Download or read book International Standards for Clinical Trial Registries The Registration of All Interventional Trials is a Scientific Ethical and Moral Responsibility written by and published by . This book was released on 2018 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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 Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 396 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book International Ethical Guidelines for Health Related Research Involving Humans written by Council for International Organizations of Medical Sciences (CIOMS) and published by World Health Organization. This book was released on 2017-01-31 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.

Download or read book Clinical Trial Registries written by MaryAnn Foote and published by Springer Science & Business Media. This book was released on 2006-11-09 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: ICMJE editors and other journal editors require registration of clinical trial information on publicly available Web sites before enrollment of study subjects. Not only does this book discuss the genesis of these requirements, it also provides practical information for researchers and sponsors on how to establish a workflow for a clinical registry project, how to file to a registry, and how to post results.

Download or read book Developing a National Registry of Pharmacologic and Biologic Clinical Trials written by Institute of Medicine and published by National Academies Press. This book was released on 2006-07-12 with total page 124 pages. Available in PDF, EPUB and Kindle. Book excerpt: To improve public confidence in clinical research, a number of public and private groups have called for a publicly accessible, comprehensive, and transparent registry of relevant information on clinical trials for drugs and biologics. The public and various entities within the medical community (health care providers, researchers, medical journal editors, pharmaceutical companies, health insurers, and regulators) have different expectations and perceived needs regarding a public clinical trial registry. The IOM Committee on Clinical Trial Registries hosted a workshop on June 27, 2005, to obtain much-needed input from members of the public, public advocate groups, and the broader community of journal editors, pharmaceutical and biotech leaders, NIH, and the FDA. Participants discussed the data elements that have been at the core of debate and commented on issues of compliance and implementation of a national clinical trial registry. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report inlcudes discussions at the workshop centered on the following five concepts, and are described within this report: 1) Purpose, 2) Which Trials to Include, 3) Delayed Disclosure Mechanism, 4) Reporting Results of Completed Trials, and 5) Compliance.

Download or read book Principles of Good Clinical Practice written by Michael J. McGraw and published by Pharmaceutical Press. This book was released on 2010 with total page 273 pages. Available in PDF, EPUB and Kindle. Book excerpt: Part of "RPS Pharmacy Business Administration Series", this book offers good clinical practice guidelines. It includes standards on how clinical trials should be conducted, provide assurance of safety and efficacy of various drugs and protect human rights.

Download or read book Quick Guide to Good Clinical Practice written by Cemal Cingi and published by Springer. This book was released on 2016-11-23 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This brand-new book offers a reference guide to understanding and applying the rules for properly conducting clinical trials to meet the international quality standard – Good Clinical Practice – provided by the International Conference on Harmonization (ICH). The work offers an updated perspective on the clinical research landscape within the context of the clinical trial regulatory frameworks in Europe and the USA. In addition to providing a historical review and a detailed definition of GPC regulations, it includes step-by-step explanations of all the requirements that researchers should bear in mind when designing and performing new trials. Further topics covered include: ethics of clinical research; the drug development process and evolution of regulations; investigator and sponsor responsibilities; and clinical trial protocols. Written by clinicians for clinicians, the book represents a valuable read also for researchers, pharmacists and all professionals involved in applications to the ethic committees, whose approval is required for new clinical studies.

Download or read book Mandatory Clinical Trial Registration written by Trudo Lemmens and published by . This book was released on 2014 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 2006, a working group of the World Health Organization recommended the establishment of a mandatory clinical trials registry for all research involving humans. Clinical trials registration prior to subject recruitment is required by many major medical journals, and several national regulators either introduced registration requirements or are considering doing so. While the principle of trial registration has been widely endorsed, including by the pharmaceutical industry, its content and modus operandi has been the subject of debate. Industry has claimed that registration of some of WHO's required registration elements could impact negatively on intellectual property rights and undermine the competitive advantage of pharmaceutical innovators. This chapter discusses first what the WHO clinical trials registration initiative proposes. It then provides an overview of the ethical and public policy reasons behind clinical trials registration. These provide the background from which to analyze the arguments that have been invoked in favour of limiting some aspects of trial registration. Clinical trials registration should not be seen as a potential threat for intellectual property rights over pharmaceutical products. In addition, the interest in gaining a competitive advantage cannot outweigh the public interest in registration of clinical trials. Registration of trials will, however, not be sufficient to solve some of the significant problems associated with industry's control over the design, conduct, analysis, and reporting of results. The chapter ends with an endorsement of the need for further regulatory initiatives.

Download or read book Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Biomedical Research written by Council of Europe and published by Council of Europe. This book was released on 2005-01-01 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt: This protocol covers the full range of research activities in the health field that involve interventions on human beings. It aims to protect the dignity and identity of everyone involved, without discrimination.

Download or read book Reviewing Clinical Trials written by Chinese University of Hong Kong and published by . This book was released on 2010 with total page 153 pages. Available in PDF, EPUB and Kindle. Book excerpt: The idea for this manual came from Pfizer in the US, which provided the Clinical Trials Centre at The University of Hong Kong, Hong Kong SAR, PR China with a nonbinding grant for its development. The general project layout protocol was accepted by Pfizer in July 2009. Pfizer has not in any way interfered with the project, except for providing nonbinding comments to the final product. The entire text of this manual was written by Johan PE Karlberg. Marjorie A Speers provided considerable and essential comments on the contents and the first and subsequent drafts. A group of international human research protection experts mostly working in non-profit institutions or organisations - see Contributors for details - reviewed and provided important comments on the contents and final draft. It was solely created with the intention to promote human research protection of participants in clinical trials. This manual will be translated into numerous languages and is provided free of charge as an electronic file over the Internet (http://www.ClinicalTrialMagnifier.com) and offered in print for a fee. The objective beyond this project is to establish educational activities, developed around the manual, and jointly organised with leading academic institutions worldwide.

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 MEDINFO 2023 The Future Is Accessible written by J. Bichel-Findlay and published by IOS Press. This book was released on 2024-04-02 with total page 1676 pages. Available in PDF, EPUB and Kindle. Book excerpt: Science-fiction author William Gibson is famously quoted as saying, “The future is already here – it's just not very evenly distributed.” During the Covid pandemic, telehealth and remote monitoring were elevated from interesting innovations to essential tools in many healthcare systems, but not all countries had the infrastructure necessary to pivot quickly, amply demonstrating the negative consequences of the digital divide. This book presents the proceedings of MedInfo 2023, the 19th World Congress on Medical and Health Informatics, held from 8 – 12 July 2023 in Sydney, Australia. This series of biennial conferences provides a platform for the discussion of applied approaches to data, information, knowledge, and wisdom in health and wellness. The theme and title of MedInfo 2023 was The Future is Accessible, but the digital divide is a major concern for health and care-informatics professionals, whether because of global economic disparities, digital literacy gaps, or limited access to reliable information about health. A total of 935 submissions were received for the conference, of which 228 full papers, 43 student papers and 117 posters were accepted following a thorough peer-review process involving 279 reviewers. Topics covered include: information and knowledge management; quality, safety and outcomes; health data science; human, organizational and social aspects; and global health informatics. Significant advances in artificial intelligence, machine learning, augmented reality, virtual reality, and genomics hold great hope for future healthcare planning, delivery, management, education, evaluation, and research, and this book will be of interest to all those working to not only exploit the benefits of these technologies, but also to identify ways to overcome their associated challenges.

Download or read book Quantitative Methods for Health Research written by Bruce and published by John Wiley & Sons. This book was released on 2017-12-06 with total page 568 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical introduction to epidemiology, biostatistics, and research methodology for the whole health care community This comprehensive text, which has been extensively revised with new material and additional topics, utilizes a practical slant to introduce health professionals and students to epidemiology, biostatistics, and research methodology. It draws examples from a wide range of topics, covering all of the main contemporary health research methods, including survival analysis, Cox regression, and systematic reviews and meta-analysis—the explanation of which go beyond introductory concepts. This second edition of Quantitative Methods for Health Research: A Practical Interactive Guide to Epidemiology and Statistics also helps develop critical skills that will prepare students to move on to more advanced and specialized methods. A clear distinction is made between knowledge and concepts that all students should ensure they understand, and those that can be pursued further by those who wish to do so. Self-assessment exercises throughout the text help students explore and reflect on their understanding. A program of practical exercises in SPSS (using a prepared data set) helps to consolidate the theory and develop skills and confidence in data handling, analysis, and interpretation. Highlights of the book include: Combining epidemiology and bio-statistics to demonstrate the relevance and strength of statistical methods Emphasis on the interpretation of statistics using examples from a variety of public health and health care situations to stress relevance and application Use of concepts related to examples of published research to show the application of methods and balance between ideals and the realities of research in practice Integration of practical data analysis exercises to develop skills and confidence Supplementation by a student companion website which provides guidance on data handling in SPSS and study data sets as referred to in the text Quantitative Methods for Health Research, Second Edition is a practical learning resource for students, practitioners and researchers in public health, health care and related disciplines, providing both a course book and a useful introductory reference.

Download or read book New COVID 19 Variants Diagnosis and Management in the Post Pandemic Era written by Ozgur Karcioglu and published by BoD – Books on Demand. This book was released on 2024-04-18 with total page 198 pages. Available in PDF, EPUB and Kindle. Book excerpt: New COVID-19 Variants - Diagnosis and Management in the Post-Pandemic Era provides a comprehensive overview of COVID-19, focusing on new variants and their diagnosis, treatment, and prevention. Due to the emergence of new viral variants, cases of COVID-19 are expected to increase. Thus, it is vital to take the necessary precautions to protect society and its most vulnerable members like the elderly and immunocompromised. This book discusses protective measures such as social distancing, mask mandates, vaccinations, and more.

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 The Clinical Trials Landscape in Australia 2006 2015 written by Askie and published by . This book was released on 2017-12-22 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: