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 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 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 Behavioral Clinical Trials for Chronic Diseases written by Lynda H. Powell and published by Springer. This book was released on 2020-04-06 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the first comprehensive guide to the design of behavioral randomized clinical trials (RCT) for chronic diseases. It includes the scientific foundations for behavioral trial methods, problems that have been encountered in past behavioral trials, advances in design that have evolved, and promising trends and opportunities for the future. The value of this book lies in its potential to foster an ability to “speak the language of medicine” through the conduct of high-quality behavioral clinical trials that match the rigor commonly seen in double-blind drug trials. It is relevant for testing any treatment aimed at improving a behavioral, social, psychosocial, environmental, or policy-level risk factor for a chronic disease including, for example, obesity, sedentary behavior, adherence to treatment, psychosocial stress, food deserts, and fragmented care. Outcomes of interest are those that are of clinical significance in the treatment of chronic diseases, including standard risk factors such as cholesterol, blood pressure, and glucose, and clinical outcomes such as hospitalizations, functional limitations, excess morbidity, quality of life, and mortality. This link between behavior and chronic disease requires innovative clinical trial methods not only from the behavioral sciences but also from medicine, epidemiology, and biostatistics. This integration does not exist in any current book, or in any training program, in either the behavioral sciences or medicine.

Download or read book The Future of Public Health written by Committee for the Study of the Future of Public Health and published by National Academies Press. This book was released on 1988-01-15 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The Nation has lost sight of its public health goals and has allowed the system of public health to fall into 'disarray'," from The Future of Public Health. This startling book contains proposals for ensuring that public health service programs are efficient and effective enough to deal not only with the topics of today, but also with those of tomorrow. In addition, the authors make recommendations for core functions in public health assessment, policy development, and service assurances, and identify the level of government--federal, state, and local--at which these functions would best be handled.

Download or read book Clinical Trials written by Tom Brody and published by Academic Press. This book was released on 2016-02-19 with total page 897 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials. Contains new and fully revised material on key topics such as biostatistics, biomarkers, orphan drugs, biosimilars, drug regulations in Europe, drug safety, regulatory approval and more Extensively covers the "study schema" and related features of study design Incorporates laboratory data from studies on human patients to provide a concrete tool for understanding the concepts in the design and conduct of clinical trials Includes decisions made by FDA reviewers when granting approval of a drug as real world learning examples for readers

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 Economic Evaluation in Clinical Trials written by Henry A. Glick and published by Handbooks in Health Economic E. This book was released on 2014-10-02 with total page 265 pages. Available in PDF, EPUB and Kindle. Book excerpt: It is increasingly important to examine the relationship between the outcomes of a clinical trial and the costs of the medical therapy under study. This book provides a practical guide to the techniques and issues involved in conducting economic evaluation in ongoing clinical trials, supported with examples.

Download or read book The Social Impact of AIDS in the United States written by National Research Council and published by National Academies Press. This book was released on 1993-02-01 with total page 337 pages. Available in PDF, EPUB and Kindle. Book excerpt: Europe's "Black Death" contributed to the rise of nation states, mercantile economies, and even the Reformation. Will the AIDS epidemic have similar dramatic effects on the social and political landscape of the twenty-first century? This readable volume looks at the impact of AIDS since its emergence and suggests its effects in the next decade, when a million or more Americans will likely die of the disease. The Social Impact of AIDS in the United States addresses some of the most sensitive and controversial issues in the public debate over AIDS. This landmark book explores how AIDS has affected fundamental policies and practices in our major institutions, examining: How America's major religious organizations have dealt with sometimes conflicting values: the imperative of care for the sick versus traditional views of homosexuality and drug use. Hotly debated public health measures, such as HIV antibody testing and screening, tracing of sexual contacts, and quarantine. The potential risk of HIV infection to and from health care workers. How AIDS activists have brought about major change in the way new drugs are brought to the marketplace. The impact of AIDS on community-based organizations, from volunteers caring for individuals to the highly political ACT-UP organization. Coping with HIV infection in prisons. Two case studies shed light on HIV and the family relationship. One reports on some efforts to gain legal recognition for nonmarital relationships, and the other examines foster care programs for newborns with the HIV virus. A case study of New York City details how selected institutions interact to give what may be a picture of AIDS in the future. This clear and comprehensive presentation will be of interest to anyone concerned about AIDS and its impact on the country: health professionals, sociologists, psychologists, advocates for at-risk populations, and interested individuals.

Download or read book An Index to Clinical Research in the Federal Health Programs Service written by United States. Federal Health Programs Service and published by . This book was released on 1970 with total page 92 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Clinical Epidemiology written by Diederick E. Grobbee and published by Jones & Bartlett Publishers. This book was released on 2014-01-23 with total page 498 pages. Available in PDF, EPUB and Kindle. Book excerpt: Now updated with new data and examples throughout, Clinical Epidemiology: Principles, Methods, and Applications for Clinical Research, Second Edition is a comprehensive resource that introduces the reader to the basics of clinical epidemiology and explores the principles and methods that can be used to obtain quantitative evidence on the effects of interventions and on the diagnosis, etiology, and prognosis of disease. The everyday challenges of clinical research and the quantitative knowledge required to practice medicine are also examined, making this book a valuable reference for both graduate and undergraduate students in medicine and related disciplines, as well as for professionals involved in the design and conduct of clinical research.

Download or read book Envisioning a Transformed Clinical Trials Enterprise in the United States written by Institute of Medicine and published by National Academies Press. This book was released on 2012-09-13 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop.

Download or read book Sharing Clinical Research Data written by Institute of Medicine and published by National Academies Press. This book was released on 2013-06-07 with total page 157 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical companies, academic researchers, and government agencies such as the Food and Drug Administration and the National Institutes of Health all possess large quantities of clinical research data. If these data were shared more widely within and across sectors, the resulting research advances derived from data pooling and analysis could improve public health, enhance patient safety, and spur drug development. Data sharing can also increase public trust in clinical trials and conclusions derived from them by lending transparency to the clinical research process. Much of this information, however, is never shared. Retention of clinical research data by investigators and within organizations may represent lost opportunities in biomedical research. Despite the potential benefits that could be accrued from pooling and analysis of shared data, barriers to data sharing faced by researchers in industry include concerns about data mining, erroneous secondary analyses of data, and unwarranted litigation, as well as a desire to protect confidential commercial information. Academic partners face significant cultural barriers to sharing data and participating in longer term collaborative efforts that stem from a desire to protect intellectual autonomy and a career advancement system built on priority of publication and citation requirements. Some barriers, like the need to protect patient privacy, pre- sent challenges for both sectors. Looking ahead, there are also a number of technical challenges to be faced in analyzing potentially large and heterogeneous datasets. This public workshop focused on strategies to facilitate sharing of clinical research data in order to advance scientific knowledge and public health. While the workshop focused on sharing of data from preplanned interventional studies of human subjects, models and projects involving sharing of other clinical data types were considered to the extent that they provided lessons learned and best practices. The workshop objectives were to examine the benefits of sharing of clinical research data from all sectors and among these sectors, including, for example: benefits to the research and development enterprise and benefits to the analysis of safety and efficacy. Sharing Clinical Research Data: Workshop Summary identifies barriers and challenges to sharing clinical research data, explores strategies to address these barriers and challenges, including identifying priority actions and "low-hanging fruit" opportunities, and discusses strategies for using these potentially large datasets to facilitate scientific and public health advances.

Download or read book Textbook of Clinical Trials written by David Machin and published by Wiley. This book was released on 2004-03-12 with total page 428 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive volume on clinical trials that covers all important disease and therapeutic areas together with methodologies, phase I/II/III studies and other issues. The volume catalogues the impact of clinical trials on the practice of medicine and discusses the developments and practice of medical statistics. Cancer, cardiovascular disease, dermatological, dental, mental, ophthalmic health, gynaecology and respiratory diseases are all discussed in separate chapters, with discussions on outcome measures, competing risks and statistical models given for each therapy area. It also presents: * A history of clinical trials * A summary of pertinent statistical issues * How to choose a clinical trial design * Ethical constraints and considerations * Clinical trial issues in paediatrics and those involving older patients * Clinical trials in complementary medicine

Download or read book Collaboration across Health Research and Medical Care written by Bart Penders and published by Ashgate Publishing, Ltd.. This book was released on 2015-03-28 with total page 247 pages. Available in PDF, EPUB and Kindle. Book excerpt: Health research and health care practice are radically transforming as governments invest more in large scale, national and international health projects with increasing levels of interdisciplinarity as populations age and as nations grow wealthier. This volume examines the structures and dynamics of scientific collaboration in health research and health care. Bringing together detailed research from the US, Canada, Europe and Japan, Collaboration Across Health Research and Medical Care sheds light on the features, environments and relationships that characterise collaboration in health care and research, exploring changing patterns of collaboration and examining the causes and consequences of team work in the health domain. With attention to the increasingly porous boundaries between health care and research, the book not only investigates research settings, but also considers the manner in which knowledge produced in laboratories and clinics is translated into day-to-day medical and care practice and health initiatives. It offers a rich examination of the political, technical and organisational facets of collaboration and the implications of changes in collaboration for every day treatment and practice, Collaboration Across Health Research and Medical Care will be of interest to scholars of sociology and science and technology studies, as well as those working in the field of health policy and research.

Download or read book Understanding Medical Research written by John A. Goodfellow and published by John Wiley & Sons. This book was released on 2012-04-16 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical students and junior and senior doctors are frequently called upon to give research presentations, write reports, and answer exam questions on specific areas of medical research. Understanding Medical Research: The Studies That Shaped Medicine is an exciting new title that offers a unique and valuable approach to understanding historically influential studies in important areas of medicine. Featuring chapters from Sir Liam Donaldson and Sir David Weatherall, amongst others, world leading researchers identify ten primary research papers that have shaped the direction of research in their given topic, examining why they were carried out, key findings, and how they changed the field. Each chapter also contains short sections on ‘Key Questions Remaining’ which outline outstanding areas where further research is needed, and a link to ‘Key Laboratories/Clinics’ which point the reader to major research groups of international standing. Covering the seminal research in core areas of medicine, Understanding Medical Research provides an authoritative framework on each topic for medical students and healthcare professionals.

Download or read book Examining the Impact of Real World Evidence on Medical Product Development written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-04-05 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized controlled trials (RCTs) have traditionally served as the gold standard for generating evidence about medical interventions. However, RCTs have inherent limitations and may not reflect the use of medical products in the real world. Additionally, RCTs are expensive, time consuming, and cannot answer all questions about a product or intervention. Evidence generated from real-world use, such as real-world evidence (RWE) may provide valuable information, alongside RCTs, to inform medical product decision making. To explore the potential for using RWE in medical product decision making, the National Academies of Sciences, Engineering, and Medicine planned a three-part workshop series. The series was designed to examine the current system of evidence generation and its limitations, to identify when and why RWE may be an appropriate type of evidence on which to base decisions, to learn from successful initiatives that have incorporated RWE, and to describe barriers that prevent RWE from being used to its full potential. This publication summarizes the discussions from the entire workshop series.