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 Experimentation with Human Subjects written by Paul Abraham Freund and published by George Braziller. This book was released on 1970 with total page 492 pages. Available in PDF, EPUB and Kindle. Book excerpt: Most of the essays appeared in the spring 1969 issue of Dædalus.
Download or read book Finding What Works in Health Care written by Institute of Medicine and published by National Academies Press. This book was released on 2011-07-20 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthcare decision makers in search of reliable information that compares health interventions increasingly turn to systematic reviews for the best summary of the evidence. Systematic reviews identify, select, assess, and synthesize the findings of similar but separate studies, and can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services. Systematic reviews can be helpful for clinicians who want to integrate research findings into their daily practices, for patients to make well-informed choices about their own care, for professional medical societies and other organizations that develop clinical practice guidelines. Too often systematic reviews are of uncertain or poor quality. There are no universally accepted standards for developing systematic reviews leading to variability in how conflicts of interest and biases are handled, how evidence is appraised, and the overall scientific rigor of the process. In Finding What Works in Health Care the Institute of Medicine (IOM) recommends 21 standards for developing high-quality systematic reviews of comparative effectiveness research. The standards address the entire systematic review process from the initial steps of formulating the topic and building the review team to producing a detailed final report that synthesizes what the evidence shows and where knowledge gaps remain. Finding What Works in Health Care also proposes a framework for improving the quality of the science underpinning systematic reviews. This book will serve as a vital resource for both sponsors and producers of systematic reviews of comparative effectiveness research.
Download or read book National Library of Medicine Current Catalog written by National Library of Medicine (U.S.) and published by . This book was released on 1965 with total page 1042 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Current Catalog written by National Library of Medicine (U.S.) and published by . This book was released on 1979 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: First multi-year cumulation covers six years: 1965-70.
Download or read book Ethical Considerations for Research Involving Prisoners written by Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research and published by National Academies Press. This book was released on 2007-01-22 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the past 30 years, the population of prisoners in the United States has expanded almost 5-fold, correctional facilities are increasingly overcrowded, and more of the country's disadvantaged populations—racial minorities, women, people with mental illness, and people with communicable diseases such as HIV/AIDS, hepatitis C, and tuberculosis—are under correctional supervision. Because prisoners face restrictions on liberty and autonomy, have limited privacy, and often receive inadequate health care, they require specific protections when involved in research, particularly in today's correctional settings. Given these issues, the Department of Health and Human Services' Office for Human Research Protections commissioned the Institute of Medicine to review the ethical considerations regarding research involving prisoners. The resulting analysis contained in this book, Ethical Considerations for Research Involving Prisoners, emphasizes five broad actions to provide prisoners involved in research with critically important protections: • expand the definition of "prisoner"; • ensure universally and consistently applied standards of protection; • shift from a category-based to a risk-benefit approach to research review; • update the ethical framework to include collaborative responsibility; and • enhance systematic oversight of research involving prisoners.
Download or read book Medical Technology Assessment Directory written by Institute of Medicine and published by National Academies Press. This book was released on 1988-02-01 with total page 709 pages. Available in PDF, EPUB and Kindle. Book excerpt: For the first time, a single reference identifies medical technology assessment programs. A valuable guide to the field, this directory contains more than 60 profiles of programs that conduct and report on medical technology assessments. Each profile includes a listing of report citations for that program, and all the reports are indexed under major subject headings. Also included is a cross-listing of technology assessment report citations arranged by type of technology headings, brief descriptions of approximately 70 information sources of potential interest to technology assessors, and addresses and descriptions of 70 organizations with memberships, activities, publications, and other functions relevant to the medical technology assessment community.
Download or read book Congressional Record written by United States. Congress and published by . This book was released on 1970 with total page 1352 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Monthly Catalog of United States Government Publications written by United States. Superintendent of Documents and published by . This book was released on 1966 with total page 1320 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Monthly Catalog of United States Government Publications Cumulative Index written by United States. Superintendent of Documents and published by . This book was released on 1970 with total page 1348 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book U S Government Research Development Reports written by and published by . This book was released on 1970 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Belmont Report written by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published by . This book was released on 1978 with total page 614 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Improving Mental Health Insurance Coverage written by National Institute of Mental Health (U.S.) and published by . This book was released on 1965 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.
Download or read book Checklist of United States Public Documents 1789 1970 Master keyword index to the publication issuing offices of the U S government 1789 1970 written by Daniel W. Lester and published by . This book was released on 1972 with total page 904 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Evaluating Evidence of Mechanisms in Medicine written by Veli-Pekka Parkkinen and published by Springer. This book was released on 2018-07-13 with total page 131 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book is open access under a CC BY license. This book is the first to develop explicit methods for evaluating evidence of mechanisms in the field of medicine. It explains why it can be important to make this evidence explicit, and describes how to take such evidence into account in the evidence appraisal process. In addition, it develops procedures for seeking evidence of mechanisms, for evaluating evidence of mechanisms, and for combining this evaluation with evidence of association in order to yield an overall assessment of effectiveness. Evidence-based medicine seeks to achieve improved health outcomes by making evidence explicit and by developing explicit methods for evaluating it. To date, evidence-based medicine has largely focused on evidence of association produced by clinical studies. As such, it has tended to overlook evidence of pathophysiological mechanisms and evidence of the mechanisms of action of interventions. The book offers a useful guide for all those whose work involves evaluating evidence in the health sciences, including those who need to determine the effectiveness of health interventions and those who need to ascertain the effects of environmental exposures.
Download or read book Panel on Science and Technology Eleventh Meeting the Mangement of Information and Knowledge Proceedings 91 2 Jan 27 28 and 29 1970 written by United States. Congress. House. Science and Astronautics and published by . This book was released on 1970 with total page 260 pages. Available in PDF, EPUB and Kindle. Book excerpt:
