The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
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.
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.
Drawing on the work of the Roundtable on Evidence-Based Medicine, the 2007 IOM Annual Meeting assessed some of the rapidly occurring changes in health care related to new diagnostic and treatment tools, emerging genetic insights, the developments in information technology, and healthcare costs, and discussed the need for a stronger focus on evidence to ensure that the promise of scientific discovery and technological innovation is efficiently captured to provide the right care for the right patient at the right time. As new discoveries continue to expand the universe of medical interventions, treatments, and methods of care, the need for a more systematic approach to evidence development and application becomes increasingly critical. Without better information about the effectiveness of different treatment options, the resulting uncertainty can lead to the delivery of services that may be unnecessary, unproven, or even harmful. Improving the evidence-base for medicine holds great potential to increase the quality and efficiency of medical care. The Annual Meeting, held on October 8, 2007, brought together many of the nation's leading authorities on various aspects of the issues - both challenges and opportunities - to present their perspectives and engage in discussion with the IOM membership.
This work provides a thought-provoking account of how medical treatments can be tested with unbiased or 'fair' trials and explains how patients can work with doctors to achieve this vital goal. It spans the gamut of therapy from mastectomy to thalidomide and explores a vast range of case studies.
Infections caused by fungi have recently attracted the attention of both clinicians and basic researchers given the heavy burden they represent for any health system. The mortality and morbidity rates associated to mycosis are progressively rising simply because some of these diseases are still neglected by health-care workers and due to the changing sensitivity to antifungal drugs displayed by these organisms. In this book, both researchers and clinicians working in the medical mycology field explore the most recent literature about specific mycosis; placing in one concise chapter thoroughly revisions of the current knowledge on virulence factors, recognition by immune cells, immunoevasion, epidemiology, new diagnosis trends and therapeutics. This book is recommended to researchers, physicians and students interested in medical mycology.
Progress and Challenges in Precision Medicine presents an insightful overview to the myriad factors of personalized and precision medicine. The availability of the human genome, large amounts of data on individual genetic variations, environmental interactions, influence of lifestyle, and cutting-edge tools and technologies for big-data analysis have led to the age of personalized and precision medicine. Bringing together a global range of experts on precision medicine, this book collects previously scattered information into one concise volume which covers the most important developments so far in precision medicine and also suggests the most likely avenues for future development. The book includes clinical information, informatics, public policy implications, and information on case studies. It is a useful reference and background work for students, researchers, and clinicians working in the biomedical and medical fields, as well as policymakers in the health sciences. - Provides an overview of the growing field of precision medicine - Contains chapters from geographically diverse experts in their field - Explores important aspects of precision medicine, including applications, ethics, and development
“I thoroughly enjoyed reading this book as it has taken me on a journey through time, across the globe and through multiple disciplines. Indeed, we need to be thinking about these concepts and applying them every day to do our jobs better.” Farah Magrabi, Macquarie University, Australia “The reader will find intriguing not only the title but also the content of the book. I’m also pleased that public health, and even more specifically epidemiology has an important place in this ambitious discussion.” Elena Andresen, Oregon Health & Science University, USA “This book is very well written and addresses an important topic. It presents many reasons why basic scientists/researchers should establish collaborations and access information outside traditional means and not limit thinking but rather expand such and perhaps develop more innovative and translational research ventures that will advance science and not move it laterally.” Gerald Pepe, Eastern Virginia Medical School, USA “This book gathers logically and presents interestingly (with many examples) the qualities and attitudes a researcher must possess in order to become successful. On the long run, the deep and carefully reexamined research will be the one that lasts.” Zoltán Néda, Babeş-Bolyai University, Romania “I really liked the five pillars delineating the components of humanism in research. This book has made a major contribution to the research ethics literature.” David Fleming, University of Missouri, USA A comprehensive review of the research phase of life sciences from design to discovery with suggestions to improve innovation This vital resource explores the creative processes leading to biomedical innovation, identifies the obstacles and best practices of innovative laboratories, and supports the production of effective science. Innovative Research in Life Sciences draws on lessons from 400 award-winning scientists and research from leading universities. The book explores the innovative process in life sciences and puts the focus on how great ideas are born and become landmark scientific discoveries. The text provides a unique resource for developing professional competencies and applied skills of life sciences researchers. The book examines what happens before the scientific paper is submitted for publication or the innovation becomes legally protected. This phase is the most neglected but most exciting in the process of scientific creativity and innovation. The author identifies twelve competencies of innovative biomedical researchers that described and analyzed. This important resource: Highlights the research phase from design to discovery that precedes innovation disclosure Offers a step by step explanation of how to improve innovation Offers solutions for improving research and innovation productivity in the life sciences Contains a variety of statistical databases and a vast number of stories about individual discoveries Includes a process of published studies and national statistics of biomedical research and reviews the performance of research labs and academic institutions Written for academics and researchers in biomedicine, pharmaceutical science, life sciences, drug discovery, pharmacology, Innovative Research in Life Sciences offers a guide to the creative processes leading to biomedical innovation and identifies the best practices of innovative scientists and laboratories.
Aspirin serves as one of the leading agents for cardiovascular treatment in women. However, many patients have experienced negative side effects of internal bleeding and lining damage due to strong amounts of acid in the drug. This book presents medical and biological research.
