Large Simple Trials And Knowledge Generation In A Learning Health System
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Large Simple Trials And Knowledge Generation In A Learning Health System
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2013-12-05
Large Simple Trials And Knowledge Generation In A Learning Health System written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-12-05 with Medical categories.
Randomized clinical trials (RCTs) are often referred to as the "gold standard" of clinical research. However, in its current state, the U.S. clinical trials enterprise faces substantial challenges to the efficient and effective conduct of research. Streamlined approaches to RCTs, such as large simple trials (LSTs), may provide opportunities for progress on these challenges. Clinical trials support the development of new medical products and the evaluation of existing products by generating knowledge about safety and efficacy in pre- and post-marketing settings and serve to inform medical decision making and medical product development. Although well-designed and -implemented clinical trials can provide robust evidence, a gap exists between the evidence needs of a continuously learning health system, in which all medical decisions are based on the best available evidence, and the reality, in which the generation of timely and practical evidence faces significant barriers. Large Simple Trials and Knowledge Generation in a Learning Health System is the summary of a workshop convened by the Institute of Medicine's Roundtable on Value & Science-Driven Health Care and the Forum on Drug Discovery, Development, and Translation. Experts from a wide range of disciplines-including health information technology, research funding, clinical research methods, statistics, patients, product development, medical product regulation, and clinical outcomes research-met to marshal a better understanding of the issues, options, and approaches to accelerating the use of LSTs. This publication summarizes discussions on the potential of LSTs to improve the speed and practicality of knowledge generation for medical decision making and medical product development, including efficacy and effectiveness assessments, in a continuously learning health system. Large Simple Trials and Knowledge Generation in a Learning Health System explores acceleration of the use of LSTs to improve the speed and practicality of knowledge generation for medical decision making and medical product development; considers the concepts of LST design, examples of successful LSTs, the relative advantages of LSTs, and the infrastructure needed to build LST capacity as a routine function of care; identifies structural, cultural, and regulatory barriers hindering the development of an enhanced LST capacity; discusses needs and strategies in building public demand for and participation in LSTs; and considers near-term strategies for accelerating progress in the uptake of LSTs in the United States.
Large Simple Trials And Knowledge Generation In A Learning Health System
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Author : Roundtable on Value and Science-Driven Health Care
language : en
Publisher:
Release Date : 2013
Large Simple Trials And Knowledge Generation In A Learning Health System written by Roundtable on Value and Science-Driven Health Care and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013 with categories.
Annotation. Randomized clinical trials (RCTs) are often referred to as the "gold standard" of clinical research. However, in its current state, the U.S. clinical trials enterprise faces substantial challenges to the efficient and effective conduct of research. Streamlined approaches to RCTs, such as large simple trials (LSTs), may provide opportunities for progress on these challenges. Clinical trials support the development of new medical products and the evaluation of existing products by generating knowledge about safety and efficacy in pre- and post-marketing settings and serve to inform medical decision making and medical product development. Although well-designed and -implemented clinical trials can provide robust evidence, a gap exists between the evidence needs of a continuously learning health system, in which all medical decisions are based on the best available evidence, and the reality, in which the generation of timely and practical evidence faces significant barriers."Large Simple Trials and Knowledge Generation in a Learning Health System" is the summary of a workshop convened by the Institute of Medicine's Roundtable on Value considers the concepts of 1st design, examples of successful LSTs, the relative advantages of LSTs, and the infrastructure needed to build 1st capacity as a routine function of care; identifies structural, cultural, and regulatory barriers hindering the development of an enhanced 1st capacity; discusses needs and strategies in building public demand for and participation in LSTs; and considers near-term strategies for accelerating progress in the uptake of LSTs in the United States.
Real World Evidence Generation And Evaluation Of Therapeutics
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2017-07-05
Real World Evidence Generation And Evaluation Of Therapeutics written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-07-05 with Medical categories.
The volume and complexity of information about individual patients is greatly increasing with use of electronic records and personal devices. Potential effects on medical product development in the context of this wealth of real-world data could be numerous and varied, ranging from the ability to determine both large-scale and patient-specific effects of treatments to the ability to assess how therapeutics affect patients' lives through measurement of lifestyle changes. In October 2016, the National Academies of Sciences, Engineering, and Medicine held a workshop to facilitate dialogue among stakeholders about the opportunities and challenges for incorporating real-world evidence into all stages in the process for the generation and evaluation of therapeutics. Participants explored unmet stakeholder needs and opportunities to generate new kinds of evidence that meet those needs. This publication summarizes the presentations and discussions from the workshop.
Fundamentals Of Drug Development
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Author : Jeffrey S. Barrett
language : en
Publisher: John Wiley & Sons
Release Date : 2022-09-07
Fundamentals Of Drug Development written by Jeffrey S. Barrett and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-09-07 with Medical categories.
Fundamentals of DRUG DEVELOPMENT Enables readers to understand the process of pharmaceutical research, its regulatory basis, and how it fits into the global healthcare environment This book discusses how to conduct pharmaceutical research and the context for how the industry fits into global healthcare. Holistically, the well-qualified author helps readers and students of drug development appreciate the time and expense of the process. Specifically, the work identifies the emerging trends shaping the future of drug development, along with important related topics like generic drugs, data sharing, and collaboration. To aid in seamless reader comprehension, the book includes a glossary of terms and a self-assessment quiz for each chapter at the end. PowerPoint slides are also available as an online ancillary for adopting professors. Sample topics covered in the book include: Drug development and its phases Decision-making processes, drug development milestones, and compound progression metrics The various disciplines involved along with an assessment of the complexity and risks associated across the stages of development Differences in the nature and scope of development programs due to the therapeutic area of interest Associated costs and resources required Graduate students and professors teaching courses in drug development, drug discovery, pharmaceuticals, medicinal chemistry, and drug synthesis will be able to use this book as a complete resource for understanding all the complexities and nuances involved in the drug development process.
Big Data Enabled Nursing
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Author : Connie W. Delaney
language : en
Publisher: Springer
Release Date : 2017-11-02
Big Data Enabled Nursing written by Connie W. Delaney and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-11-02 with Medical categories.
Historically, nursing, in all of its missions of research/scholarship, education and practice, has not had access to large patient databases. Nursing consequently adopted qualitative methodologies with small sample sizes, clinical trials and lab research. Historically, large data methods were limited to traditional biostatical analyses. In the United States, large payer data has been amassed and structures/organizations have been created to welcome scientists to explore these large data to advance knowledge discovery. Health systems electronic health records (EHRs) have now matured to generate massive databases with longitudinal trending. This text reflects how the learning health system infrastructure is maturing, and being advanced by health information exchanges (HIEs) with multiple organizations blending their data, or enabling distributed computing. It educates the readers on the evolution of knowledge discovery methods that span qualitative as well as quantitative data mining, including the expanse of data visualization capacities, are enabling sophisticated discovery. New opportunities for nursing and call for new skills in research methodologies are being further enabled by new partnerships spanning all sectors.
Pain Palliative Care An Issue Of Anesthesiology Clinics E Book
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Author : Ronald G. Pearl
language : en
Publisher: Elsevier Health Sciences
Release Date : 2023-05-30
Pain Palliative Care An Issue Of Anesthesiology Clinics E Book written by Ronald G. Pearl and has been published by Elsevier Health Sciences this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-05-30 with Medical categories.
In this issue of Anesthesiology Clinics, guest editors Drs. Ronald G. Pearl and Sean Mackey bring their considerable expertise to the topic of Pain/Palliative Care. Top experts in the field cover key topics such as psychological approaches for migraine management; ketamine in chronic pain management; spinal cord stimulation for treatment of chronic pain: history and transition to novel waveforms; blinded pain cocktails; transitional pain services; and more. Contains 11 relevant, practice-oriented topics including the emerging field of potential biased opioid agonists; update on treatments for facial pain; disparities in pain medicine; ultrasound-guided procedures in the management of chronic pain; and more. Provides in-depth clinical reviews on pain and palliative care, offering actionable insights for clinical practice. Presents the latest information on this timely, focused topic under the leadership of experienced editors in the field. Authors synthesize and distill the latest research and practice guidelines to create clinically significant, topic-based reviews.
Opportunities For Organ Donor Intervention Research
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2018-01-21
Opportunities For Organ Donor Intervention Research written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-01-21 with Medical categories.
The organ donation and transplantation system strives to honor the gift of donated organs by fully using those organs to save and improve the quality of the lives of their recipients. However, there are not enough donated organs to meet the demand and some donated organs may not be recovered, some recovered organs may not be transplanted, and some transplanted organs may not function adequately. Organ donor intervention research can test and assess interventions (e.g., medications, devices, and donor management protocols) to maintain or improve organ quality prior to, during, and following transplantation. The intervention is administered either while the organ is still in the deceased donor or after it is recovered from the donor but before it is transplanted into a recipient. Organ donor intervention research presents new challenges to the organ donation and transplantation community because of ethical questions about who should be considered a human subject in a research study, whose permission and oversight are needed, and how to ensure that such research does not threaten the equitable distribution of a scarce and valuable resource. Opportunities for Organ Donor Intervention Research focuses on the ethical, legal, regulatory, policy, and organizational issues relevant to the conduct of research in the United States involving deceased organ donors. This report provides recommendations for how to conduct organ donor intervention research in a manner that maintains high ethical standards, that ensures dignity and respect for deceased organ donors and their families, that provides transparency and information for transplant candidates who might receive a research organ, and that supports and sustains the public's trust in the process of organ donation and transplantation.
Next Generation Interstitial Lung Disease An Issue Of Clinics In Chest Medicine Ebook
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Author : Harold R Collard
language : en
Publisher: Elsevier Health Sciences
Release Date : 2021-06-03
Next Generation Interstitial Lung Disease An Issue Of Clinics In Chest Medicine Ebook written by Harold R Collard and has been published by Elsevier Health Sciences this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-06-03 with Medical categories.
In this issue of Clinics in Chest Medicine, Guest Editors Harold R Collard, Luca Richeldi, and Kerri A. Johannson bring their considerable expertise to the topic of Next-generation Interstitial Lung Disease. Provides concise and comprehensive coverage of the issues physicians face every day. Presents the latest information on a timely, focused topic under the leadership of experienced editors in the field.
The Learning Healthcare System
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2007-06-01
The Learning Healthcare System written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007-06-01 with Medical categories.
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.
Observational Studies In A Learning Health System
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Author : A Learning Health System Activity
language : en
Publisher: National Academies Press
Release Date : 2013-12-16
Observational Studies In A Learning Health System written by A Learning Health System Activity and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-12-16 with Medical categories.
Clinical research strains to keep up with the rapid and iterative evolution of medical interventions, clinical practice innovation, and the increasing demand for information on the clinical effectiveness of these advancements. In response to the growing availability of archived and real-time digital health data and the opportunities this data provides for research, as well as the increasing number of studies using prospectively collected clinical data, the Institute of Medicine\'s Roundtable on Value & Science-Driven Health Care convened a workshop on Observational Studies in a Learning Health System. Participants, including experts from a wide range of disciplines - clinical researchers, statisticians, biostatisticians, epidemiologists, health care informaticians, health care analytics, research funders, health products industry, clinicians, payers, and regulators - explored leading edge approaches to observational studies, charted a course for the use of the growing health data utility, and identified opportunities to advance progress. Workshop speakers and individual participants strove to identify stakeholder needs and barriers to the broader application of observational studies. Observational Studies in a Learning Health Systemis the summary of the workshop. This report explores the role of observational studies in the generation of evidence to guide clinical and health policy decisions. The report discusses concepts of rigorous observational study design and analysis, emerging statistical methods, and opportunities and challenges of observational studies to complement evidence from experimental methods, treatment heterogeneity, and effectiveness estimates tailored toward individual patients.