills, tools, and scholarly development to enable nurses to fully and confidently deliver the highest-quality EBP care, this book eschews a one-size-fits-all approach unique systematic guidelines for understanding and applying EBP. Building blocks of information grow progressively more complex to apply to any point along nursing’s academic trajectory. Thoughtfully organized to fit a variety of EBP-related course objectives, Evidence Based Practice in Nursing easily adapts for standalone EBP courses at any level as well as advanced practice specialty courses that integrate EBP content. This book addresses the needs of all nursing instructors, including those who teach at multiple levels simultaneously. Key content discusses requisite conceptual knowledge of EBP for building clinical decision-making skills; conceptualizing, implementing, and evaluating EBP projects; conducting translational research and quality improvement for implementation and evaluation of EBP; developing leadership and structural empowerment strategies; and analyzing how students at each degree/level work with EBP independently, inter-professionally, and intraprofessionally. Chapters align with AACN essentials. Key Features: Follows a methodical systematic trajectory building from simple to complex concepts Includes abundant examples demonstrating both negative and positive EBP applications Enables instructors to adopt one textbook for BSN, MSN, and DNP students Includes practical design templates for developing EBP information plans with critical guideposts Provides a quality improvement toolkit, key words and concepts, illustrative tables, and figures