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.

Download or read book Guide to Implementing the Next Generation Science Standards written by National Research Council and published by National Academies Press. This book was released on 2015-03-27 with total page 190 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Framework for K-12 Science Education and Next Generation Science Standards (NGSS) describe a new vision for science learning and teaching that is catalyzing improvements in science classrooms across the United States. Achieving this new vision will require time, resources, and ongoing commitment from state, district, and school leaders, as well as classroom teachers. Successful implementation of the NGSS will ensure that all K-12 students have high-quality opportunities to learn science. Guide to Implementing the Next Generation Science Standards provides guidance to district and school leaders and teachers charged with developing a plan and implementing the NGSS as they change their curriculum, instruction, professional learning, policies, and assessment to align with the new standards. For each of these elements, this report lays out recommendations for action around key issues and cautions about potential pitfalls. Coordinating changes in these aspects of the education system is challenging. As a foundation for that process, Guide to Implementing the Next Generation Science Standards identifies some overarching principles that should guide the planning and implementation process. The new standards present a vision of science and engineering learning designed to bring these subjects alive for all students, emphasizing the satisfaction of pursuing compelling questions and the joy of discovery and invention. Achieving this vision in all science classrooms will be a major undertaking and will require changes to many aspects of science education. Guide to Implementing the Next Generation Science Standards will be a valuable resource for states, districts, and schools charged with planning and implementing changes, to help them achieve the goal of teaching science for the 21st century.

Download or read book Large Scale Biomedical Science written by National Research Council and published by National Academies Press. This book was released on 2003-07-19 with total page 297 pages. Available in PDF, EPUB and Kindle. Book excerpt: The nature of biomedical research has been evolving in recent years. Technological advances that make it easier to study the vast complexity of biological systems have led to the initiation of projects with a larger scale and scope. In many cases, these large-scale analyses may be the most efficient and effective way to extract functional information from complex biological systems. Large-Scale Biomedical Science: Exploring Strategies for Research looks at the role of these new large-scale projects in the biomedical sciences. Though written by the National Academies' Cancer Policy Board, this book addresses implications of large-scale science extending far beyond cancer research. It also identifies obstacles to the implementation of these projects, and makes recommendations to improve the process. The ultimate goal of biomedical research is to advance knowledge and provide useful innovations to society. Determining the best and most efficient method for accomplishing that goal, however, is a continuing and evolving challenge. The recommendations presented in Large-Scale Biomedical Science are intended to facilitate a more open, inclusive, and accountable approach to large-scale biomedical research, which in turn will maximize progress in understanding and controlling human disease.

Download or read book Beyond the HIPAA Privacy Rule written by Institute of Medicine and published by National Academies Press. This book was released on 2009-03-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.

Download or read book Exposure Science in the 21st Century written by National Research Council and published by National Academies Press. This book was released on 2012-10-28 with total page 210 pages. Available in PDF, EPUB and Kindle. Book excerpt: From the use of personal products to our consumption of food, water, and air, people are exposed to a wide array of agents each day-many with the potential to affect health. Exposure Science in the 21st Century: A Vision and A Strategy investigates the contact of humans or other organisms with those agents (that is, chemical, physical, and biologic stressors) and their fate in living systems. The concept of exposure science has been instrumental in helping us understand how stressors affect human and ecosystem health, and in efforts to prevent or reduce contact with harmful stressors. In this way exposure science has played an integral role in many areas of environmental health, and can help meet growing needs in environmental regulation, urban and ecosystem planning, and disaster management. Exposure Science in the 21st Century: A Vision and A Strategy explains that there are increasing demands for exposure science information, for example to meet needs for data on the thousands of chemicals introduced into the market each year, and to better understand the health effects of prolonged low-level exposure to stressors. Recent advances in tools and technologies-including sensor systems, analytic methods, molecular technologies, computational tools, and bioinformatics-have provided the potential for more accurate and comprehensive exposure science data than ever before. This report also provides a roadmap to take advantage of the technologic innovations and strategic collaborations to move exposure science into the future.

Download or read book The Prevention and Treatment of Missing Data in Clinical Trials written by National Research Council and published by National Academies Press. This book was released on 2010-12-21 with total page 163 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.

Download or read book Toxicity Testing in the 21st Century written by National Research Council and published by National Academies Press. This book was released on 2007-10-05 with total page 217 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advances in molecular biology and toxicology are paving the way for major improvements in the evaluation of the hazards posed by the large number of chemicals found at low levels in the environment. The National Research Council was asked by the U.S. Environmental Protection Agency to review the state of the science and create a far-reaching vision for the future of toxicity testing. The book finds that developing, improving, and validating new laboratory tools based on recent scientific advances could significantly improve our ability to understand the hazards and risks posed by chemicals. This new knowledge would lead to much more informed environmental regulations and dramatically reduce the need for animal testing because the new tests would be based on human cells and cell components. Substantial scientific efforts and resources will be required to leverage these new technologies to realize the vision, but the result will be a more efficient, informative and less costly system for assessing the hazards posed by industrial chemicals and pesticides.

Download or read book Clinical Practice Guidelines We Can Trust written by Institute of Medicine and published by National Academies Press. This book was released on 2011-06-16 with total page 217 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advances in medical, biomedical and health services research have reduced the level of uncertainty in clinical practice. Clinical practice guidelines (CPGs) complement this progress by establishing standards of care backed by strong scientific evidence. CPGs are statements that include recommendations intended to optimize patient care. These statements are informed by a systematic review of evidence and an assessment of the benefits and costs of alternative care options. Clinical Practice Guidelines We Can Trust examines the current state of clinical practice guidelines and how they can be improved to enhance healthcare quality and patient outcomes. Clinical practice guidelines now are ubiquitous in our healthcare system. The Guidelines International Network (GIN) database currently lists more than 3,700 guidelines from 39 countries. Developing guidelines presents a number of challenges including lack of transparent methodological practices, difficulty reconciling conflicting guidelines, and conflicts of interest. Clinical Practice Guidelines We Can Trust explores questions surrounding the quality of CPG development processes and the establishment of standards. It proposes eight standards for developing trustworthy clinical practice guidelines emphasizing transparency; management of conflict of interest ; systematic review-guideline development intersection; establishing evidence foundations for and rating strength of guideline recommendations; articulation of recommendations; external review; and updating. Clinical Practice Guidelines We Can Trust shows how clinical practice guidelines can enhance clinician and patient decision-making by translating complex scientific research findings into recommendations for clinical practice that are relevant to the individual patient encounter, instead of implementing a one size fits all approach to patient care. This book contains information directly related to the work of the Agency for Healthcare Research and Quality (AHRQ), as well as various Congressional staff and policymakers. It is a vital resource for medical specialty societies, disease advocacy groups, health professionals, private and international organizations that develop or use clinical practice guidelines, consumers, clinicians, and payers.

Download or read book Enhancing the Effectiveness of Team Science written by National Research Council and published by National Academies Press. This book was released on 2015-07-15 with total page 255 pages. Available in PDF, EPUB and Kindle. Book excerpt: The past half-century has witnessed a dramatic increase in the scale and complexity of scientific research. The growing scale of science has been accompanied by a shift toward collaborative research, referred to as "team science." Scientific research is increasingly conducted by small teams and larger groups rather than individual investigators, but the challenges of collaboration can slow these teams' progress in achieving their scientific goals. How does a team-based approach work, and how can universities and research institutions support teams? Enhancing the Effectiveness of Team Science synthesizes and integrates the available research to provide guidance on assembling the science team; leadership, education and professional development for science teams and groups. It also examines institutional and organizational structures and policies to support science teams and identifies areas where further research is needed to help science teams and groups achieve their scientific and translational goals. This report offers major public policy recommendations for science research agencies and policymakers, as well as recommendations for individual scientists, disciplinary associations, and research universities. Enhancing the Effectiveness of Team Science will be of interest to university research administrators, team science leaders, science faculty, and graduate and postdoctoral students.

Download or read book Inquiry and the National Science Education Standards written by National Research Council and published by National Academies Press. This book was released on 2000-05-03 with total page 223 pages. Available in PDF, EPUB and Kindle. Book excerpt: Humans, especially children, are naturally curious. Yet, people often balk at the thought of learning scienceâ€"the "eyes glazed over" syndrome. Teachers may find teaching science a major challenge in an era when science ranges from the hardly imaginable quark to the distant, blazing quasar. Inquiry and the National Science Education Standards is the book that educators have been waiting forâ€"a practical guide to teaching inquiry and teaching through inquiry, as recommended by the National Science Education Standards. This will be an important resource for educators who must help school boards, parents, and teachers understand "why we can't teach the way we used to." "Inquiry" refers to the diverse ways in which scientists study the natural world and in which students grasp science knowledge and the methods by which that knowledge is produced. This book explains and illustrates how inquiry helps students learn science content, master how to do science, and understand the nature of science. This book explores the dimensions of teaching and learning science as inquiry for K-12 students across a range of science topics. Detailed examples help clarify when teachers should use the inquiry-based approach and how much structure, guidance, and coaching they should provide. The book dispels myths that may have discouraged educators from the inquiry-based approach and illuminates the subtle interplay between concepts, processes, and science as it is experienced in the classroom. Inquiry and the National Science Education Standards shows how to bring the standards to life, with features such as classroom vignettes exploring different kinds of inquiries for elementary, middle, and high school and Frequently Asked Questions for teachers, responding to common concerns such as obtaining teaching supplies. Turning to assessment, the committee discusses why assessment is important, looks at existing schemes and formats, and addresses how to involve students in assessing their own learning achievements. In addition, this book discusses administrative assistance, communication with parents, appropriate teacher evaluation, and other avenues to promoting and supporting this new teaching paradigm.

Download or read book Improving Healthcare Quality in Europe Characteristics Effectiveness and Implementation of Different Strategies written by OECD and published by OECD Publishing. This book was released on 2019-10-17 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume, developed by the Observatory together with OECD, provides an overall conceptual framework for understanding and applying strategies aimed at improving quality of care. Crucially, it summarizes available evidence on different quality strategies and provides recommendations for their implementation. This book is intended to help policy-makers to understand concepts of quality and to support them to evaluate single strategies and combinations of strategies.

Download or read book Scientific Research in Education written by National Research Council and published by National Academies Press. This book was released on 2002-03-28 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt: Researchers, historians, and philosophers of science have debated the nature of scientific research in education for more than 100 years. Recent enthusiasm for "evidence-based" policy and practice in educationâ€"now codified in the federal law that authorizes the bulk of elementary and secondary education programsâ€"have brought a new sense of urgency to understanding the ways in which the basic tenets of science manifest in the study of teaching, learning, and schooling. Scientific Research in Education describes the similarities and differences between scientific inquiry in education and scientific inquiry in other fields and disciplines and provides a number of examples to illustrate these ideas. Its main argument is that all scientific endeavors share a common set of principles, and that each fieldâ€"including education researchâ€"develops a specialization that accounts for the particulars of what is being studied. The book also provides suggestions for how the federal government can best support high-quality scientific research in education.

Download or read book Communicating Science Effectively written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-03-08 with total page 153 pages. Available in PDF, EPUB and Kindle. Book excerpt: Science and technology are embedded in virtually every aspect of modern life. As a result, people face an increasing need to integrate information from science with their personal values and other considerations as they make important life decisions about medical care, the safety of foods, what to do about climate change, and many other issues. Communicating science effectively, however, is a complex task and an acquired skill. Moreover, the approaches to communicating science that will be most effective for specific audiences and circumstances are not obvious. Fortunately, there is an expanding science base from diverse disciplines that can support science communicators in making these determinations. Communicating Science Effectively offers a research agenda for science communicators and researchers seeking to apply this research and fill gaps in knowledge about how to communicate effectively about science, focusing in particular on issues that are contentious in the public sphere. To inform this research agenda, this publication identifies important influences â€" psychological, economic, political, social, cultural, and media-related â€" on how science related to such issues is understood, perceived, and used.

Download or read book Strengthening Forensic Science in the United States written by National Research Council and published by National Academies Press. This book was released on 2009-07-29 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: Scores of talented and dedicated people serve the forensic science community, performing vitally important work. However, they are often constrained by lack of adequate resources, sound policies, and national support. It is clear that change and advancements, both systematic and scientific, are needed in a number of forensic science disciplines to ensure the reliability of work, establish enforceable standards, and promote best practices with consistent application. Strengthening Forensic Science in the United States: A Path Forward provides a detailed plan for addressing these needs and suggests the creation of a new government entity, the National Institute of Forensic Science, to establish and enforce standards within the forensic science community. The benefits of improving and regulating the forensic science disciplines are clear: assisting law enforcement officials, enhancing homeland security, and reducing the risk of wrongful conviction and exoneration. Strengthening Forensic Science in the United States gives a full account of what is needed to advance the forensic science disciplines, including upgrading of systems and organizational structures, better training, widespread adoption of uniform and enforceable best practices, and mandatory certification and accreditation programs. While this book provides an essential call-to-action for congress and policy makers, it also serves as a vital tool for law enforcement agencies, criminal prosecutors and attorneys, and forensic science educators.

Download or read book Guide for the Care and Use of Laboratory Animals written by National Research Council and published by National Academies Press. This book was released on 2011-01-27 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: A respected resource for decades, the Guide for the Care and Use of Laboratory Animals has been updated by a committee of experts, taking into consideration input from the scientific and laboratory animal communities and the public at large. The Guide incorporates new scientific information on common laboratory animals, including aquatic species, and includes extensive references. It is organized around major components of animal use: Key concepts of animal care and use. The Guide sets the framework for the humane care and use of laboratory animals. Animal care and use program. The Guide discusses the concept of a broad Program of Animal Care and Use, including roles and responsibilities of the Institutional Official, Attending Veterinarian and the Institutional Animal Care and Use Committee. Animal environment, husbandry, and management. A chapter on this topic is now divided into sections on terrestrial and aquatic animals and provides recommendations for housing and environment, husbandry, behavioral and population management, and more. Veterinary care. The Guide discusses veterinary care and the responsibilities of the Attending Veterinarian. It includes recommendations on animal procurement and transportation, preventive medicine (including animal biosecurity), and clinical care and management. The Guide addresses distress and pain recognition and relief, and issues surrounding euthanasia. Physical plant. The Guide identifies design issues, providing construction guidelines for functional areas; considerations such as drainage, vibration and noise control, and environmental monitoring; and specialized facilities for animal housing and research needs. The Guide for the Care and Use of Laboratory Animals provides a framework for the judgments required in the management of animal facilities. This updated and expanded resource of proven value will be important to scientists and researchers, veterinarians, animal care personnel, facilities managers, institutional administrators, policy makers involved in research issues, and animal welfare advocates.

Download or read book Transforming Clinical Research in the United States written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-22 with total page 151 pages. Available in PDF, EPUB and Kindle. Book excerpt: An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.

Download or read book Priorities for Research to Reduce the Threat of Firearm Related Violence written by National Research Council and published by National Academies Press. This book was released on 2013-10-03 with total page 121 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 2010, more than 105,000 people were injured or killed in the United States as the result of a firearm-related incident. Recent, highly publicized, tragic mass shootings in Newtown, CT; Aurora, CO; Oak Creek, WI; and Tucson, AZ, have sharpened the American public's interest in protecting our children and communities from the harmful effects of firearm violence. While many Americans legally use firearms for a variety of activities, fatal and nonfatal firearm violence poses a serious threat to public safety and welfare. In January 2013, President Barack Obama issued 23 executive orders directing federal agencies to improve knowledge of the causes of firearm violence, what might help prevent it, and how to minimize its burden on public health. One of these orders directed the Centers for Disease Control and Prevention (CDC) to, along with other federal agencies, immediately begin identifying the most pressing problems in firearm violence research. The CDC and the CDC Foundation asked the IOM, in collaboration with the National Research Council, to convene a committee tasked with developing a potential research agenda that focuses on the causes of, possible interventions to, and strategies to minimize the burden of firearm-related violence. Priorities for Research to Reduce the Threat of Firearm-Related Violence focuses on the characteristics of firearm violence, risk and protective factors, interventions and strategies, the impact of gun safety technology, and the influence of video games and other media.